(77 days)
Not Found
Yes
The text explicitly mentions "re-training the ML model with new data," indicating the use of Machine Learning.
No
The device is described as a Medical Image Management and Processing System (MIMPS) intended to assist dental professionals in detecting dental structures and creating dental charts. It does not exert any direct therapeutic action on the patient.
No
The device is intended to assist dental professionals in producing dental charts based on image analysis, and is not intended as a replacement for a complete clinician's review or clinical judgment. It helps detect structures but leaves the final diagnosis to the human professional.
Yes
The device is described as a "Medical Image Management and Processing System (MIMPS)" that processes 2D dental radiographs. The description focuses entirely on the software's function of detecting dental structures and assisting in charting based on image analysis. There is no mention of any accompanying hardware component being part of the device itself. The input is existing image data, and the output is charting data based on the software's analysis.
Based on the provided information, the Overjet Charting Assist is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Overjet Charting Assist Function: The Overjet Charting Assist processes and analyzes medical images (dental radiographs). It does not perform tests on biological samples.
- Intended Use: The intended use clearly states it's a "Medical Image Management and Processing System (MIMPS)" intended to assist dental professionals in producing dental charts based on image analysis.
Therefore, while it is a medical device that uses AI/ML and image processing, its function and intended use fall outside the scope of an In Vitro Diagnostic device.
Yes
The letter explicitly states, "FDA's substantial equivalence determination also included the review and clearance of your 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.
Product codes (comma separated list FDA assigned to the subject device)
QIH
Device Description
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
bitewing (BW), periapical (PA) images, panoramic (Pano) radiographs
Anatomical Site
Not Found
Indicated Patient Age Range
Ages 5 and above for patients with primary and/or permanent teeth (for bitewing and periapical images); only permanent teeth (for panoramic radiographs).
Intended User / Care Setting
dental professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
This device includes a Predetermined Change Control Plan (PCCP).
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.
The 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 form of a controlled document (report), and the modification will not be implemented.
PCCP Details:
- Modification Overview: Improve performance by reducing false positive and false negative outputs based on post-market and real-world data. Specifically, improvements resulting from re-training the ML model with new data.
- Rationale: Aims to enhance clinical utility by improving the device's accuracy, ensuring reliable data for precise charting, and supporting high-quality patient care and documentation.
- Performance Evaluation Activity: Identical to the acceptance criteria and standalone study protocol for the pre-modified version of the device cleared in K233590. Primary endpoints will be the main acceptance criteria, other endpoints and additional analyses will be conducted and reviewed for any major drop in performance. If a specific modification fails performance evaluation, failure(s) will be documented, and the modification will not be implemented.
- Implementation: The modification will be implemented manually (non-automatic) across all devices on the market in a uniform manner (global adaptation).
- Impact on Indications/Intended Use: The modification will not affect the indications or intended use of the Overjet Charting Assist device, as cleared under K233590.
- Release: The PCCP does not include any provisions for implementation of adaptive algorithms that will continuously learn in the field. In accordance with the PCCP, all algorithm modifications will be trained, tuned, and locked prior to release of the software to the field.
- Instructions for Use: A procedure for updating Instructions for Use updates has been established in order to inform users about algorithm changes implemented under this FDA-authorized PCCP, including a summary of the changes and a characterization of algorithm performance. Overjet will publish and communicate the updated Instructions for Use with customers.
§ 892.2050 Medical image management and processing system.
(a)
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.(b)
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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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
2
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,
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
3
Indications for Use
Submission Number (if known)
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: 630-201-1612 Applicant Contact: Dr. Deepthi Paknikar Applicant Contact Email: deepthi.paknikar@overjet.ai Correspondent Name: Overjet, Inc Correspondent Address: 50 Milk Street 16th Floor Boston MA 02109 United States Correspondent Contact Telephone: 630-201-1612 Correspondent Contact: Dr. Deepthi Paknikar Correspondent Contact Email: deepthi.paknikar@overjet.ai 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.
5
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
6
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 |
| and false negative outputs based on post-market | |
| and real-world data. Specifically, improvements | |
| resulting from re-training the ML model with new | |
| data. | |
| Rationale | Aims to enhance clinical utility by improving the |
| device's accuracy, ensuring reliable data for | |
| precise charting, and supporting high-quality | |
| patient care and documentation. | |
| Performance Evaluation Activity | Identical to the acceptance criteria and standalone |
| study protocol for the pre-modified version of the | |
| device cleared in K233590. Primary endpoints | |
| will be the main acceptance criteria, other | |
| endpoints and additional analyses will be | |
| conducted and reviewed for any major drop in | |
| performance. | |
| If a specific modification fails performance | |
| evaluation, failure(s) will be documented, and the | |
| modification will not be implemented. | |
| Implementation | The modification will be implemented manually |
| (non-automatic) across all devices on the market | |
| in a uniform manner (global adaptation). | |
| Impact on Indications/Intended Use | The modification will not affect the indications or |
| intended use of the Overjet Charting Assist | |
| device, as cleared under K233590. | |
| Release | The PCCP does not include any provisions for |
| implementation of adaptive algorithms that will | |
| continuously learn in the field. In accordance with | |
| the PCCP, all algorithm modifications will be | |
| trained, tuned, and locked prior to release of the | |
| software to the field. | |
| Instructions for Use | A procedure for updating Instructions for Use |
| updates has been established in order to inform | |
| users about algorithm changes implemented under | |
| this FDA-authorized PCCP, including a summary | |
| of the changes and a characterization of algorithm | |
| performance. Overjet will publish and | |
| communicate the updated Instructions for Use | |
| 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.