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Promotor Final Rinse Sperm Wash is to be used as a sperm processing medium in washing procedures and for transport of sperm during reproductive technology procedures.

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I am sorry, but the provided text is a set of FDA letters regarding a product called "Promotor Final Rinse Sperm Wash Medium" and does not contain the information requested about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment. This document is a regulatory approval letter, not a clinical study report. Therefore, I cannot fulfill your request based on the given input.

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Cell isolation media used for separation and purification of human sperm for assisted reproduction procedures.

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This document is a 510(k) clearance letter from the FDA for a device called "Promotor Regulation Number: 21 CFR 884.6180". It indicates that the device has been found substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot provide the requested information. The document primarily focuses on the regulatory clearance and the administrative details of the approval process.

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