Second Opinion CC
Pearl Inc.Second Opinion CC is a specialized AI software designed to assist dental professionals in identifying dental caries on bitewing and periapical radiographs. It processes dental X-ray images and highlights potential caries regions using polygonal contours, helping clinicians review images more effectively as a second reader without replacing their clinical judgment.
Intended Use
Second Opinion CC is a computer aided detection (CADe) software to aid dentists in the detection of caries by drawing bounding polygons to highlight the suspected region of interest. It is designed to aid dental health professionals to review bitewing and periapical radiographs of permanent teeth in patients 19 years of age or older as a second reader.
Technology
The device uses machine learning-based computer vision algorithms to analyze digital bitewing and periapical radiographs. It processes images through an API and machine learning modules to produce detections represented as metadata, which are rendered on a user interface as polygonal overlays indicating potential caries.
Performance
Performance testing included a non-inferiority standalone clinical study comparing polygonal detections of Second Opinion CC to bounding box detections by the predicate device. The study on 500 diverse radiographs showed Second Opinion CC is non-inferior with a lesion level sensitivity of 90% and clinically acceptable segmentation accuracy (Dice coefficient 0.73).
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/23/2024
4 months - 2
FDA Approval
1/16/2025
Other devices from Pearl Inc.
- Second Opinion2022 • 510K
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