Search Results

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.

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.

The provided text describes the Overjet Image Enhancement Assist device and its substantial equivalence determination by the FDA. While it states that "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)," and mentions "All tests passed successfully," it does not provide the specific acceptance criteria or the detailed results of the study that proves the device meets those criteria.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts and their qualifications for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study results.
6. Standalone performance results.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document only states the types of tests performed (quantification report for CNR and PSNR, and a Likert expert clinical evaluation) and that "All tests passed successfully," implying that the device met internal, but not explicitly stated, acceptance criteria. It also mentions that the "test methods were highly similar to those of the predicate device."

Ask a specific question about this device