Overjet Charting Assist
Overjet, IncOverjet Charting Assist is an AI-powered medical image processing system that helps dental professionals detect and identify dental structures such as teeth anatomy and past restorative treatments on various dental radiographs. It assists in creating dental charts more efficiently by analyzing bitewing, periapical, and panoramic images, helping reduce manual charting efforts by over 80%.
Intended Use
Overjet Charting Assist is a Medical Image Management and Processing System (MIMPS) intended to detect natural dental structures including detection of tooth anatomy (enamel, pulp), and tooth numbering, as well as dental structures added through past restorative treatments: implants, crowns, endodontic treatment (previous root canal treatment), fillings. The device is intended to assist dental professionals in producing dental charts based on image analysis. The Overjet Charting Assist detects these findings on bitewing (BW) and periapical (PA) images for patients with primary and/or permanent teeth (Ages 5 and above), and panoramic (Pano) radiographs for patients with only permanent teeth. The device is not intended as a replacement for a complete clinician's review or clinical judgment that considers other relevant information from the image or patient history.
Technology
The device uses AI-based image analysis on 2D dental radiographs including bitewing, periapical, and panoramic images. It outputs semi-automatic segmented dental structures (tooth anatomy, restorative treatments, tooth numbering) with a user interface allowing users to show/hide, delete, and adjust findings. It functions as a cloud-based platform that assists dental professionals in generating dental charts based on detected findings.
Performance
The device underwent standalone performance evaluation on 634 images from 44 clinics across the U.S., covering diverse patient ages (5 and above) and image types (bitewing, periapical, panoramic). It demonstrated high sensitivity and specificity in detecting dental structures and restorative treatments, with sensitivity up to 95.9% for tooth anatomy and classification accuracy of 98.8% for tooth numbering. Manual charting operations were reduced by over 80% using the device. Testing also included verification, validation, and robustness studies across different sensor manufacturers.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/8/2023
3 months - 2
FDA Approval
2/23/2024
Other devices from Overjet, Inc
- Overjet Image Enhancement Assist2024 • 510K
- Overjet Charting Assist2024 • 510K
- Overjet Caries Assist-Pediatric2024 • 510K
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