Second Opinion® BLE

Second Opinion® BLE is a radiological automated image processing software device that uses machine learning to identify and display bone level measurements in bitewing and periapical dental radiographs. It is designed to aid dental health professionals in reviewing permanent teeth radiographs of patients 12 years and older as a concurrent and second reader, and should not be used as a sole basis for diagnosis.

The device utilizes computer vision neural network algorithms developed from open-source models using supervised machine learning techniques, operates on Windows systems, processes digital intraoral bitewing and periapical radiographs, displays measurements as linear overlays on radiographs with near-instantaneous detection results, and is classified as moderate level software concern. It shares the same technology and approach as the predicate devices for automated bone level measurement detection and display.

Not stated in this summary.

Second Opinion® BLE is substantially equivalent to the predicate device (Overjet Dental Assist, K210187) because both devices share the same intended use of aiding dental professionals in measuring bone levels from bitewing and periapical radiographs using machine learning. Both employ identical technology (neural network-based computer vision), operate on Windows systems, produce graphical overlays on radiographs, and display measurements in near-instantaneous fashion. Clinical testing demonstrated 87-91% precision and recall metrics that met prespecified acceptance criteria (>82%), and mean absolute measurement differences of 0.45-0.86 mm met the acceptance threshold of <1.5 mm, indicating equivalent safety and effectiveness performance to predicate devices.