ANTERION

{0} FDA U.S. FOOD & DRUG ADMINISTRATION September 11, 2026 Heidelberg Engineering GmbH % Lena Sattler Consultant Orasi Consulting, LLC 226 1st St. Bonita Springs, Florida 34134 Re: K261019 Trade/Device Name: Anterion Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: OBO Dated: August 3, 2026 Received: August 3, 2026 Dear Lena Sattler: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K261019 - Lena Sattler Page 2 Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). {2} K261019 - Lena Sattler Page 3 Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # BRADLEY S. CUNNINGHAM -S CAPT Bradley Cunningham, MSE, RAC Acting Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} | Indications for Use | | | | --- | --- | --- | | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K261019 | ? | | Please provide the device trade name(s). | | ? | | ANTERION | | | | Please provide your Indications for Use below. | | ? | | The ANTERION is a non-contact ophthalmic imaging and analysis device for the eye. It is intended for visualization and measurement of the anterior segment and measurement of the axial length.The analysis covers:Cornea ThicknessAnterior Segmento Anterior chamber width, depth, volume and angle parameterso Lens ThicknessAxial Length | | | | Please select the types of uses (select one or both, as applicable). | Prescription Use (21 CFR 801 Subpart D)Over-The-Counter Use (21 CFR 801 Subpart C) | ? | | Please select the age group(s) for which the device(s) is to be used. | Neonates/Newborns (Birth to < 29 days old)Infants (29 days old to < 2 years old)Children (2 years old to < 12 years old)Adolescents (12 years old to < 22 years old)Adults (22 years old and greater) | ? | {4} K261019 # 510(K) SUMMARY Date Prepared September 10, 2026 ## SPONSOR/510(K) OWNER/ MANUFACTURER Heidelberg Engineering GmbH Max-Jarecki-Strasse 8 69115 Heidelberg, Germany Telephone: +49 6221 / 64 63 0 Facsimile: +49 6221 / 64 63 62 Email: arianna.schoess.vargas@heidelbergengineering.com Establishment Registration No.: 8043762 ## OFFICIAL CONTACT PERSON Lena Sattler Orasi Consulting, LLC. 226 1st Street Bonita Springs, FL 34134 Telephone: (440) 554-3706 Facsimile: (866) 904-4315 E-mail: lena@orasiconsulting.com ## PROPRIETARY OR TRADE NAMES ANTERION ## CLASSIFICATION INFORMATION Regulation Number: 21 CFR 886.1570 Classification name: Ophthalmoscope, Tomography, Optical Coherence Medical Specialty Ophthalmic Device Class: II Classification Panel: Ophthalmic Device Panel Product Code: OBO ## PREDICATE DEVICE ANTERION (K240924), Heidelberg Engineering GmbH Heidelberg Engineering GmbH K261019 Traditional 510(k): ANTERION Page 1 of 13 {5} # INDICATIONS FOR USE The ANTERION is a non-contact ophthalmic imaging and analysis device for the eye. It is intended for visualization and measurement of the anterior segment and the measurement of the axial length. The analysis covers: - Cornea Thickness - Anterior Segment ○ Anterior chamber width, depth, volume and angle parameters ○ Lens Thickness - Axial Length # GENERAL DEVICE DESCRIPTION The ANTERION is a diagnostic imaging device for the eye. The technology is based on swept-source optical coherence tomography (SS-OCT) technology. The device itself has two basic component groups: - ANTERION Hardware (Imager/Base) with integrated forehead/ chin rest: The hardware includes imaging hardware (e.g., laser, LEDs, optics, detectors, hardware for spatial encoding) as well as a touch screen. - ANTERION Software (V.1.5.2) (PC): The ANTERION Software includes the main user interface. The software allows for device control, such as selection of examination(s) and imaging parameter(s). The ANTERION software provides an interface for an external Patient Data Management System. The ANTERION hardware is separated in three parts: the Base (bottom part), the Imager (top part), and the Head Rest (forehead/chin rest). For examinations, the patient places his/her head in the forehead/chin rest. The Head Rest is mechanically and electronically connected to the Base and controlled via a joystick. Within its stand, a stepper motor with additional mechanic parts and a controller board are placed, allowing the operator to move the motorized chin rest up or down for optimally positioning the patients' eye. An external fixation light is mounted at the forehead rest. The Base mainly contains the power supply and PC connection of the device. In the Imager, the components for scanning, signal generation, and signal processing are contained. The operator directly accesses two software modules, which are named AQM (acquisition module) and VWM (viewing module). The AQM allows selecting between examinations. The VWM shows acquired images, parameters, and reports. The ANTERION device contains two imaging modalities, a scanning optical coherence tomography (OCT) modality and an infrared (IR) camera. The OCT modality allows for cross-sectional imaging and biometry, while the IR camera allows Heidelberg Engineering GmbH K261019 Traditional 510(k): ANTERION Page 2 of 13 {6} for en-face imaging of a patient's eye. The ANTERION device provides four separate software functionalities (Apps) to acquire various imaging and measurements of the anterior segment of the eye: (1) the Imaging App, (2) the Cornea App, (3) the Cataract App and (4) the Metrics App. The Cornea App provides tomographic data and measurements for the patient's individual corneal geometry and corneal characteristics. The Cornea App provides tomographic data and parameters, such as corneal curvature and thickness. The Cataract App provides key measurements for cataract surgery planning, such as corneal thickness, anterior chamber depth and axial length. The Metrics App generates OCT images and scan parameters for the anterior chamber such as anterior chamber angle and volume. The four ANTERION Apps are locked/unlocked independently by a license mechanism for each App. The software implementation of these Apps is realized within the AQM and VWM. The following modification has been applied to the device, subject of this 510(k): - Addition of the automatic scleral spur detection (separate license in the Metrics App) with automatic measurements of scleral spur-related parameters. To function as intended, the ANTERION must be connected to an external Patient Data Management System with compatible interface. To date, HEYEX 2 / HEYEX PACS is the only available system with compatible interface. ## COMPARISON OF TECHNOLOGICAL CHARACTERISTICS BETWEEN THE SUBJECT AND THE PREDICATE DEVICE The subject ANTERION is a device modification to the predicate device ANTERION (K240924). The technological characteristics of the subject ANTERION differ from those of the predicate device, however, the differences do not raise new or different questions of safety or effectiveness. The software of both devices, the subject ANTERION and the predicate ANTERION (K240924), includes all available imaging functions (Imaging App, Cornea App, Cataract App, Metrics App) which are locked/unlocked independently by a license mechanism for each App. The main difference between both devices is a software modification which provides automatic measurements of scleral spur-related parameters. This change, i.e. the automatic scleral spur detection, doesn't change the data acquisition process, the intended use/indications for use or the used imaging technologies (OCT, IR camera) of ANTERION. Heidelberg Engineering GmbH K261019 Traditional 510(k): ANTERION Page 3 of 13 {7} # INDICATIONS FOR USE STATEMENT CHART | SUBJECT DEVICE ANTERION | PREDICATE DEVICE ANTERION (K240924) | Same, similar or different | | --- | --- | --- | | The ANTERION is a non-contact ophthalmic imaging and analysis device for the eye. It is intended for visualization and measurement of the anterior segment and the measurement of the axial length. The analysis covers: • Cornea thickness • Anterior segment ○ Anterior chamber width, depth, volume, and angle parameters ○ Lens thickness • Axial Length | The ANTERION is a non-contact ophthalmic imaging and analysis device for the eye. It is intended for visualization and measurement of the anterior segment and the measurement of the axial length. The analysis covers: • Cornea thickness • Anterior segment ○ Anterior chamber width, depth, volume, and angle parameters ○ Lens thickness • Axial Length | Same | # TECHNOLOGICAL CHARACTERISTICS COMPARISON CHART (Differences are highlighted in grey) | | SUBJECT DEVICE ANTERION | PREDICATE DEVICE ANTERION (K240924) | Same, similar or different | | --- | --- | --- | --- | | Main Technology | Swept Source OCT Technology | Swept Source OCT Technology | Same | | Supporting Technologies | Infrared Camera | Infrared Camera | Same | | OCT center wave length | 1310 nm | 1310 nm | Same | | OCT axial resolution | <10 μm (tissue) | <10 μm (tissue) | Same | | OCT lateral resolution | 30 μm, 45 μm | 30 μm, 45 μm | Same | | Scan length | 5 – 16.5 mm | 5 – 16.5 mm | Same | | Number of A-Scans per B-Scan | 256; 512; 768; 1024 | 256; 512; 768; 1024 | Same | | A-scan rate | 50,000 Hz | 50,000 Hz | Same | | Number of B- Scans | 1-65 | 1-65 | Same | | Scan Pattern | Line, Volume, Arc, Radial | Line, Volume, Arc, Radial | Same | | Scan Center | Adjustable | Adjustable | Same | | Tracking | Available | Available | Same | | Number of averaged Scans | 1; 2; 4; 8 | 1; 2; 4; 8 | Same | | IR camera image size (px) | 768 x 576 | 768 x 576 | Same | | Software Functions | • Imaging App • Cornea App • Cataract App • Metrics App | • Imaging App • Cornea App • Cataract App • Metrics App | Same | | Main Parameters of Cornea App | Cornea App: • Cornea Curvature • Cornea Thickness - Epithelial Thickness - Stromal Thickness | Cornea App: • Cornea Curvature • Cornea Thickness - Epithelial Thickness - Stromal Thickness | Same | | Scleral Spur Detection (Metrics App) | Manual scleral spur annotation | Automatic scleral spur detection | Similar: Output of both methods is similar, manual adjustment of automatically detected scleral spur is possible. | | Scan types for corneal thickness parameters | 65 B-Scans (Cornea App) | 65 B-Scans (Cornea App) | Same | Heidelberg Engineering GmbH K261019 Traditional 510(k): ANTERION Page 4 of 13 {8} | | SUBJECT DEVICE ANTERION | PREDICATE DEVICE ANTERION (K240924) | Same, similar or different | | --- | --- | --- | --- | | Dilation of pupil required? | No | No | Same | | Eye contact required? | No | No | Same | | Fixation light | Internal, external | Internal, external | Same | | Working position | Upright sitting position of the patient, using chin rest | Upright sitting position of the patient, using chin rest | Same | | User Interface | Joystick for user to move and align device, device has GUI (Graphical user interface) for display and analysis of data | Joystick for user to move and align device, device has GUI (Graphical user interface) for display and analysis of data | Same | ## NON-CLINICAL PERFORMANCE TESTING Software documentation was provided, and software verification and validation was conducted as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Documentation regarding cybersecurity was submitted as recommended by FDA's Guidance for Industry and FDA Staff, "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions" and an overall risk assessment regarding security and safety of the device was conducted due to ISO 14971:2019. Tests for electrical safety (IEC 60601-1:2020) and electromagnetic compatibility (IEC 60601-1-2:2020 and IEC TR 60601-4-2: 2016) were performed with ANTERION and passed the relevant requirements of the applied standards. Laser safety testing for the light sources used in ANTERION was previously submitted and showed that the requirements according to FDA recognized standards IEC-60825-1:2007 and ANSI Z80.36:2016 were fulfilled. The test results are still valid for the subject ANTERION. Biocompatibility of the device was previously demonstrated by cytotoxicity testing, skin sensitization testing and chemical analysis according to ISO 10993-5:2009, ISO 10993-10:2021 and ISO 10993-18:2005, respectively, and supported by biocompatibility assessment according to 10993-1:2018. The test results remain valid for the subject ANTERION. ## CLINICAL EVIDENCE The B-2023-1 study was a prospective image grading study using retrospective subject examination data collected and acceptable ANTERION scans acquired at one clinical site in the United States (collected previously in the B-2018-3 study, which was submitted and cleared in K230897) to assess the precision and agreement of scleral spur-related measurements obtained with the Heidelberg Engineering ANTERION Metrics App. ANTERION Metrics App scans from B-2018-3 were sent to an independent reading center. For the agreement analysis, three graders from the reading center each were instructed to manually annotate visible scleral spur(s) for each of the six B-scans on Heidelberg Engineering GmbH K261019 Traditional 510(k): ANTERION Page 5 of 13 {9} the first acceptable ANTERION scan. For the precision analysis, on all acceptable ANTERION scans, automatic scleral spur detection (ASSD) was activated and reviewed by the reading center. Repeatability and reproducibility of measurements was estimated using a two-way, random-effects analysis of variance (ANOVA) model. Agreement was characterized using Bland-Altman and Deming regression analyses. The analysis population of this study included 51 subjects: twenty-five (25) in the Open Angle Eye population and twenty-six (26) in the Narrow Angle Eye population. The following quantitative parameters were evaluated: - Spur-to-Spur Distance [mm] (STS) - Scleral Spur Angle 500 [°] (SSA500) (both sides) - Angle Opening Distance 500 [mm] (AOD500) (both sides) - Trabecular Iris Space Area 500 [mm²] (TISA500) (both sides) - Lens Vault [mm] (LV) Summary figures of the ASSD precision results (Figure 1) and agreement results (Figure 2 and Figure 3) are presented below and focus on the three B-scans oriented in the horizontal directions (i.e. Temporal to Nasal and the B-scans on either side of horizontal). The precision analysis showed that the measurement repeatability and reproducibility SDs between eyes with Open Angles versus Narrow Angles were similar for all parameters. The results were similar for precision of measurements obtained from all scleral spurs placed by ASSD versus when evaluating measurements obtained from only those spur placements deemed acceptable by the reading center. Based on the limits of agreement analysis, the 95%CI of LoA for all parameters included zero in both Open Angle and Narrow Angle Eye Populations. The 95%CI of the mean difference for all parameters and locations in the eyes with Narrow Angle included 0, and in the Open Angle eyes, included 0 with some exceptions, where they are nevertheless close to 0. In the Deming regression analyses for both populations, the majority of 95% CIs of intercept contain 0 and 95% CIs of slope contain 1, with some exceptions where the intercepts are nevertheless close to 0 and slopes are close to 1. Heidelberg Engineering GmbH K261019 Traditional 510(k): ANTERION Page 6 of 13 {10} Figure 1 Summary of Repeatability CV% and Reproducibility CV% of Measurements Based on Scans with Automatic Scleral Spur Detection Placed (ASSD-Placed), Precision Analysis Population Page 1 of 2 | Parameter | # of | # of | Repeatability | Reproducibility | | --- | --- | --- | --- | --- | | Location | Eyes | Scans | CV% (SD/Intercept) | CV% (SD/Intercept) | SSA, * Open Angle Eye | NSN | 23 | 167 | 4.92% (2.166/44.043) | 6.30% (2.773/44.043) | | --- | --- | --- | --- | --- | | N | 25 | 221 | 3.85% (1.790/46.530) | 6.19% (2.881/46.530) | | NIN | 25 | 217 | 4.82% (2.183/45.273) | 5.93% (2.685/45.273) | | TIT | 25 | 221 | 4.96% (2.336/47.101) | 6.68% (3.146/47.101) | | T | 25 | 223 | 4.65% (2.215/47.630) | 7.22% (3.438/47.630) | | TST | 21 | 159 | 5.50% (2.471/44.966) | 6.43% (2.891/44.966) | Narrow Angle Eye | NSN | 23 | 170 | 11.91% (1.895/15.911) | 15.48% (2.463/15.911) | | --- | --- | --- | --- | --- | | N | 26 | 234 | 12.07% (2.171/17.983) | 14.11% (2.537/17.983) | | NIN | 26 | 222 | 13.09% (2.300/17.564) | 15.42% (2.708/17.564) | | TIT | 26 | 212 | 14.53% (2.461/16.941) | 16.59% (2.810/16.941) | | T | 26 | 231 | 15.32% (2.471/16.134) | 17.37% (2.802/16.134) | | TST | 23 | 143 | 18.17% (2.474/13.615) | 25.94% (3.532/13.615) | AOD, mm Open Angle Eye | NSN | 23 | 167 | 6.50% (0.034/0.522) | 9.54% (0.050/0.522) | | --- | --- | --- | --- | --- | | N | 25 | 221 | 6.28% (0.036/0.573) | 9.61% (0.055/0.573) | | NIN | 25 | 217 | 6.50% (0.035/0.533) | 8.93% (0.048/0.533) | | TIT | 25 | 221 | 9.23% (0.053/0.573) | 11.49% (0.066/0.573) | | T | 25 | 223 | 7.08% (0.042/0.597) | 11.32% (0.068/0.597) | | TST | 21 | 159 | 9.14% (0.050/0.547) | 12.15% (0.066/0.547) | Narrow Angle Eye | NSN | 23 | 170 | 12.51% (0.018/0.144) | 16.19% (0.023/0.144) | | --- | --- | --- | --- | --- | | N | 26 | 234 | 13.01% (0.022/0.166) | 15.24% (0.025/0.166) | | NIN | 26 | 222 | 13.60% (0.022/0.162) | 15.99% (0.026/0.162) | | TIT | 26 | 212 | 15.49% (0.024/0.154) | 17.32% (0.027/0.154) | | T | 26 | 231 | 15.59% (0.023/0.147) | 17.75% (0.026/0.147) | | TST | 23 | 143 | 18.53% (0.023/0.122) | 27.32% (0.033/0.122) |  Repeatability and Reproducibility are estimated (REML) from a two-way random-effect ANOVA model of mean (intercept) + operator/device (C) + eye (S) + interaction between operator/device and eye (I) + error (E). Repeatability SD = Square root of the E variance. Reproducibility SD = Square root of the sum of the variances of C, I, and E. SSA = Scleral Spur Angle, AOD = Angle Opening Distance, TISA = Trabecular-Iris Space Area STS = Spur-to-Spur Distance, LV = Lens Vault Location: S = Superior, N = Nasal, I = Inferior, T = Temporal A configuration is defined as a pairing of operator and device. Repeatability CV% = (Repeatability SD)/Intercept × 100%. Reproducibility CV% = (Reproducibility SD)/Intercept × 100%. Different N occurred between the various scleral spur locations or parameters if the scleral spur cannot be detected by the ASSD. Heidelberg Engineering GmbH K261019 Traditional 510(k): ANTERION Page 7 of 13 {11} Figure 1 Summary of Repeatability CV% and Reproducibility CV% of Measurements Based on Scans with Automatic Scleral Spur Detection Placed (ASSD-Placed), Precision Analysis Population Page 2 of 2 | Parameter | # of | # of | Repeatability | Reproducibility | | --- | --- | --- | --- | --- | | Location | Eyes | Scans | CV% (SD/Intercept) | CV% (SD/Intercept) | TISA, mm² | Open Angle Eye | | | | | | --- | --- | --- | --- | --- | | NSN | 23 | 161 | 7.72% (0.014/0.177) | 11.02% (0.020/0.177) | | N | 25 | 209 | 6.95% (0.014/0.200) | 10.25% (0.020/0.200) | | NIN | 25 | 201 | 8.01% (0.014/0.175) | 9.26% (0.016/0.175) | | TIT | 25 | 216 | 9.43% (0.018/0.187) | 11.71% (0.022/0.187) | | T | 25 | 220 | 8.06% (0.017/0.208) | 11.82% (0.025/0.208) | | TST | 21 | 159 | 8.84% (0.016/0.186) | 11.60% (0.022/0.186) | | Narrow Angle Eye | | | | | | NSN | 23 | 170 | 13.86% (0.007/0.048) | 16.88% (0.008/0.048) | | N | 26 | 227 | 13.05% (0.007/0.056) | 15.67% (0.009/0.056) | | NIN | 26 | 216 | 15.48% (0.008/0.054) | 17.22% (0.009/0.054) | | TIT | 26 | 206 | 17.95% (0.010/0.056) | 21.39% (0.012/0.056) | | T | 26 | 215 | 15.42% (0.008/0.054) | 19.42% (0.011/0.054) | | TST | 23 | 128 | 23.58% (0.010/0.042) | 32.59% (0.014/0.042) | | STS, mm | | | | | | Open Angle Eye | | | | | | NSN to TIT | 23 | 163 | 0.31% (0.038/11.961) | 0.36% (0.044/11.961) | | N to T | 25 | 219 | 0.23% (0.027/11.936) | 0.29% (0.034/11.936) | | NIN to TST | 21 | 151 | 0.30% (0.036/11.912) | 0.39% (0.046/11.912) | | Narrow Angle Eye | | | | | | NSN to TIT | 23 | 153 | 0.36% (0.043/11.899) | 0.49% (0.059/11.899) | | N to T | 26 | 231 | 0.31% (0.036/11.896) | 0.37% (0.044/11.896) | | NIN to TST | 23 | 139 | 0.39% (0.046/11.922) | 0.47% (0.056/11.922) | | LV, mm | | | | | | Open Angle Eye | | | | | | NSN to TIT | 23 | 163 | 22.78% (0.017/0.073) | 36.61% (0.027/0.073) | | N to T | 25 | 219 | 27.91% (0.016/0.056) | 39.74% (0.022/0.056) | | NIN to TST | 21 | 151 | 23.91% (0.021/0.088) | 31.85% (0.028/0.088) | | Narrow Angle Eye | | | | | | NSN to TIT | 23 | 153 | 2.31% (0.018/0.767) | 3.49% (0.027/0.767) | | N to T | 25 | 222 | 2.18% (0.016/0.745) | 2.91% (0.022/0.745) | | NIN to TST | 23 | 139 | 2.87% (0.022/0.755) | 3.40% (0.026/0.755) |  Repeatability and Reproducibility are estimated (REML) from a two-way random-effect ANOVA model of mean (intercept) + operator/device (C) + eye (S) + interaction between operator/device and eye (I) + error (E). Repeatability SD = Square root of the E variance. Reproducibility SD = Square root of the sum of the variances of C, I, and E. SSA = Scleral Spur Angle, AOD = Angle Opening Distance, TISA = Trabecular-Iris Space Area STS = Spur-to-Spur Distance, LV = Lens Vault Location: S = Superior, N = Nasal, I = Inferior, T = Temporal A configuration is defined as a pairing of operator and device. Repeatability CV% = (Repeatability SD)/Intercept × 100%. Reproducibility CV% = (Reproducibility SD)/Intercept × 100%. Different N occurred between the various scleral spur locations or parameters if the scleral spur cannot be detected by the ASSD. Heidelberg Engineering GmbH K261019 Traditional 510(k): ANTERION Page 8 of 13 {12} Figure 2 Summary of Limit of Agreement for Measurements Between Automatic Scleral Spur Detection (ASSD-Placed) and Manual Scleral Spur Annotation (Majority MSSA-Placed), Agreement Analysis Population Page 1 of 2 | Parameter Location | N | Limit of Agreement (LoA) | 95% CI of Lower Limit of LoA | 95% CI of Upper Limit of LoA | | --- | --- | --- | --- | --- | | SSA, * | | | | | | Open Angle Eye | | | | | | NSN | 19 | (-3.65, 8.60) | (-6.21, -1.09) | (6.04, 11.15) | | N | 25 | (-4.35, 6.35) | (-6.27, -2.44) | (4.44, 8.27) | | NIN | 24 | (-4.09, 7.34) | (-6.18, -2.00) | (5.25, 9.43) | | TIT | 25 | (-4.09, 6.65) | (-6.01, -2.17) | (4.73, 8.57) | | T | 25 | (-5.95, 6.11) | (-8.10, -3.79) | (3.95, 8.26) | | TST | 19 | (-5.85, 9.01) | (-8.96, -2.75) | (5.91, 12.11) | | Narrow Angle Eye | | | | | | NSN | 16 | (-7.05, 6.67) | (-10.21, -3.88) | (3.51, 9.84) | | N | 26 | (-3.18, 4.41) | (-4.51, -1.85) | (3.08, 5.74) | | NIN | 26 | (-6.31, 7.08) | (-8.65, -3.97) | (4.74, 9.42) | | TIT | 24 | (-6.70, 6.04) | (-9.03, -4.37) | (3.71, 8.37) | | T | 26 | (-7.60, 6.76) | (-10.12, -5.09) | (4.25, 9.27) | | TST | 16 | (-3.05, 4.80) | (-4.86, -1.24) | (2.99, 6.61) |  AOD, mm | Open Angle Eye | | | | | | --- | --- | --- | --- | --- | | NSN | 19 | (-0.08, 0.15) | (-0.12, -0.03) | (0.10, 0.20) | | N | 25 | (-0.06, 0.08) | (-0.08, -0.03) | (0.06, 0.11) | | NIN | 24 | (-0.06, 0.10) | (-0.09, -0.03) | (0.07, 0.13) | | TIT | 25 | (-0.08, 0.09) | (-0.11, -0.05) | (0.06, 0.12) | | T | 25 | (-0.13, 0.11) | (-0.18, -0.09) | (0.07, 0.16) | | TST | 19 | (-0.09, 0.12) | (-0.14, -0.05) | (0.07, 0.16) | | Narrow Angle Eye | | | | | | NSN | 16 | (-0.08, 0.07) | (-0.12, -0.05) | (0.04, 0.11) | | N | 26 | (-0.03, 0.04) | (-0.05, -0.02) | (0.03, 0.06) | | NIN | 26 | (-0.06, 0.06) | (-0.08, -0.04) | (0.04, 0.08) | | TIT | 24 | (-0.07, 0.06) | (-0.09, -0.05) | (0.03, 0.08) | | T | 26 | (-0.07, 0.06) | (-0.10, -0.05) | (0.04, 0.09) | | TST | 16 | (-0.02, 0.04) | (-0.04, -0.01) | (0.02, 0.05) |  SSA = Scleral Spur Angle, AOD = Angle Opening Distance, TISA = Trabecular-Iris Space Area STS = Spur-to-Spur Distance, LV = Lens Vault Location: S = Superior, N = Nasal, I = Inferior, T = Temporal 95% LoA = mean difference ± 2 × difference SD, 95% CI of LoA = LoA ± t(0.975, n-1) × Sqrt(n/3) × SD. N is the number of eyes with measurements from both ASSD and MSSA. There is one eye per subject, and each eye has one pair of measurements (first acceptable pairs). When the sample size is small, the estimates may not be reliable. Different N occurred between the various scleral spur locations or parameters if the scleral spur cannot be detected by the ASSD or cannot be annotated by the graders. Heidelberg Engineering GmbH K261019 Traditional 510(k): ANTERION Page 9 of 13 {13} Figure 2 Summary of Limit of Agreement for Measurements Between Automatic Scleral Spur Detection (ASSD-Placed) and Manual Scleral Spur Annotation (Majority MSSA-Placed), Agreement Analysis Population Page 2 of 2 | Parameter Location | N | Limit of Agreement (LoA) | 95% CI of Lower Limit of LoA | 95% CI of Upper Limit of LoA | | --- | --- | --- | --- | --- | | TISA, mm2 | | | | | | Open Angle Eye | | | | | | NSN | 17 | (-0.02, 0.04) | (-0.03, -0.01) | (0.03, 0.05) | | N | 23 | (-0.03, 0.04) | (-0.04, -0.02) | (0.03, 0.05) | | NIN | 19 | (-0.02, 0.03) | (-0.03, -0.01) | (0.02, 0.04) | | TIT | 23 | (-0.03, 0.03) | (-0.04, -0.02) | (0.02, 0.04) | | T | 24 | (-0.04, 0.03) | (-0.05, -0.03) | (0.02, 0.04) | | TST | 19 | (-0.03, 0.03) | (-0.04, -0.02) | (0.02, 0.05) | | Narrow Angle Eye | | | | | | NSN | 16 | (-0.04, 0.03) | (-0.05, -0.02) | (0.01, 0.04) | | N | 24 | (-0.01, 0.02) | (-0.02, -0.01) | (0.01, 0.02) | | NIN | 24 | (-0.02, 0.02) | (-0.03, -0.01) | (0.01, 0.03) | | TIT | 24 | (-0.03, 0.02) | (-0.04, -0.02) | (0.01, 0.03) | | T | 25 | (-0.03, 0.02) | (-0.03, -0.02) | (0.01, 0.03) | | TST | 15 | (-0.01, 0.01) | (-0.02, -0.01) | (0.01, 0.02) |  | STS, mm | | | | | | --- | --- | --- | --- | --- | | Open Angle Eye | | | | | | NSN to TIT | 19 | (-0.15, 0.03) | (-0.18, -0.11) | (-0.01, 0.07) | | N to T | 25 | (-0.11, 0.09) | (-0.15, -0.08) | (0.05, 0.12) | | NIN to TST | 18 | (-0.16, 0.08) | (-0.21, -0.11) | (0.03, 0.13) | | Narrow Angle Eye | | | | | | NSN to TIT | 15 | (-0.22, 0.14) | (-0.31, -0.13) | (0.05, 0.23) | | N to T | 26 | (-0.18, 0.14) | (-0.24, -0.13) | (0.08, 0.20) | | NIN to TST | 16 | (-0.19, 0.12) | (-0.26, -0.12) | (0.05, 0.19) |  | LV, mm | | | | | | --- | --- | --- | --- | --- | | Open Angle Eye | | | | | | NSN to TIT | 19 | (-0.04, 0.03) | (-0.06, -0.03) | (0.01, 0.04) | | N to T | 25 | (-0.04, 0.04) | (-0.05, -0.02) | (0.03, 0.06) | | NIN to TST | 18 | (-0.05, 0.04) | (-0.06, -0.03) | (0.02, 0.06) | | Narrow Angle Eye | | | | | | NSN to TIT | 15 | (-0.06, 0.05) | (-0.09, -0.04) | (0.03, 0.08) | | N to T | 25 | (-0.06, 0.06) | (-0.08, -0.04) | (0.04, 0.08) | | NIN to TST | 16 | (-0.06, 0.05) | (-0.08, -0.03) | (0.03, 0.08) |  SSA = Scleral Spur Angle, AOD = Angle Opening Distance, TISA = Trabecular-Iris Space Area STS = Spur-to-Spur Distance, LV = Lens Vault Location: S = Superior, N = Nasal, I = Inferior, T = Temporal 95% LoA = mean difference ± 2 × difference SD, 95% CI of LoA = LoA ± t(0.975, n-1) × Sqrt(n/3) × SD. N is the number of eyes with measurements from both ASSD and MSSA. There is one eye per subject, and each eye has one pair of measurements (first acceptable pairs). When the sample size is small, the estimates may not be reliable. Different N occurred between the various scleral spur locations or parameters if the scleral spur cannot be detected by the ASSD or cannot be annotated by the graders. Heidelberg Engineering GmbH K261019 Traditional 510(k): ANTERION Page 10 of 13 {14} Figure 3 Summary of Deming Regression for Measurements Between Automatic Scleral Spur Detection (ASSD-Placed) and Manual Scleral Spur Annotation (Majority MSSA-Placed), Agreement Analysis Population Page 1 of 2  SSA = Scleral Spur Angle, AOD = Angle Opening Distance, TISA = Trabecular-Iris Space Area STS = Spur-to-Spur Distance, LV = Lens Vault Location: S = Superior, N = Nasal, I = Inferior, T = Temporal N is the number of eyes with measurements from both ASSD and MSSA. There is one eye per subject, and each eye has one pair of measurements (first acceptable pairs). When the sample size is small, the estimates may not be reliable. Different N occurred between the various scleral spur locations or parameters if the scleral spur cannot be detected by the ASSD or cannot be annotated by the graders. Heidelberg Engineering GmbH K261019 Traditional 510(k): ANTERION Page 11 of 13 {15} Figure 3 Summary of Deming Regression for Measurements Between Automatic Scleral Spur Detection (ASSD-Placed) and Manual Scleral Spur Annotation (Majority MSSA-Placed), Agreement Analysis Population Page 2 of 2  SSA = Scleral Spur Angle, AOD = Angle Opening Distance, TISA = Trabecular-Iris Space Area STS = Spur-to-Spur Distance, LV = Lens Vault Location: S = Superior, N = Nasal, I = Inferior, T = Temporal N is the number of eyes with measurements from both ASSD and MSSA. There is one eye per subject, and each eye has one pair of measurements (first acceptable pairs). When the sample size is small, the estimates may not be reliable. Different N occurred between the various scleral spur locations or parameters if the scleral spur cannot be detected by the ASSD or cannot be annotated by the graders. Heidelberg Engineering GmbH K261019 Traditional 510(k): ANTERION Page 12 of 13 {16} # Overall Study Conclusion This study (B-2023-1) evaluated the precision and agreement of scleral spur related parameters obtained using automatic scleral spur detection (ASSD) in the ANTERION device with the Metrics App, where agreement was compared with manual scleral spur annotation (MSSA) performed by an independent reading center. The results demonstrated agreement between ASSD and MSSA, as well as repeatable and reproducible measurements obtained using ASSD. Based on the precision and agreement analysis findings, it can be concluded that the ANTERION with ASSD performs similarly to manual scleral spur detection for the evaluated parameters, supporting substantial equivalence for the investigational and legally marketed ANTERION devices. The results support that ASSD with user review and/or adjustment provides a practical and repeatable method to evaluate scleral spur-related parameters. # CONCLUSION The subject ANTERION (software version 1.5.2) has the same intended use, indications for use, and fundamental technological characteristics as its legally marketed predicate device (K240924). The software modifications described herein do not raise new or different questions of safety or effectiveness. Results of the clinical performance testing illustrate that measurements of the scleral spur-related parameters obtained from the modified ANTERION using automatic scleral spur detection are precise, and are similar to the measurements obtained from the legally marketed ANTERION devices using the manual annotation tools. Therefore, the study results support the substantial equivalence of the subject ANTERION and the predicate ANTERION (K240924) in regard to scleral spur-related parameter measurements. The non-clinical and clinical performance testing demonstrate that the device is as safe, as effective, and performs as well as the legally marketed predicate device. Heidelberg Engineering GmbH K261019 Traditional 510(k): ANTERION Page 13 of 13