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The Cenorin 610 and Cenorin 610HT Washer-Pasteurizer/High Level Disinfectors are intended for cleaning and high level disinfection of semi-critical and non-critical medical devices using thermal disinfection by full immersion pasteurization.

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The provided document is a 510(k) clearance letter from the FDA for a medical device called "Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT Washer-Pasteurizers/High Level Disinfector."

**This document does not contain any information about acceptance criteria, device performance metrics, sample sizes, expert ground truth establishment, or any details related to a study proving the device meets acceptance criteria. It is a regulatory clearance document, indicating the device has been found substantially equivalent to legally marketed predicate devices.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study proving device performance from the provided text. The document is about a washer-pasteurizer, not an AI/ML powered device, and thus the acceptance criteria would be very different (e.g., sterilization effectiveness, temperature control accuracy, cycle times, etc.) which are not detailed here.

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