Second Opinion Periapical Radiolucency Contours
Pearl Inc.Second Opinion Periapical Radiolucency Contours is an AI-based computer-aided detection software that helps dentists identify areas of periapical radiolucency in dental X-rays by outlining suspected regions with polygonal contours. It supports dental professionals by providing a second opinion when reviewing periapical radiographs, potentially improving detection accuracy and aiding clinical decisions.
Intended Use
Second Opinion PC is a computer aided detection ("CADe") software to aid dentists in the detection of periapical radiolucencies by drawing bounding polygons to highlight the suspected region of interest. It is designed to aid dental health professionals to review periapical radiographs of permanent teeth in patients 12 years of age or older as a second reader.
Technology
Second Opinion PC consists of an API, Machine Learning Modules, and a Client User Interface. It uses neural network-based computer vision algorithms to detect periapical radiolucencies and marks them with polygonal contours on dental radiographs. The software runs on Windows OS and processes digital intraoral radiographs in a cloud-based environment.
Performance
Clinical performance was established by a non-inferiority standalone clinical study comparing polygonal detection results of Second Opinion PC with bounding box detections of a predicate device. The study used 500 images, and results showed Second Opinion PC was non-inferior with lesion level sensitivity of 77% and a false positive rate of 0.28 per image. The study used Weighted Alternative Free-Response Receiver Operating Characteristic (wAFROC) metrics for evaluation.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/30/2024
7 months - 2
FDA Approval
4/11/2025
Other devices from Pearl Inc.
- Second Opinion® CS2025 • 510K
- Second Opinion® 3D2025 • 510K
- Second Opinion® BLE2025 • 510K
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.