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Primary tooth fillings Class I, III, and V fillings Wedge-shaped defects Class II semipermanent fillings

HYTAC® is classified as a tooth shade resin material (21 C.F.R. § 872.3690) because it is a device composed of methacrylates intended to restore carious lesions or structural defects in teeth.

The provided text is a 510(k) summary for a dental filling material called HYTAC®. It describes the device, the context for its re-submission to the FDA, and its indications for use. However, it does not include information on acceptance criteria, a study proving the device meets those criteria, or any details related to AI or algorithm performance. The document focuses on the regulatory aspects of changing the indications for use of an already cleared dental product.

Therefore, I cannot fulfill your request for information related to AI acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth as these concepts are not present in the provided text.

The text indicates:

• Device Name: HYTAC®
• Classification Name: Tooth shade resin material
• Common Name: Compomer filling material
• Intended Use: To restore carious lesions or structural defects in teeth.
• Expanded Indications: Class I, III, and V fillings, wedge-shaped defects, and Class II semipermanent fillings (up to two years). Previously limited to non-occlusal loaded fillings.

The change in indications for use was based on "good clinical experience, laboratory test data and comparison to DYRACT® AP by a study," but the specifics of that study (like acceptance criteria, sample size, etc.) are not detailed in this summary.

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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).

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