Overjet Image Enhancement Assist

K241681 · Overjet, Inc. · QIH · Sep 9, 2024 · Radiology

Device Facts

• Record ID: K241681
• Device Name: Overjet Image Enhancement Assist
• Applicant: Overjet, Inc.
• Product Code: QIH · Radiology
• Decision Date: Sep 9, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device, Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K241681 · Sep 9, 2024	Overjet Image Enhancement Assist	Overjet, Inc.	Retrospective dental radiographic images	Retrospective clinical images were used to perform a quantification report (CNR and PSNR metrics) and an expert clinical evaluation (Likert scale) to demonstrate the effectiveness of the image enhancement software.	Retrospective data; Image quality assessment; Clinical evaluation

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Retrospective image performance study; Retrospective performance evaluation	Dental radiographic images (bitewing, periapical, and panoramic)	Not applicable for this study	Contrast-to-noise ratio (CNR), peak-signal-to-noise ratio (PSNR), and expert clinical evaluation (Likert scale)

AI Performance

Output	Algorithm	Acceptance	Observed	Dev DS	Dev Readers	Test DS	Test Readers
Dental Radiograph Image Enhancement	Learning-based algorithm for noise reduction and standard non-learning techniques	—	—	—	—	Retrospective study: quantification report (CNR and PSNR) and Likert expert clinical evaluation.	>1 (expert readers)

Indications for Use

Overjet Image Enhancement Assist is an image processing software that can be used for image enhancement in dental radiographs viewed in the Overjet device platform. It is an optional tool to be used for image quality enhancement. The software improves image quality by: - Reducing Noise: Utilizing a learning-based algorithm for noise reduction in bitewing and periapical images. - Enhancing Contrast and Sharpness: Applying standard, non-learning based techniques to enhance contrast and sharpness for bitewing, periapical, and panoramic images. Raw images will be acquired and reviewed using the dental clinics standard imaging acquisition and viewing software. This device is part of the Overjet platform alone, it is not intended to replace their own diagnostic imaging system.

Device Story

Overjet Image Enhancement Assist is a SaMD tool for dental radiographs (bitewing, periapical, panoramic). It processes raw images acquired via standard clinic imaging systems. The device uses a learning-based algorithm for noise reduction (bitewing/periapical) and standard non-learning techniques for contrast/sharpness enhancement. Used by dental providers in clinics/hospitals within the Overjet platform; the enhancement feature is user-toggled. AI findings (caries, calculus) are processed on original, unenhanced images; enhancement does not modify other Overjet device outputs. Benefits include improved image quality for clinical review, aiding diagnostic visualization without replacing primary imaging systems.

Clinical Evidence

Bench testing only. Performance validated via software verification and validation testing. Retrospective study evaluated image quality using quantification metrics (CNR, PSNR) and expert clinical Likert evaluation. All tests passed, demonstrating substantial equivalence to the predicate.

Technological Characteristics

Software as a Medical Device (SaMD). Operates via web browser on the Overjet Platform. Uses PyTorch machine learning framework. Denoising via learning-based algorithm; contrast/sharpness enhancement via standard non-learning techniques. Loss functions include L1 and SSIM.

Indications for Use

Indicated for dental providers in clinics or hospitals to enhance the quality of dental radiographs (bitewing, periapical, and panoramic) viewed within the Overjet platform.

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

• SubtleMR (2.3.x) (K223623)

Submission Summary (Full Text)

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September 9, 2024

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

Re: K241681

Trade/Device Name: Overjet Image Enhancement 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 14, 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 (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/cdrb/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.

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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 (QS) 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.

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-device-advicecomprehensive-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-device-safety/medical-device-reportingmdr-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/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 Diagnostoc 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)

K241681

Device Name

Overjet Image Enhancement Assist

Indications for Use (Describe)

Overjet Image Enhancement Assist is an image processing software that can be used for image enhancement in dental radiographs viewed in the Overjet device platform. It is an optional tool to be used for image quality enhancement.

The software improves image qualitv by:

- Reducing Noise: Utilizing a learning-based algorithm for noise reduction in bitewing and periapical images.

- Enhancing Contrast and Sharpness: Applying standard, non-learning based techniques to enhance contrast and sharpness for bitewing, periapical, and panoramic images.

Raw images will be acquired and reviewed using the dental clinics standard imaging acquisition and viewing software. This device is part of the Overjet platform alone, it is not intended to replace their own diagnostic imaging system.

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.

#### K241681 - 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 15th, 2024

Device Trade Name: Overjet Image Enhancement 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: SubtleMR (2.3.x) Common Name: Automated Radiological Image Processing System Classification Name: Medical image management and processing system Regulation Number: 892.2050 Predicate Product Code: LLZ Predicate K number: K223623

#### Device Description Summary

Overjet Image Enhancement is a Software as a Medical Device (SaMD) that enhances dental radiographic images within the Overjet Platform, intended for use by dental providers in clinics or hospitals. It supports routine dental images, including bitewing, periapical, and panoramic images, viewed within the Overjet Platform.

The software enhances image quality by reducing noise with a learning-based algorithm for bitewing and periapical images, and by improving contrast and sharpness using standard, non-learning based techniques. For panoramic images, standard enhancement techniques improve contrast and sharpness without learning-based noise reduction. The enhancement feature can be toggled on and off by the user within the Overjet Platform. AI predictions for findings such as caries, calculus, etc. are run as specified for each FDA cleared device and are run on unenhanced (original) images only. There is no modification to the output of other FDA cleared Overjet devices when the image enhancement feature is applied.

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# OVERJET

### Intended Use/Indications for Use

Overjet Image Enhancement Assist is an image processing software that can be used for image enhancement in dental radiographs viewed in the Overjet device platform. It is an optional tool to be used for image quality enhancement.

The software improves image quality by:

- Reducing Noise: Utilizing a learning-based algorithm for noise reduction in bitewing and periapical images.

- Enhancing Contrast and Sharpness: Applying standard, non-learning based techniques to enhance contrast and sharpness for bitewing, periapical, and panoramic images.

Raw images will be acquired and reviewed using the dental clinics standard imaging acquisition and viewing software. This device is part of the Overjet platform alone, it is not intended to replace their own diagnostic imaging system.

### Indications for Use Comparison

The subject device is substantially equivalent to the predicate device. with minor differences. Both devices operate within standard imaging workflows, enhancing images for viewing. The subject device uses one model for denoising with standard techniques for sharpness and contrast, while the predicate uses two learning based models. Both devices utilize the PyTorch framework and similar loss functions, and these differences do not raise new questions of safety and effectiveness.

#### Technological Comparison

The technological characteristics of the subject device are nearly identical to those of the predicate device, with only minor differences. The subject device operates within the standard dental imaging workflow, allowing users to acquire, review, and store images as usual, with the enhanced images available for optional viewing on the Overjet Platform via a web browser. Unlike the predicate device, which uses two models for sharpness enhancement and denoising, the subject device employs a single model for denoising and standard techniques for sharpness and contrast. Both devices utilize the PyTorch machine learning framework and employ similar loss functions, including L1 and SSIM. These differences do not present new questions of safety and effectiveness, ensuring the subject device's substantial equivalence to the predicate.

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

Overjet conducted the following performance testing: software verification and validation testing, a study that utilized retrospective data to demonstrate that the software enhanced image quality (quantification report and expert clinical evaluation).

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# NOVERJET

The test methods were highly similar to those of the predicate device. The study on retrospective images was divided into two tests: 1) a quantification report to provide results on contrast-to-noise ratio (CNR) and peak-signal-to-noise ratio (PSNR), and 2) a Likert expert clinical evaluation. All tests passed successfully.

The results of this testing demonstrated that the performance of the Overjet Image Enhancement Assist device is substantially equivalent to that of the predicate device.