Overjet Caries Assist-Pediatric
Overjet, IncOverjet Caries Assist-Pediatric is an AI-powered software designed to assist dentists by automatically detecting and outlining dental caries in bitewing and periapical radiographs of pediatric patients aged 4-11. It provides additional visual cues to support clinical diagnosis but is not a replacement for the dentist's comprehensive review and judgment.
Intended Use
Overjet Caries Assist-Pediatric 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 for patients aged 4-11 years.
Technology
The software operates through a three-layer architecture consisting of a Network Layer, Presentation Layer, and Decision Layer, using machine learning models to analyze input dental radiographs and output segmentations of suspected caries to a user dashboard.
Performance
Performance testing included a multi-reader multi-case (MRMC) study with 20 US dentists on 636 images and standalone testing on 1190 images. Assisted readers showed a 7.5% improvement in detection AUC over unassisted readers. Standalone sensitivity was 83.9% and specificity was 97.5% for caries detection.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/22/2023
3 months - 2
FDA Approval
3/4/2024
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