TRIOS Dx (R1)

TRIOS Dx is a software-only diagnostic aid device that analyzes intraoral scan data using AI/machine learning algorithms to assist dental professionals in diagnosing oral health conditions. It displays diagnostic aid results with graphical overlays on scans and enables assessment of caries, tooth wear, gingival recession, and plaque. The device is intended for use in dental clinics by qualified dental professionals and does not replace clinical decision-making.

Both subject and predicate devices process digital intraoral scans using embedded machine learning and locked neural network algorithms. Key differences include: subject device operates only on Windows vs. predicate's broader platform support; subject device has narrower input specifications; predicate device includes accessories for remote treatment tracking not claimed by subject device. Both display results with graphical overlays and assess changes in teeth and gingiva through similar workflows.

Not stated in this summary. The document references ISO 13485 clauses for design controls, nonconforming product handling, corrective action, and preventative action as required under the Quality Management System Regulation, but does not specify consensus standards used for device testing.

TRIOS Dx is substantially equivalent because all indications for use fall within the predicate device's intended use; both are software diagnostic aids using AI/ML for oral health condition diagnosis; clinical testing demonstrated adequate sensitivity and specificity for plaque, gingival recession, tooth wear, and surface caries without adverse events; the additional indication (caries) does not alter intended therapeutic use or raise different safety/effectiveness questions; and the subject device performs as intended under anticipated use conditions, confirming substantial equivalence.