Overjet Caries Assist
Overjet, Inc.Overjet Caries Assist is an AI-powered software that helps dentists detect and segment dental caries (tooth decay) on bitewing and periapical X-ray images. It provides computer-generated annotations highlighting potential caries to support dentists' diagnosis, improving sensitivity in caries detection. It operates by processing dental radiographs using machine learning models and presenting annotated images in a viewer interface for the dentist. This assists dentists but does not replace professional judgment.
Intended Use
Overjet Caries Assist (OCA) is a radiological, automated, concurrent-read, computer-assisted detection (CADe) software intended to aid in the detection and segmentation of caries on bitewing and periapical radiographs. The device provides additional information for the dentist to use in their diagnosis of a tooth surface suspected of being carious. The device is not intended as a replacement for a complete dentist’s review or their clinical judgment that takes into account other relevant information from the image, patient history, or actual in vivo clinical assessment.
Technology
Overjet Caries Assist uses a machine learning system composed of three layers: Network Layer (handles image transmission from clinic systems), Decision Layer (processes images, classifies them as bitewing or periapical, segments carious lesions using an ensemble of segmentation models, and assigns lesions to teeth), and Presentation Layer (provides a non-diagnostic viewer for dentists to view, filter, and edit annotations). It utilizes image preprocessing, tooth number assignment, caries segmentation modules, and post-processing for lesion-to-tooth association.
Performance
Performance was tested via standalone and clinical reader studies. Standalone testing showed overall sensitivity of 76.6% (bitewing) and 79.4% (periapical) with specificity over 99%. Clinical reader studies involving 28 dentists demonstrated statistically significant improvements in sensitivity (increase from about 65% to 79%) and Dice scores when using the software, with only minor specificity decreases. The device was tested on multiple sensor manufacturers and images greater than 500x500 resolution.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/12/2022
6 months - 2
FDA Approval
3/27/2023
Other devices from Overjet, Inc.
- Overjet Image Enhancement Assist2024 • 510K
- Overjet Charting Assist2024 • 510K
- Overjet Caries Assist-Pediatric2024 • 510K
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