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Turbo Temp 3 is a syringe able acrylic provisional composite used for temporary crown and bridge placement.

Turbo Temp 3 is a syringe able acrylic provisional composite used for temporary crown and bridge placement.

I am sorry, but the provided text from the FDA letter regarding K102753 does not contain information about acceptance criteria, device performance results, study details (sample sizes, ground truth establishment, expert qualifications, adjudication methods), or any information about AI or MRMC studies.

The document is a 510(k) clearance letter for a temporary crown and bridge material called "Turbo Temp 3," indicating it has been found substantially equivalent to a legally marketed predicate device. It specifies the product name, regulation number, regulation name, regulatory class, and product code, along with general regulatory information and contact details.

Therefore, I cannot provide the requested table and study details based on the given input.

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THE WEDICAL SOLUTIONS, INC TEMP 3 WARMING CABINET IS DESIGNED TO STORE, REPIDLY HARM AND MAINTAIN TERRERATURE OF I.V. FLUID BAGS AND IRRIGATION BAGS PRIOR TO TICK TO THE IDE.

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The provided documents are a letter from the FDA regarding a 510(k) premarket notification for a medical device called "TEMP 3" and the "Indications For Use" statement.

This document does not contain information about acceptance criteria, device performance, sample sizes for testing or training, data provenance, expert qualifications, ground truth establishment, or any studies conducted. It is a regulatory notification confirming substantial equivalence to a predicate device for marketing purposes.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details based on the provided text.

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