Overjet Calculus Assist
Overjet Inc.Overjet Calculus Assist is a software tool that helps dentists detect calculus deposits on dental X-rays by automatically highlighting suspicious areas. It supports dentists in diagnosis by providing visual cues on bitewing and periapical radiographs, improving sensitivity to calculus without replacing clinical judgment.
Intended Use
Overjet Calculus Assist is a radiological automated concurrent-read computer-assisted detection software intended to aid in the detection of interproximal calculus deposits on both bitewing and periapical radiographs. It provides bounding boxes around suspected calculus deposits to assist dentists in diagnosis.
Technology
The software is a module within the Overjet Platform that analyzes bitewing and periapical dental radiographs. It processes images via a cloud-native three-layer architecture including network layer (image transmission), decision layer (image type validation and algorithmic annotation), and presentation layer (non-diagnostic viewer for annotations). It outputs bounding box outlines surrounding suspected calculus deposits for dentist review.
Performance
Performance testing included standalone verification on 618 dental radiographs with sensitivity ~74% and specificity ~99%. A multi-reader study showed improved dentist sensitivity with the software assistance (increase from ~75% to ~84% sensitivity) while specificity remained high. Statistically significant improvements in detection AUC were demonstrated in reader studies.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/31/2022
8 months - 2
FDA Approval
12/16/2022
Other devices from Overjet Inc.
- Overjet Image Enhancement Assist2024 • 510K
- Overjet Charting Assist2024 • 510K
- Overjet Caries Assist-Pediatric2024 • 510K
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