Second Opinion
Pearl Inc.Second Opinion is an AI-based software designed to assist dental professionals by automatically detecting and highlighting potential dental issues, such as caries and restorations, on bitewing and periapical radiographs. It acts as a second reader, improving diagnostic accuracy and helping clinicians identify abnormalities more effectively.
Intended Use
Second Opinion® is a computer aided detection ("CADe") software to identify and mark regions in relation to suspected dental findings which include Caries, Discrepancy at the margin of an existing restoration, Calculus, Periapical radiolucency, Crown (metal, including zirconia & non-metal), Filling (metal & non-metal), Root canal, Bridge and Implants. It is designed to aid dental health professionals to review bitewing and periapical radiographs of permanent teeth in patients 12 years of age or older as a second reader.
Technology
Second Opinion® consists of a client user interface, an API, and cloud-resident computer vision models using neural network algorithms developed with machine learning. It processes digital bitewing and periapical radiographs, detecting various dental features by generating metadata with pixel regions and graphical overlays for clinician review. It operates as a second reader, providing near-instantaneous detection results.
Performance
Performance testing included standalone and multi-reader multi-case (MRMC) clinical studies showing statistically significant improvement in detection accuracy of dental pathologies when using Second Opinion® as a second reader. Sensitivity improvement ranged from 0.9% to 11.7% across pathologies, with low false positive rates. Verification and validation testing demonstrated compliance with design specifications and special controls for safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
2/8/2021
1 year - 2
FDA Approval
3/4/2022
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