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• · Etching the enamel and dentin for adhesive restorations ·

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I am sorry, but based on the provided document, I cannot answer the request. The document is a 510(k) premarket notification letter for a dental etching gel (DMP Etching Gel). It states that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory requirements.

However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, details about AI assistance studies, standalone algorithm performance, or how ground truth was established. It focuses solely on the regulatory clearance process for a dental product.

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