Second Opinion® Pediatric
Pearl, Inc.Second Opinion® Pediatric is an AI-driven software designed to assist dental clinicians in detecting caries in bitewing and periapical radiographs of patients aged 4 years and older. It uses machine learning to identify and visually overlay potential caries lesions on dental X-rays, helping clinicians with improved detection accuracy without replacing professional judgment.
Intended Use
Second Opinion® Pediatric is a computer aided detection (CADe) software to aid in the detection of caries in bitewing and periapical radiographs. The intended patient population is patients aged 4 years and older with primary or permanent teeth indicated for dental radiographs.
Technology
The software includes an Application Programming Interface (API), Machine Learning Modules, and Client User Interface. It processes dental radiographic images using neural network-based computer vision algorithms to detect caries lesions and displays these as polygonal overlays atop radiographs within a user interface.
Performance
Performance was evaluated in a standalone retrospective clinical study with 1182 radiographic images containing 1085 caries lesions. The device showed lesion-level sensitivity of 87% (95% CI: 84%-90%) and a false positive per image rate of 1.22. Statistical analysis showed sensitivity significantly greater than 70%, supporting the device's effectiveness comparable to the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/18/2024
4 months - 2
FDA Approval
5/5/2025
Other devices from Pearl, Inc.
- Second Opinion® CS2025 • 510K
- Second Opinion® 3D2025 • 510K
- Second Opinion® BLE2025 • 510K
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