Overjet Charting Assist

K241684 · Overjet, Inc. · QIH · Aug 27, 2024 · Radiology

Device Facts

• Record ID: K241684
• Device Name: Overjet Charting Assist
• Applicant: Overjet, Inc.
• Product Code: QIH · Radiology
• Decision Date: Aug 27, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device, PCCP, Pediatric

Intended Use

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 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.

Device Story

Overjet Charting Assist is a software-based Medical Image Management and Processing System (MIMPS) used by dental professionals in clinical settings. It processes 2D dental radiographs (bitewing, periapical, panoramic) as input. The device utilizes machine learning algorithms to detect and segment natural tooth anatomy (enamel, pulp) and restorative dental structures (implants, crowns, root canals, fillings). The system outputs automated findings to assist clinicians in generating dental charts. The clinician reviews these outputs alongside patient history and clinical judgment to inform treatment decisions. The device is intended to improve charting accuracy and clinical documentation. It includes a Predetermined Change Control Plan (PCCP) for manual, non-automatic model updates based on real-world data to reduce false positives/negatives.

Clinical Evidence

No new clinical or performance testing was conducted. The device is identical to the predicate (K233590); existing data from the predicate submission remains applicable.

Technological Characteristics

Medical Image Management and Processing System (MIMPS). Software-based image analysis. ML-based detection of dental structures. PCCP included for manual, global model updates. No hardware components. Standalone software application.

Indications for Use

Indicated for dental professionals to assist in producing dental charts by detecting natural dental structures (enamel, pulp, tooth numbering) and restorative treatments (implants, crowns, endodontic treatment, fillings) on bitewing and periapical images for patients aged 5+ (primary/permanent teeth) and panoramic radiographs for patients with permanent teeth only.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• Overjet Charting Assist (K233590)

Submission Summary (Full Text)

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August 27, 2024

Overjet, Inc ೪% Deepthi Paknikar Associate Director of Regulatory and Clinical Affairs 50 Milk Street, 16th Floor BOSTON, MA 02109

Re: K241684

Trade/Device Name: Overjet Charting Assist Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QIH Dated: June 11, 2024 Received: August 7, 2024

Dear Deepthi Paknikar:

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.

FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP), "Predetermined Change Control Plan 'PCCP' for Overjet Charting Assist," Revision V1. 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

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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(0) 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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 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-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (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.

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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatory

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Lu Jiang

Lu Jiang, Ph.D. Assistant Director Diagnostic X-ray Systems Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

Submission Number (if known)

K241684

Device Name

Overjet Charting Assist

#### Indications for Use (Describe)

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 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).

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/4/Picture/0 description: The image contains the logo for Overjet. The logo consists of a stylized tooth icon on the left, followed by the text "OVERJET" in a sans-serif font. The tooth icon and the text are both in a light blue color. The logo appears to be for a dental or healthcare-related company.

### K241684 - 510 (k) Summary

Applicant Name: Overjet, Inc Applicant Address: 50 Milk Street 16th Floor Boston MA 02109 United States Applicant Contact Telephone: [phone] Applicant Contact: Dr. Deepthi Paknikar Applicant Contact Email: [e-mail] Correspondent Name: Overjet, Inc Correspondent Address: 50 Milk Street 16th Floor Boston MA 02109 United States Correspondent Contact Telephone: [phone] Correspondent Contact: Dr. Deepthi Paknikar Correspondent Contact Email: [e-mail] Date Prepared: August 8th, 2024

Device Trade Name: Overjet Charting Assist Common Name: Automated Radiological Image Processing System Classification Name: Medical image management and processing system Regulation Number: 892.2050 Product Code: QIH

Legally Marketed Predicate Device: Overjet Charting Assist Common Name: Automated Radiological Image Processing System Classification Name: Medical image management and processing system Regulation Number: 892.2050 Predicate Product Code: QIH Predicate K number: K233590

### Device Description Summary

Overjet Charting Assist is a Medical Image Management and Processing System (MIMPS) device aimed to assist dental professionals in detecting dental structures and producing dental charting data based on interpretation of 2D dental radiographs. The device is 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 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.

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# OVERJET

This device includes a Predetermined Change Control Plan (PCCP).

### Intended Use/Indications for Use

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 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).

### Indications for Use Comparison

The Overjet Charting Assist predicate device (K233590) and the subject Overjet Charting Assist Device are identical except that the subject device includes a Predetermined Change Control Plan (PCCP). There are no other differences between both devices, and the device features, incorporated models, indications for use, indicated patient population, and all other device aspects remained unchanged. The only difference between the predicate device and the subject device is the inclusion of a PCCP for the subject device.

### Technological Comparison

The only difference in technological characteristics between the subject and predicate devices is the inclusion of a Predetermined Change Control Plan (PCCP) for the subject device.

This PCCP outlines the process for evaluating and implementing modifications, specifically aimed at reducing false positives and false negatives based on real-world data. Modifications will be applied manually (non-automatically) across all devices. This approach ensures that any changes enhance the device's clinical utility and reliability while maintaining compliance with the original intended use and performance standards.

The PCCP includes a modification protocol that details the requirements for verification and validation activities supporting the proposed changes. The modification protocol incorporates impact assessment considerations and specifies detailed requirements for data management, including data sources, collection, documentation, and re-use practices. Specific requirements are in place for meeting performance criteria, and importantly, if a specific modification fails performance evaluation, the failure(s) will be documented as part of the Software Development Life Cycle (SDLC) process in the

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# N OVERJET

form of a controlled document (report), and the modification will not be implemented. A summary of the PCCP and modification protocol description is provided in the table below:

| PCCP Details | Description |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Modification Overview | Improve performance by reducing false positive<br>and false negative outputs based on post-market<br>and real-world data. Specifically, improvements<br>resulting from re-training the ML model with new<br>data. |
| Rationale | Aims to enhance clinical utility by improving the<br>device's accuracy, ensuring reliable data for<br>precise charting, and supporting high-quality<br>patient care and documentation. |
| Performance Evaluation Activity | Identical to the acceptance criteria and standalone<br>study protocol for the pre-modified version of the<br>device cleared in K233590. Primary endpoints<br>will be the main acceptance criteria, other<br>endpoints and additional analyses will be<br>conducted and reviewed for any major drop in<br>performance. |
| | If a specific modification fails performance<br>evaluation, failure(s) will be documented, and the<br>modification will not be implemented. |
| Implementation | The modification will be implemented manually<br>(non-automatic) across all devices on the market<br>in a uniform manner (global adaptation). |
| Impact on Indications/Intended Use | The modification will <b>not</b> affect the indications or<br>intended use of the Overjet Charting Assist<br>device, as cleared under K233590. |
| Release | The PCCP does not include any provisions for<br>implementation of adaptive algorithms that will<br>continuously learn in the field. In accordance with<br>the PCCP, all algorithm modifications will be<br>trained, tuned, and locked prior to release of the<br>software to the field. |
| Instructions for Use | A procedure for updating Instructions for Use<br>updates has been established in order to inform<br>users about algorithm changes implemented under<br>this FDA-authorized PCCP, including a summary |
| | of the changes and a characterization of algorithm<br>performance. Overjet will publish and<br>communicate the updated Instructions for Use<br>with customers. |

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Image /page/7/Picture/0 description: The image contains the logo for Overjet. The logo consists of a stylized tooth icon in blue, followed by the word "OVERJET" in a light blue sans-serif font. The tooth icon is abstract and appears to be made of multiple facets or planes.

### Non-Clinical and/or Clinical Tests Summary & Conclusions

Since the device remains unchanged from the Overjet Charting Assist Device cleared under K233590, no additional performance testing was conducted, and the existing data from the previous testing remains applicable.

Both the predicate device and the Overjet Charting Assist device share intended purpose. The subject and predicate devices are identical, with the only difference being a PCCP being included for the subject device. Despite minor technological differences, which is only the inclusion of a PCCP in this submission, these differences in technological features do not raise concerns regarding safety or effectiveness. The verification and validation testing and predefined Acceptance Criteria set for the standalone study are aligned with current dental practices and are deemed suitable for demonstrating that the Overjet Charting Assist functions according to specifications, meeting user needs and intended uses.

### Conclusion

Both the predicate device and the Overjet Charting Assist device share intended purpose. Despite minor technological differences, these differences in technological features do not raise concerns regarding safety or effectiveness. Following the information reviewed as part of this 510k, it can be concluded that the Overjet Charting Assist is substantially equivalent to the predicate device.