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Intended 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 using a learning-based algorithm in bitewing and periapical images, and by enhancing contrast and sharpness via standard techniques for bitewing, periapical, and panoramic images. It is not intended to replace the clinic's own diagnostic imaging system.

Technology

The device is a Software as a Medical Device (SaMD) that enhances dental radiographic images within the Overjet Platform. It uses a learning-based algorithm for noise reduction on bitewing and periapical images and standard, non-learning based image enhancement techniques for contrast and sharpness. Panoramic images are enhanced via standard techniques only. AI predictions for dental findings run on original images only, ensuring no impact on diagnostic outputs by the enhancement feature.

Performance

Performance testing included software verification and validation, a retrospective study evaluating image quality improvements by quantifying contrast-to-noise ratio (CNR) and peak-signal-to-noise ratio (PSNR), and expert clinical evaluations. All tests passed successfully, demonstrating substantial equivalence to the predicate device.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    6/11/2024

    3 months
  • 2

    FDA Approval

    9/9/2024

Other devices from Overjet Inc

View all 9 devices

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