SPINEsim v1.0

{0} **U.S. FOOD & DRUG** ADMINISTRATION September 15, 2026 MDsim S.A. Dany Assaker VP Q&R, QMR, PRRC, DPO Av Des Hauts Fourneaux, 9 Esch-Sur-Alzette, 4362 Luxembourg Re: K261861 Trade/Device Name: SPINEsim v1.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QIH Dated: August 3, 2026 Received: August 6, 2026 Dear Dany Assaker: 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. 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" U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K261861 - Dany Assaker Page 2 (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. {2} K261861 - Dany Assaker Page 3 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). 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, Jessica Lamb, Ph.D. Assistant Director, Imaging Software Team DHT8B: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health 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. | K261861 | ? | | Please provide the device trade name(s). | | ? | | SPINEsim v1.0 | | | | Please provide your Indications for Use below. | | ? | | 1. Intended UseSPINEsim v1.0 is intended for assisting spine surgeons:• Visualizing and analyzing medical images.• Building a digital twin of the spine.• Computing spine parameters.• Using the digital twin and corresponding parameters to support clinical decision making.• Use the digital twin to plan spine surgery.• Comparing the simulated changes in parameters before and after various treatment options and between different treatment options.The device includes the semi-automatic analysis, landmarking and labelling of spine's anatomical bodies as seen in medical images, and the computation of parameters which include spino-pelvic parameters.Semi-automatic refers to the requested validation of the accuracy of the landmarking generated by our code by the user (spine surgeon).Clinical judgment and experience are required to properly use the software.1.1. Medical Conditions, Indications and ContraindicationsSPINEsim v1.0 is indicated when the patient has one of the following conditions (ICD-11 classification - ICD-11 for Mortality and Morbidity Statistics (who.int)):• Spinal deformities (FA70)o Kyphosis (FA70.0)o Scoliosis (FA70.1)o Lordosis (FA70.2)• Intervertebral disc degeneration (FA80)• Spondylolysis (FA81)• Spinal stenosis (FA82)• Spondylolisthesis (FA84)• Ankylosis of spinal joint (FB00)• Sacralisation of the last lumbar vertebra (LB73.26)• Lumbarisation of the first sacral vertebra (LB73.27)and that the patient condition can be improved by conservative treatment and/or a spine surgery aiming at correcting the spine alignment.Contraindications• Patient not accepting the application of SPINEsim v1.0 for planning his/her surgery.• Usage by non-trained clinicians.• Incomplete and/or non-consistent medical data used as input. | | | {4} • Medical images with inadequate formats, characteristics (e.g., field of views, pixel size, ...) or artefacts. • Patient with contraindications for fusion surgery. ### 1.2. Intended Patient Population SPINEsim v1.0 is applicable to the medical images of all patients independently of their gender, weight, height, BMI, ethnicity, skin type, nationality, habits (e.g. smoking). The age group for which SPINEsim v1.0 is to be used is limited to adults (22 years old and greater). | 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) | ? | {5} MDsim Product Excellence K261861 FDA 510(K) Summary # FDA 510(K) Summary of SPINEsim v1.0. I. SUBMITTER: MDsim S.A. 9, Av des Hauts Fourneaux 4362 Esch-sur-Alzette Luxembourg https://mdsim.health MDsim Establishment Registration Number: LU34471821 (Identification), 2022 2204 381 Contact Person: Dr Dany Assaker, PhD, eMBA VP Q&R, PRRC dany.assaker@mdsim.health +352 691 91 3695 Date of Summary: Sept 12, 2026 II. DEVICE Subject: 510(k) Premarket Notification Submission | **510(k) Number:** | K261861 | | --- | --- | | **Submission Type:** | Traditional 510(k) | | **Reason for the 510(k):** | New device | | **Common Name:** | SPINEsim v1.0 | | **Trade Name / Proprietary Name:** | SPINEsim v1.0 | | **Classification Name:** | Automated Radiological Image Processing Software | | **Product Code:** | QIH | | **Regulation Number:** | 892.2050 (automated radiological image processing software) | | **Classification:** | Class II | FDA 510(K) Summary revised V6.docx 01_00_002_General Template Word Portrait format_V02 Printed version is not subject to change management. Always use the up-to-date document. Page 1 of 10 {6} MDsim Predict Excellence FDA 510(K) Summary ### III. PREDICATE DEVICE | **Predicate device:** | Surgimap 2.0 | | --- | --- | | **510(k) Number:** | K141669 | | **Classification Name:** | System, image processing, radiological | | **Product Code:** | LLZ | | **Classification:** | Class II | ### IV. DEVICE DESCRIPTION SPINEsim v1.0 is a Software as a Medical Device (SaMD) developed by MDsim S.A. to assist Spine Surgeons in generating a digital twin of the spine that can be used to visualize the patient's spine data, compute key spine parameters and, if needed, to plan spine surgery. It is a web application and can be used at hospital and/or home. The device includes an initial AI proposal for landmarking and labeling of the spine medical DX/CR images. SPINEsim v1.0 requests adjustment and validation by the spine surgeon of the proposed image analysis before computing the spino-pelvic parameters, the Hounsfield units, and the spine shape changes between supine and standup positions. It also assists the surgeon in simulating the effect of surgical acts like osteotomies, interbody cages, and vertebral reduction. Clinical judgment and spine surgery experience are required to properly use the software to support decision making. ### V. INTENDED USE and INDICATIONS FOR USE #### 1. Intended Use SPINEsim v1.0 is intended for assisting spine surgeons: - Visualizing and analyzing medical images. - Building a digital twin of the spine. - Computing spine parameters. - Using the digital twin and corresponding parameters to support clinical decision making. - Use the digital twin to plan spine surgery. - Comparing the simulated changes in parameters before and after various treatment options and between different treatment options. FDA 510(K) Summary revised V6.docx 01_00_002_General Template Word Portrait format_V02 Printed version is not subject to change management. Always use the up-to-date document. Page 2 of 10 {7} MDsim Predict Excellence FDA 510(K) Summary The device includes the semi-automatic analysis, landmarking and labelling of spine's anatomical bodies as seen in medical images, and the computation of parameters which include spino-pelvic parameters. Semi-automatic refers to the requested validation of the accuracy of the landmarking generated by our code by the user (spine surgeon). Clinical judgment and experience are required to properly use the software. ### 1.1. Medical Conditions, Indications and Contraindications SPINEsim v1.0 is indicated when the patient has one of the following conditions (ICD-11 classification - ICD-11 for Mortality and Morbidity Statistics (who.int)): - Spinal deformities (FA70) - Kyphosis (FA70.0) - Scoliosis (FA70.1) - Lordosis (FA70.2) - Intervertebral disc degeneration (FA80) - Spondylolysis (FA81) - Spinal stenosis (FA82) - Spondylolisthesis (FA84) - Ankylosis of spinal joint (FB00) - Sacralisation of the last lumbar vertebra (LB73.26) - Lumbarisation of the first sacral vertebra (LB73.27) and that the patient condition can be improved by conservative treatment and/or a spine surgery aiming at correcting the spine alignment. Contraindications - Patient not accepting the application of SPINEsim v1.0 for planning his/her surgery. - Usage by non-trained clinicians. - Incomplete and/or non-consistent medical data used as input. - Medical images with inadequate formats, characteristics (e.g., field of views, pixel size, ...) or artefacts. - Patient with contraindications for fusion surgery. ### 1.2. Intended Patient Population SPINEsim v1.0 is applicable to the medical images of all patients independently of their gender, weight, height, BMI, ethnicity, skin type, nationality, habits (e.g. smoking). The age group for which SPINEsim v1.0 is to be used is limited to adults (22 years old and greater). FDA 510(K) Summary revised V6.docx 01_00_002_General Template Word Portrait format_V02 Printed version is not subject to change management. Always use the up-to-date document. Page 3 of 10 {8} MDsim Predict Excellence FDA 510(K) Summary # VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE Both SPINEsim v1.0 and Surgimap 2.0 share the same intended use and technological characteristics. | | Subject Device: SPINEsim v1.0 | Primary Predicate: Surgimap 2.0 | Substantially equivalent? | | --- | --- | --- | --- | | **Manufacturer** | MDsim | Nemaris Inc. | - | | **510(k) number** | K261861 | K141669 | - | | **Device Class** | II | II | **YES** | | **Product Code(s)** | QIH (automated radiological image processing software) | LLZ (System, Image Processing, Radiological) | **YES** K141669 is used as the predicate since QIH and LLZ are both product codes under 21 CFR 892.2050 | | **Regulation Description** | Medical Image Management and Processing System (MIMPS) | Picture Archiving and Communication System (PACS) | **YES** Both devices are classified under 21 CFR 892.2050. | | **Regulation Number** | 21 CFR §892.2050 | 21 CFR §892.2050 | **YES** | | **Operating System** | Windows + MAC | Windows + MAC | **YES** | | **Software Environment** | Cloud-based software | Standalone application with a feature of cloud synchronization | **YES** SPINEsim v1.0 is not a standalone software as **Surgimap 2.0**. However, it does not impact the **intended use** and its **substantial equivalence** to the predicate device. | | **Input Data** | Medical images **X-Rays** (standard or EOS), **CT, MRI**. (DICOM or NIFTI) General purpose images (like in .png, .jpg, .jpeg, .bmp, .heic formats) Information about the patient (name, age, gender). | MRI, CT, X-Rays (DICOM) Standard image formats (jpeg, tiff, png) | **YES** SPINEsim v1.0 includes the use of NIFTI format compared to Surgimap 2.0. | | **Obtaining Images** | Local | Local + PACS connectivity | **YES** | FDA 510(K) Summary revised V6.docx 01_00_002_General Template Word Portrait format_V02 Printed version is not subject to change management. Always use the up-to-date document. Page 4 of 10 {9} MOSim Predict Excellence FDA 510(K) Summary | | | | SPINEsim v1.0 is not connected to PACS as **Surgimap 2.0**. However, this reduction in functionality does not impact the **intended use** and its **substantial equivalence** to the predicate device. | | --- | --- | --- | --- | | **Image Manipulation Functions** | Medical images display and basic manipulation (e.g., zooming, brightness, contrast, resetting view, capturing screenshot) | Medical images display and basic manipulation (e.g., zooming, invert black/white, brightness, gamma, contrast, max contrast, auto level image, rotate 90 Degrees, Individual Degree Rotation, flip vertically/ horizontally, fit to screen, resetting view, show/hide minimap, show/hide text overlay, show/hide scout lines, show/hide measurements, show original image, opacity, measurement rollback, modify layout) | **YES** | | **Generic Measurements** | Distances, angles | Distances using line, pencil and multi-line, angles, area using circles, ellipses, quad, and back surface metrics | **YES** Surgimap 2.0 offers additional instruments for generic measurements; however, this reduction in functionality does not impact the **intended use** and its **substantial equivalence** to the predicate device. | | **Geometric Anatomical Measurements** | Spine Measurements Lower Limb Measurements | Spine Measurements Lower Limb Measurements | **YES** | | **3D Bone Visualization** | Bone Density Relative Mapping and 3D image reconstruction | Conventional 3D ray-casting | **YES** **Surgimap 2.0** provides similar tool | | **Software Functionalities** | **Automatically computes landmarks** associated with vertebral endplates, pelvis and lower limbs needed to calculate coronal and sagittal clinical parameters. These | Landmarks associated with vertebral endplates and pelvis are **manually added**. | **YES** **Surgimap 2.0** allows to obtain landmarks based on the clinician input. In **SPINEsim v1.0**, since the automatically | FDA 510(K) Summary revised V6.docx 01_00_002_General Template Word Portrait format_V02 Printed version is not subject to change management. Always use the up-to-date document. Page 5 of 10 {10} MOSim Product Excellence FDA 510(K) Summary | | landmarks are **adjustable by the user**. | | generated landmarks **must be validated by the clinician**, this difference **does not impact the intended use** and its **substantial equivalence** to the predicate device. | | --- | --- | --- | --- | | | Patient-specific clinical parameters and calculations based on published literature. | Patient-specific clinical parameters and calculations based on published literature. | **YES** | | | Display a target spine shape and parameters (SAAS/GAP guidelines) based on published literature | Display a target spine shape (SAAS rule) based on published literature | **YES** | | **Surgical Tools** | **Osteotomies** (up to grade IV), applying **image morphing** on the removed part. **Instrumentation** (screw, cages & rod placement) | **Osteotomies** (open, close, wedge), showing a black area on the removed part. **Instrumentation** (screws, cages & rod placement) | **YES** Applying image morphing instead of displaying a black area on the removed part does not impact its substantial equivalence to the predicate device. | | **Database (list of implants) /templating** | Generic implants (screws, rod and cages) | Generic implants and vendor specific implant | **YES** **SPINEsim v1.0** only provides generic implants and it does not include a list of vendor implants as **Surgimap 2.0**. | | **Human intervention for interpretation and manipulation of images** | Required | Required | **YES** | | **Control of life-saving devices** | None | None | **YES** | | **Case sharing** | No | Yes | **YES** **SPINEsim v1.0** does not support case sharing as **Surgimap 2.0**. However, this reduction in functionality | FDA 510(K) Summary revised V6.docx 01_00_002_General Template Word Portrait format_V02 Printed version is not subject to change management. Always use the up-to-date document. Page 6 of 10 {11} MOSim Predict Excellence FDA 510(K) Summary | | | | does not impact the **intended use** and its **substantial equivalence** to the predicate device. | | --- | --- | --- | --- | | **Indication for use** | **1. Intended Use** SPINEsim v1.0 is intended for assisting spine surgeons: • Visualizing and analyzing medical images. • Building a digital twin of the spine. • Computing spine parameters. • Using the digital twin and corresponding parameters to support clinical decision making; • Use the digital twin to plan spine surgery. • Comparing the simulated changes in parameters before and after various treatment options and between different treatment options. The device includes the semi-automatic analysis, landmarking and labelling of spine's anatomical bodies as seen in medical images, and the computation of parameters which include spino-pelvic parameters. Semi-automatic refers to the requested validation of the accuracy of the landmarking generated by our code by the user (spine surgeon). Clinical judgment and experience are required to properly use the software. **1.1. Medical Conditions, Indications and Contraindications** SPINEsim v1.0 is indicated when the patient has one of the following conditions (ICD-11 classification - ICD-11 for Mortality and Morbidity Statistics (who.int)): • Spinal deformities (FA70) o Kyphosis (FA70.0) o Scoliosis (FA70.1) | The Surgimap software assists healthcare professionals in viewing, storing, and measuring images as well as planning orthopedic surgeries. The device allows service providers to perform generic as well as specialty measurements of the images, and to plan surgical procedures. The device also includes tools for measuring anatomical components for placement of surgical implants, and offer online synchronization of the database with the possibility to share data among Surgimap users. Clinical judgment and experience are required to properly use the software. | **YES** SPINEsim v1.0 and Surgimap 2.0 have the same general purpose. Surgimap 2.0 describes this purpose broadly for orthopedic surgeries, whereas SPINEsim v1.0 provides a more specific application for spine surgeons, including defined medical conditions, indications, and intended patient population. This additional specificity narrows the intended clinical scope and does not introduce a new intended use or raise different questions of safety and effectiveness. | FDA 510(K) Summary revised V6.docx 01_00_002_General Template Word Portrait format_V02 Printed version is not subject to change management. Always use the up-to-date document. Page 7 of 10 {12} MDsim Product Excellence FDA 510(K) Summary | | o Lordosis (FA70.2) • Intervertebral disc degeneration (FA80) • Spondylolysis (FA81) • Spinal stenosis (FA82) • Spondylolisthesis (FA84) • Ankylosis of spinal joint (FB00) • Sacralisation of the last lumbar vertebra (LB73.26) • Lumbarisation of the first sacral vertebra (LB73.27) and that the patient condition can be improved by conservative treatment and/or a spine surgery aiming at correcting the spine alignment. **Contraindications** • Patient not accepting the application of SPINEsim v1.0 for planning his/her surgery. • Usage by non-trained clinicians. • Incomplete and/or non-consistent medical data used as input. • Medical images with inadequate formats, characteristics (e.g., field of views, pixel size, ...) or artefacts. • Patient with contraindications for fusion surgery. **1.2. Intended Patient Population** SPINEsim v1.0 is applicable to the medical images of all patients independently of their gender, weight, height, BMI, ethnicity, skin type, nationality, habits (e.g. smoking). The age group for which SPINEsim v1.0 is to be used is limited to adults (22 years old and greater). | | | | --- | --- | --- | --- | FDA 510(K) Summary revised V6.docx 01_00_002_General Template Word Portrait format_V02 Printed version is not subject to change management. Always use the up-to-date document. Page 8 of 10 {13} MDsim Predict Excellence FDA 510(K) Summary Differences between SPINEsim v1.0 and Surgimap 2.0 are listed in the table below: | | SPINEsim v1.0 | Surgimap 2.0 | Impact on predicate strategy? | | --- | --- | --- | --- | | Software environment | Cloud-based | Local | No | | Connectivity | None | PACS | No | | Input format | DICOM or NIFTI, .jpg, .png, .jpeg, .bmp, .heic | DICOM, .jpg, .tiff, .png | No | | Generic management and image manipulation tools | Reduced | Extended | No | | Implants database | Generic only | Specific implants from providers | No | | Landmarking and labeling | Semi-automatic with AI | Manual | No | ## VII. PERFORMANCE DATA Nonclinical performance testing was conducted on SPINEsim v1.0 to support substantial equivalence to Surgimap 2.0. Testing included software verification and validation, AI model verification and validation, human factor engineering testing, and cybersecurity testing. ### Software verification and Validation Software verification confirmed implementation of the specified software requirements through unit, integration, system, and functional testing. Testing covered the principal workflows and functions, including image import and manipulation, measurements, landmark review and validation, computation of spinopelvic parameters, surgical planning, report generation, data handling, and user authentication. Model verification and validation addressed the AI landmarking model and the numerical models used for parameter calculation, surgical simulation, radiodensity analysis, medical-image processing, and anatomical sanity checks ### AI Landmarking Performance The AI-based landmarking function represents a technological difference from the predicate device, in which landmarks are placed manually. SPINEsim v1.0 provides an initial landmark proposal that must be reviewed, adjusted where necessary, and validated by the spine surgeon before subsequent calculations or simulations are performed. Algorithm performance was evaluated using dedicated lateral and frontal DX/EOS test datasets that were independent of the data used for model training and development. The test datasets included 123 lateral cases and 129 frontal cases. Reference landmark positions were established from annotations performed by three qualified clinical experts, with the median expert position used as the reference annotation. FDA 510(K) Summary revised V6.docx 01_00_002_General Template Word Portrait format_V02 Printed version is not subject to change management. Always use the up-to-date document. Page 9 of 10 {14} MDsim Predict Excellence FDA 510(K) Summary For each landmark, the Euclidean distance between the AI-generated position and the reference position was calculated. Performance was assessed using Mean Distance Error (MDE), median error, accuracy, precision, recall, and F1 score. The predefined acceptance criteria were an MDE of no more than 10 mm for vertebral landmarks and no more than 22 mm for other skeletal landmarks. All landmarking results met the predefined acceptance criteria. ### Human Factor Engineering and Cybersecurity Validation Various Formative testing sessions were conducted with representative spine surgeons. Participants performed representative workflows covering patient selection, image upload, Digital Twin creation, review and correction of AI-generated landmarks, measurements, surgical planning, report generation, and interpretation of warnings. The evaluation addressed all use-related risks and identified no new use-related risks. Additionally, Summative usability testing was conducted with 15 representative spine surgeons following training. These tests reinforced confidence in the risk-free and user friendliness of the User Interface. Cybersecurity testing included security scanning, software component and dependency assessment, Software Bill of Materials generation, and web-application security testing. The cybersecurity and penetration-testing activities met their applicable acceptance criteria. The following guidelines and standards were used throughout the software development process: | ASME V&V 40-2018 | Assessing Credibility of Computational Modeling Through Verification and Validation: Application to Medical Devices | | --- | --- | | IEC 62304:2006 | Medical device software - Software life cycle processes | | IEC 62366-1:2015 +A1:2020 | Part 1: Application of usability engineering to medical devices | | FDA-2021-D-0980 | Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions | ### VIII. CONCLUSION The evidence from verification and validation results demonstrates that SPINEsim v1.0 accurately and reliably performs its intended software functions. These results address the technological differences between SPINEsim v1.0 and Surgimap 2.0 and demonstrate that the differences do not raise different questions of safety or effectiveness. The performance data support the conclusion that SPINEsim v1.0 is substantially equivalent to the predicate device. FDA 510(K) Summary revised V6.docx 01_00_002_General Template Word Portrait format_V02 Printed version is not subject to change management. Always use the up-to-date document. Page 10 of 10