Overjet Multi-Image Caries and Charting Assist

{0} **FDA** U.S. FOOD & DRUG ADMINISTRATION August 6, 2026 Overjet, Inc. % Alireza Sojoudi V.P. of Machine Learning and Compliance 200 State St. Suite 1220 BOSTON, MA 02109 Re: K261059 Trade/Device Name: Overjet Multi-Image Caries and Charting Assist Regulation Number: 21 CFR 892.2070 Regulation Name: Medical Image Analyzer Regulatory Class: Class II Product Code: MYN Dated: July 2, 2026 Received: July 6, 2026 Dear Alireza Sojoudi: 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. {1} K261059 - Alireza Sojoudi Page 2 FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP). Under section 515C(b)(1) of the Act, a new premarket notification is not required for a change to a device cleared under section 510(k) of the Act, if such change is consistent with an established PCCP granted pursuant to section 515C(b)(2) of the Act. Under 21 CFR 807.81(a)(3), a new premarket notification is required if there is a major change or modification in the intended use of a device, or if there is a change or modification in a device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process. Accordingly, if deviations from the established PCCP result in a major change or modification in the intended use of the device, or result in a change or modification in the device that could significantly affect the safety or effectiveness of the device, then a new premarket notification would be required consistent with section 515C(b)(1) of the Act and 21 CFR 807.81(a)(3). Failure to submit such a premarket submission would constitute adulteration and misbranding under sections 501(f)(1)(B) and 502(o) of the Act, respectively. 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 {2} K261059 - Alireza Sojoudi Page 3 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). 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, Digitally signed by GABRIELA for M. RODAL -S Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products 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. | K261059 | ? | | Please provide the device trade name(s). | | ? | | Overjet Multi-Image Caries and Charting Assist | | | | Please provide your Indications for Use below. | | ? | | Overjet Multi-Image Caries and Charting Assist is a radiological, automated, concurrent-read, computer-assisted detection (CADe) software intended to aid in the detection and segmentation of caries (primary enamel, primary dentin and secondary) and in the detection of tooth anatomy (enamel, pulp), tooth numbering and dental structures added through past restorative treatments: implants, crowns, endodontic treatment, fillings.The device uses AI/ML algorithms to analyze all available dental radiographs of the patient jointly, evaluating findings at the patient-tooth level, to support the clinician's review. The device is not intended as a replacement for a complete dentist's review or their clinical judgment. The device is intended to detect caries on bitewing (BW) and periapical (PA) radiographs in patients 4 years of age and older, with visual differentiation between incipient caries, non-incipient caries and secondary caries. The device is intended to detect tooth anatomy, tooth numbering, and past restorative treatments on bitewing (BW) and periapical (PA) and panoramic (Pano) radiographs in patients 4 years of age and older. | | | | Please select the types of uses. | 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} K261059 OVERJET # 510(k) Summary This summary of 510(k) information is being submitted in accordance with the requirements of 21CFR Part 807.92 ## 1. Date March 31, 2026 ## 2. Applicant Overjet, Inc. 200 State St Suite 1220 Boston, MA 02109 Contact Person: Alireza Sojoudi Email: alireza.sojoudi@overjet.ai ## 3. Trade Name Overjet Multi-Image Caries and Charting Assist ## 4. Common Name Analyzer, Medical Image ## 5. Classification Regulation: 21 CFR 892.2070 Classification Name: Medical image analyzer Regulatory Class: Class II Product code: MYN Review Panel: Radiology ## 6. Device Description Overjet Multi-Image Caries and Charting Assist (OMICCA) is a radiological automated concurrent read computer assisted detection (CADe) software used in the detection and segmentation of primary caries (enamel and dentin) and secondary caries on bitewing and periapical radiographs. It is also used in the detection of tooth numbers and dental structures added through past restorations. The device provides additional information for the clinician to use in their diagnosis of a tooth surface suspected of being carious. The device is not intended as a replacement for a complete clinician's review or their clinical judgment that takes into account other relevant information from the image or patient history. {5} The difference between the subject device and the already cleared Overjet Caries Assist (OCA), Overjet Charting Assist (OChA) is that the subject device will be color-coding the caries sub-type (primary incipient, primary enamel and secondary) and it will use multiple patient-tooth level images jointly into the AI model as an input to aid in the detection of dental structures and suspected caries compared to a single image /radiograph used for image analyses in the other Overjet cleared devices. ## 7. Indications for Use Overjet Multi-Image Caries and Charting Assist is a radiological, automated, concurrent-read, computer-assisted detection (CADe) software intended to aid in the detection and segmentation of caries (primary enamel, primary dentin and secondary) and in the detection of tooth anatomy (enamel, pulp), tooth numbering and dental structures added through past restorative treatments: implants, crowns, endodontic treatment, fillings. The device uses AI/ML algorithms to analyze all available dental radiographs of the patient jointly, evaluating findings at the patient-tooth level, to support the clinician's review. The device is not intended as a replacement for a complete dentist's review or their clinical judgment. The device is intended to detect caries on bitewing (BW) and periapical (PA) radiographs in patients 4 years of age and older, with visual differentiation between incipient caries, non-incipient caries and secondary caries. The device is intended to detect tooth anatomy, tooth numbering, and past restorative treatments on bitewing (BW) and periapical (PA) and panoramic (Pano) radiographs in patients 4 years of age and older. ## 8. Predicate Device(s) | A. Device: | Overjet Caries Assist | | --- | --- | | Manufacturer: | Overjet, Inc. | | 510(k): | K222746 | | Product code: | MYN | | Common Name: | Analyzer, Medical Image | | Regulation: | 21 CFR 892.2070 | | Classification Name: | Medical image Analyzer | | B. Device: | Overjet Charting Assist | | Manufacturer: | Overjet, Inc. | | 510(k): | K241684 | | Product Code: | QIH | | Common Name: | Automated Radiological Image Processing System | | Regulation: | 21 CFR 892.2050 | | Classification Name: | Medical Image Management and Processing System | | C. Device: | Overjet Caries Assist - Pediatric | | Manufacturer: | Overjet, Inc. | | 510(k): | K233738 | | Product Code: | MYN | | Common Name: | Analyzer, Medical Image | | Regulation: | 21 CFR 892.2070 | | Classification Name: | Medical image Analyzer | {6} ## 9. Indications for Use Comparison: The subject device, Overjet Multi-Image Caries and Charting Assist (OMICCA), and the identified predicate devices share the same fundamental intended use: to assist dental professionals in the detection and visualization of clinical findings on 2D dental radiographs in order to support clinician review without replacing clinical judgement. The subject device differs from the predicate devices in that it expands functionality beyond caries detection and segmentation to additionally include annotating caries sub-types. Furthermore, the subject device supports analysis of one or more radiographs for certain detections, whereas the predicate devices are limited to single-image analysis. For charting detection in panoramic images, the subject device broadens the indicated patient population to include patients aged 4 and above, while the predicate is indicated for permanent dentition patients only. These differences reflect an expansion and consolidation of previously cleared functionalities and do not alter the fundamental intended use of the device. ## 10. Technological Characteristics Comparison | Criteria | Subject Device Overjet Multi-Image Caries and Charting Assist Overjet, Inc. | Primary Predicate Overjet Caries Assist Overjet, Inc. K222746 | Secondary Predicate Overjet Charting Assist Overjet, Inc. K241684 | Secondary Predicate Overjet Caries Assist - Pediatric Overjet, Inc K233738 | | --- | --- | --- | --- | --- | | Classification Regulation | 21 CFR 892.2070, Medical Image Analyzer | 21 CFR 892.2070, Medical Image Analyzer | 21 CFR 892.2050, Medical Image Management and Processing System | 21 CFR 892.2070, Medical Image Analyzer | | Intended Use/Indications for Use | Overjet Multi-Image Caries and Charting Assist (OMICCA) is a radiological, automated, concurrent-read, computer-assisted detection (CADe) software intended to aid in the detection and segmentation of caries (primary enamel, primary dentin and secondary) and in the detection of tooth anatomy (enamel, pulp), tooth numbering and dental structures added through past restorative treatments: implants, crowns, endodontic treatment, fillings. The device uses AI/ML algorithms to analyze one or more dental | Overjet Caries Assist (OCA) is a radiological, automated, concurrent-read, computer-assisted detection (CADe) software intended to aid in the detection and segmentation of caries on bitewing and periapical radiographs. The device provides additional information for the dentist to use in their diagnosis of a tooth surface suspected of being carious. The device is not intended as a replacement for a complete dentist's review or their clinical judgment that takes into account other relevant | Overjet Charting Assist is a Medical Image Management and Processing System (MIMPS) intended to detect natural dental structures including detection of tooth anatomy (enamel, pulp), and tooth numbering, as well as dental structures added through past restorative treatments: implants, crowns, endodontic treatment (previous root canal treatment), fillings. The device is intended to assist dental professionals in producing | Overjet Caries Assist-Pediatric (OCA-Ped) is a radiological, automated, concurrent-read, computer-assisted detection (CADe) software intended to aid in the detection and segmentation of caries on bitewing and periapical radiographs. The device provides additional information for the clinician to use in their diagnosis of a tooth surface suspected of being carious. The device is not intended as a replacement for a complete dentist's review or their clinical judgment that takes into account | {7} | Criteria | Subject Device Overjet Multi-Image Caries and Charting Assist Overjet, Inc. | Primary Predicate Overjet Caries Assist Overjet, Inc. K222746 | Secondary Predicate Overjet Charting Assist Overjet, Inc. K241684 | Secondary Predicate Overjet Caries Assist - Pediatric Overjet, Inc K233738 | | --- | --- | --- | --- | --- | | | radiographs to support the clinician's review. The device is not intended as a replacement for a complete dentist's review or their clinical judgment. The device is intended to detect caries on bitewing (BW) and periapical (PA) radiographs in patients 4 years of age and older, with visual differentiation between incipient caries, non-incipient caries and secondary caries. The device is intended to detect tooth anatomy, tooth numbering, and past restorative treatments on bitewing (BW) and periapical (PA) and panoramic (Pano) radiographs in patients 4 years of age and older. | information from the image, patient history, or actual in vivo clinical assessment. | dental charts based on image analysis. The Overjet Charting Assist detects these findings on bitewing (BW) and periapical (PA) images for patients with primary and/or permanent teeth (Ages 5 and above), and panoramic (Pano) radiographs for patients with only permanent teeth. The device is not intended as a replacement for a complete clinician's review or clinical judgment that considers other relevant information from the image or patient history. This device includes a Predetermined Change Control Plan (PCCP). | other relevant information from the image, patient history, or actual in vivo clinical assessment. The intended patient population of the device is patients aged 4-11 years old that have primary or permanent teeth (primary or mixed dentition) and are indicated for dental radiographs. | | Intended patient population | Caries Detection: Bitewing and Periapical Images - Ages 4 and above Charting: BW/PA/Pano -Ages 4 and above | BW/PA - Ages 12+ | BW/PA - Ages 5 and above Pano - Permanent dentition only | BW/PA - Ages 4-11 | | Imaging Modality | 2D intraoral or extraoral X-rays | 2D intraoral or extraoral X-rays | 2D intraoral or extraoral X-rays | 2D intraoral or extraoral X-rays | | Detection Types | Caries detection and segmentation resulting in color-coded outline or fill of suspected caries - primary incipient, primary dentin and secondary caries. Detecting and numbering teeth Detecting and identifying past restorative treatments | Caries detection and segmentation resulting in outline or fill of suspected caries | Detecting and numbering teeth Detecting and identifying past restorative treatments | Caries detection and segmentation resulting in outline or fill of suspected caries | {8} | Criteria | Subject Device Overjet Multi-Image Caries and Charting Assist Overjet, Inc. | Primary Predicate Overjet Caries Assist Overjet, Inc. K222746 | Secondary Predicate Overjet Charting Assist Overjet, Inc. K241684 | Secondary Predicate Overjet Caries Assist - Pediatric Overjet, Inc K233738 | | --- | --- | --- | --- | --- | | Technology | AI-based algorithms for the detection and segmentation. Uses a single (for anatomy) or **multiple image model** for analysis. | AI-based algorithms for the detection and segmentation. Uses a single image analysis model. | AI-based algorithms for the detection and numbering of teeth and past restorative treatments. Uses a single image analysis model. | AI-based algorithms for the detection and segmentation of suspected caries. Uses a single image analysis model. | The subject device OMICCA shares the same core technological characteristics as the predicate devices. All devices are software only, web-based applications that accept 2D dental radiographs imported from radiographic devices or practice management systems. All utilize AI-based algorithms to analyze radiographic images and present results as visual overlays on the original radiographs to support clinician interpretation. The differences between OMICCA and the predicate devices include: 1. Integration of caries and charting functionalities into a single device. 2. Use of multi-image AI input for caries detection, tooth numbering and prior restorations to evaluate findings at the patient-tooth level 3. Visual differentiation between incipient caries, non-incipient caries and secondary caries. These differences do not alter the fundamental scientific technology (AI-based radiographic image analysis), introduce new outputs or change the intended clinical workflow. Performance studies, including reader study and standalone performance study, demonstrates that the subject device performs as intended and does not raise any questions on the safety or efficacy of the device. ## 11. Performance Testing Overjet conducted comprehensive nonclinical performance testing to support a determination of substantial equivalence for Overjet Multi-Image Caries and Charting Assist (OMICCA). This included software verification and validation (V&V) testing in accordance with FDA guidance "General Principles of Software Validation" (FDA, January 2002) and the FDA-recognized consensus standard IEC 62304:2006+A1:2015 for software lifecycle processes. Testing encompassed unit-level validation, integration testing, system verification, and user acceptance testing, all of which confirmed that the software performs as intended under expected use conditions. Additionally, Overjet performed MRMC Reader Study and Standalone clinical performance studies (one for caries detection and one for dental charting) as described in the guidance documents "Computer-Assisted Detection Devices Applied to Radiology Images and {9} Radiology Device Data - Premarket Notification [510(k)] Submissions" and "Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification 510(k) Submissions". ## 11.1 MRMC Reader Study - Caries Overjet evaluated the Overjet Multi-Image Caries and Charting Assist (OMICCA) device in a multi reader multi case (MRMC) fully crossed reader improvement study. 23 US licensed dentists were asked to evaluate 1149 images from 500 patients. Roughly half the images had caries, and half without. Images were obtained from male and female patients aged 2-65+ years. The results were compared to the consensus reference standard established by 3 general dentists. Half of the data set contained unassisted images (raw images not run on the OMICCA device), and the second half contained radiographs that had been "assisted" or processed through the OMICCA device. The radiographs were presented to the readers in alternating groups. A 4-week washout period was utilized between two sessions to limit recollection bias. Following the washout, the readers were presented the same data set but with alternate grouping. The results were compared against a consensus ground truth, and the area under the curve (AUC) of the wAFROC was evaluated as a primary endpoint to characterize the performance of the readers assisted and unassisted by the OMICCA device. The AUC of the wAFROC averaged across all readers showed a 6.4% (0.0338, 0.0943) improvement in assisted readers compared to unassisted readers. The p-value was highly statistically significant. In addition, AUC of the wAFROC averaged across all readers showed an improvement of 15.24% (0.118, 0.1866) for enamel caries, 4.46% (0.0160, 0.073) for dentin caries and 11.48% (0.07667, 0.1528) for secondary caries all with highly statistically significant p-values. Average Tooth level sensitivity across all readers increased by 20.8% (0.147, 0.270) when compared to unassisted readers. The average tooth level specificity at the tooth level decreased by 3.8% between the assisted and unassisted readers. The results of the MRMC reader performance assessment demonstrates that readers assisted by the Overjet MICCA device improve in detection of caries when compared to unassisted readers. ## 11.2 Standalone Performance Testing - Caries Standalone performance of the Overjet Multi-Image Caries and Charting Assist device was evaluated for 1149 bitewing and periapical images. The dataset was split with roughly 50-50 images with and without caries, for patients aged 2-65+. Images were obtained from male and female patients, from a range of distinctly different geographic regions. The results were compared to the consensus reference standard established by 3 general dentists. {10} - Unique Patient-Tooth Level standalone sensitivity was 95.8%, with 95% CI's (0.945, 0.971) - Unique Patient-Tooth Level standalone specificity was 91.3%, with 95% CI's (0.903, 0.923) - Tooth Level standalone sensitivity was 91.6%, 95% CI's (0.898, 0.933) - Tooth Level standalone specificity was 92.9%, 95% CI's (0.920, 0.937) - Standalone Dice was a mean of 82.8%, 95% CI's (0.823, 0.834) ### 11.3 Standalone Performance Testing - Charting Standalone performance of the Overjet Multi-Image Charting Assist functionality was evaluated for 1588 images. Images were obtained from male and female patients with primary and permanent dentition, from various clinics across the U.S. The results were compared to a robust consensus reference standard established by trained dentists via majority pixel voting. Primary endpoints included tooth level sensitivity of past restorative treatment, dental tooth anatomy, and tooth level sensitivity (overall classification accuracy) of tooth numbering. Clinical sites were from across the U.S. and collected from 95 distinct clinics (for tooth numbering and past restoration images) and 66 clinics (for enamel and pulp). The following key results were obtained as a result of the standalone study, and the results demonstrate that the device performs well when compared to a robust reference standard. - Unique Patient-Tooth level standalone sensitivity of past restorative treatment was 91.0%, 95% CI (0.890, 0.927) - Unique Patient-Tooth level standalone specificity of past restorative treatment was 97.0%, 95% CI (0.965, 0.974) - Tooth Level standalone sensitivity of past restorative treatment was 90.8%, 95% CI's (0.892, 0.922) - Tooth Level standalone specificity for past restorative treatment was 97.3% (0.969, 0.977) - Tooth Level standalone sensitivity of dental tooth anatomy was 93.9%, 95% CI's (0.925, 0.952) - Tooth Level standalone sensitivity of tooth numbering was 95.2%, 95% CI's (0.939, 0.964) - Dice for Dental Tooth Anatomy resulted in a Mean Std. Dev. 0.816 (0.003) with 95% CI's (0.810, 0.822). - Dice for Past Restorative Structures resulted in a Mean Std. Dev. 0.904 (0.00) with 95% CI's (0.898, 0.910). - The Mean % Reduction per image in Manual Charting Operations with (95% CI) when using the OChA device is 78.47% (76.74%, 80.10%). In summary, all conducted tests produced results that exceeded predefined acceptance criteria. {11} ## 12. Predetermined Change Control Plan (PCCP) The 510(k) submission contains a Predetermined Change Control Plan (PCCP). Modifications to the algorithm of OVerjet Multi-Image Caries and Charting will be made in accordance with the guidelines outlined in the "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions". The PCCP describes the modifications that can occur in a controlled manner ensuring the continued safety, effectiveness and performance of the device. There are modifications outlined in the PCCP, and accordingly, any change will only occur after training, testing and validating the algorithm after which the change will be locked. When the modification is locked this will be communicated to all users through updated labelling via the Instructions for use. Verification and Validation activities will be conducted in accordance with the PCCP to compare the performance of the modified algorithms to the original model to ensure the safety and effectiveness. | **Modifications Summary** | | | --- | --- | | Description | Improve the performance of the OMICCA device by specifically improving on the rate of false positive and false negative outputs of the device based on post market and real world data. | | Rationale | Implementation of a Predetermined Change Control Plan (PCCP) focused on reducing false positives and false negatives is expected to enhance the clinical performance of the OMICCA device. Improved accuracy supports more reliable identification and characterization of caries, thereby providing clinicians with more dependable information for diagnostic assessment, charting, and clinical decision-making. | | Testing Methods | The performance evaluation of the device will be carried out per the Performance Study protocol provided in the 510(k) submission. If a specific modification fails performance evaluation, the failure(s) will be documented as part of the Software development life process (SDLC) and the modification will not be implemented. | | Update Procedures | A PCCP modification necessitates an adherence to the SDLC process. Therefore, the verification and validation testing will be carried out as part of the SDLC process. Further, prior to the PCCP modification being released, the User Manual and the | {12} | | software version will be updated to reflect the implemented changes. | | --- | --- | | Impact Assessment | The proposed modifications are intended to reduce false positive and false negative outputs, thereby improving the overall accuracy and reliability of the device. These improvements are expected to enhance clinical utility by supporting more consistent caries detection and charting, ultimately contributing to informed clinical decision-making. | ### 13. Conclusion Overjet Multi-Image Caries and Charting Assist (OMICCA) is substantially equivalent to the Overjet's predicate devices, Caries Assist, Charting Assist and Caries Assist- Pediatric. The differences do not raise any concerns about the safety or efficacy of the device.