Second Opinion® CS
Pearl Inc.Second Opinion® CS is a computer-aided detection software designed to help dental health professionals detect and segment caries in radiographs of permanent teeth. Using AI and machine learning, it highlights potential caries lesions and provides detailed analysis on their overlap with tooth structures, improving diagnostic accuracy and assisting clinicians in reviewing dental images.
Intended Use
Second Opinion® CS is a computer aided detection ("CADe") software to aid dentists in the detection and segmentation of caries in periapical radiographs, designed for dental health professionals to review permanent teeth images in patients 12 years or older as a second reader.
Technology
Second Opinion® CS uses machine learning-based computer vision neural network algorithms to detect and segment caries on digital periapical radiographs. It processes images via an API linked to machine learning modules and displays results as overlays highlighting caries with segmentation showing lesion overlap with dentin and enamel.
Performance
The device's safety and effectiveness were demonstrated via standalone retrospective studies and multi-reader multi-case (MRMC) clinical trials showing improved caries detection sensitivity (>70%) and effective lesion segmentation compared to ground truth and predicate devices. Statistically significant improvement was observed with AI aided reading over unaided. The device met its primary endpoints with robust segmentation accuracy and manageable false positive rates.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
10/10/2024
8 months - 2
FDA Approval
6/12/2025
Other devices from Pearl Inc.
- Second Opinion® 3D2025 • 510K
- Second Opinion® BLE2025 • 510K
- Second Opinion® Pediatric2025 • 510K
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