(79 days)
Hytac® Aplitip® is a compomer filling material indicated for the following uses: (1) fillings in deciduous teeth; (2) fillings in Class V cavities; (3) eroded and abraded cervical areas; (4) fillings in Class III cavities; and (5) temporary fillings in Class I and II cavities. Hytac® OSB is a light cured bonding agent for use with compomer filling materials.
Hytac® Aplitip® is a compomer filling material. Hytac® OSB is a light cured bonding agent.
This appears to be a 510(k) summary for a dental filling material and bone agent, not an AI/ML medical device. Therefore, the requested information about acceptance criteria, study details, ground truth, and expert involvement is not applicable in the context of AI/ML performance evaluation.
The document discusses substantial equivalence to predicate devices based on physical and technical characteristics, ingredient composition, and biological safety tests (cytotoxicity, Ames, skin irritation, eye irritation, acute oral toxicity, and sensitization). It also states that the products meet relevant DIN and ISO standards for dental composite material. However, these are not the "acceptance criteria" and "study" as one would describe for an AI/ML device's performance metrics (e.g., sensitivity, specificity, AUC).
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.