Second Opinion® 3D
Pearl, Inc.Second Opinion® 3D is an AI-powered software that helps dental professionals by automatically identifying and marking important anatomical structures in dental CBCT (Cone Beam Computed Tomography) radiographs. It highlights areas such as dentition, maxilla, mandible, and other key dental anatomical features, supporting clinicians to review images more efficiently and accurately. The software acts as a concurrent and second reader for patients aged 12 years or older, assisting in dental evaluation without replacing full clinical patient assessment.
Intended Use
Second Opinion® 3D is a radiological automated image processing software device intended to identify and mark clinically relevant anatomy in dental CBCT radiographs; specifically Dentition, Maxilla, Mandible, Inferior Alveolar Canal and Mental Foramen, Maxillary Sinus, Nasal space, and airway. It should not be used in lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis. It is designed to aid health professionals reviewing CBCT radiographs of patients 12 years of age or older as a concurrent and second reader.
Technology
Second Opinion® 3D consists of an Application Programing Interface (API), Machine Learning Modules (ML Modules), and a Client User Interface. It uses machine learning algorithms (neural networks) to automatically identify and segment anatomical structures on dental CBCT radiographs, producing mask overlays that highlight relevant anatomy on images for clinician review.
Performance
Bench testing was performed on 100 CBCT images encompassing dentition, maxilla, mandible, IAN space, sinus, nasal space, and airway. The device demonstrated statistically significant accuracy in segmenting these anatomies with Dice similarity coefficient scores ranging from 0.76 to 0.97, all with p-values < 0.000001. The bench testing supports the device's safety and effectiveness for its intended use.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/26/2024
4 months - 2
FDA Approval
5/23/2025
Other devices from Pearl, Inc.
- Second Opinion® CS2025 • 510K
- Second Opinion® BLE2025 • 510K
- Second Opinion® Pediatric2025 • 510K
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