Overjet Periapical Radiolucency Assist
Overjet, IncOverjet Periapical Radiolucency Assist is an AI-powered software designed to help dentists detect periapical radiolucencies in dental X-ray images, specifically on periapical radiographs. It provides automated, concurrent read assistance to improve diagnostic accuracy, supporting dentists in identifying potential issues in permanent teeth for patients aged 12 and older. The tool acts as a supplementary aid, enhancing clinical decision-making without replacing professional judgment.
Intended Use
Overjet Periapical Radiolucency (PARL) Assist is a radiological, automated, concurrent read computer-assisted detection software intended to aid in the detection of periapical radiolucencies on permanent teeth captured on periapical radiographs. The device provides additional aid for the dentist to use in their identification of periapical radiolucency. The device is not intended as a replacement for a complete dentist’s review or their clinical judgment that considers other relevant information from the image or patient history. The system is to be used by professionally trained and licensed dentists. The Overjet Periapical Radiolucency Assist software is indicated for use on patients 12 years of age or older.
Technology
The device operates as a software-only system within the Overjet Platform, using a multi-layer architecture including a Network Layer, Presentation Layer, and Decision Layer. It pulls images from dental clinics and uses a machine learning model to generate predictions displayed as segmented polygons of periapical radiolucency on periapical radiographs.
Performance
Performance was evaluated in a multi-reader multi-case (MRMC) study with 19 dentists assessing 379 periapical radiographs, demonstrating improved detection when using the device assist. Standalone testing on 763 images showed image-level sensitivity of 88% and specificity of 84.2%. Reader assistance improved artifact detection accuracy with statistically significant results (p < 0.001).
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/9/2023
3 months - 2
FDA Approval
9/21/2023
Other devices from Overjet, Inc
- Overjet Image Enhancement Assist2024 • 510K
- Overjet Charting Assist2024 • 510K
- Overjet Caries Assist-Pediatric2024 • 510K
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