Second Opinion® BLE
Pearl Inc.Second Opinion BLE is a software tool that uses AI to help dental professionals measure bone levels in bitewing and periapical radiographs. It assists clinicians by automatically detecting and displaying bone level measurements to aid in patient assessment, but it is not intended to replace full clinical evaluation.
Intended Use
Second Opinion BLE is a radiological automated image processing software device intended to identify and display bone level measurements in bitewing and periapical radiographs to aid dental health professionals in reviewing permanent teeth in patients 12 years or older as a concurrent and second reader. It should not be used in lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis.
Technology
Second Opinion BLE consists of an API, machine learning modules, and a client UI. It uses machine learning to detect bone level measurements on bitewing and periapical radiographs, producing detection outputs as metadata which are visualized as linear overlays on original images.
Performance
Clinical testing used retrospective radiograph data from 396 subjects, involving three licensed dentists and two dental radiologists for adjudication. The device demonstrated precision and recall values around 87-91% for interproximal bone level measurements and met pre-specified acceptance criteria including mean absolute difference less than 1.5 mm in bone level measurements across bitewing and periapical images.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
10/8/2024
7 months - 2
FDA Approval
5/9/2025
Other devices from Pearl Inc.
- Second Opinion® CS2025 • 510K
- Second Opinion® 3D2025 • 510K
- Second Opinion® Pediatric2025 • 510K
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