Second Opinion® CS

Second Opinion® CS is computer-aided detection (CADe) software designed to help dental professionals detect and segment caries (cavities) in periapical radiographs of permanent teeth in patients 12 years and older. The software uses machine learning to identify suspected carious lesions and overlay them on the original radiograph, providing a detailed analysis showing the percentage overlap of the lesion with dentin and enamel.

The device uses neural network-based computer vision algorithms developed with supervised machine learning to process digital intraoral radiographs on Windows operating systems. It demarcates detections within a user interface with graphical overlays and produces near-instantaneous detection results. The key distinction from the primary predicate is that Second Opinion CS adds caries lesion anatomical segmentation (enamel and dentin percentages), whereas the original Second Opinion did not include segmentation.

Not stated in this summary.

Second Opinion CS is substantially equivalent because it maintains the same intended use as the predicate devices—aiding dentists in caries detection in periapical radiographs using CADe software with machine learning. The clinical evidence demonstrates comparable or superior performance: the standalone study showed 88% sensitivity in caries detection, and the MRMC study demonstrated statistically significant improvement in aided reader performance (wAFROC-FOM difference: 0.05, p=0.0345) with reliable segmentation accuracy. The addition of segmentation analysis (enamel/dentin percentages) represents an enhancement to the same fundamental technology and intended use, raising no new safety or effectiveness concerns.