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

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I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any studies conducted on the "Enhance-S Plus" device.

The document is a 510(k) premarket notification letter from the FDA, indicating that the device "Enhance-S Plus" has been determined to be substantially equivalent to legally marketed predicate devices. It discusses regulatory classifications, general controls, and responsibilities of the manufacturer. The "Indications for Use Statement" on the last page merely specifies the intended use of the device: "Cell isolation media used for separation and purification of human sperm for assisted reproduction procedures."

Therefore, I cannot provide the requested information.

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

Not Found

This document is an FDA 510(k) clearance letter for a medical device called "Enhance-S Plus," which is described as a "Cell isolation media used for separation and purification of human sperm for assisted reproduction procedures."

The document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any of the detailed information requested in your prompt about how the device meets acceptance criteria.

The letter explicitly states that the FDA "reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This means the clearance is based on substantial equivalence to a pre-existing device, not on new performance studies demonstrating adherence to specific acceptance criteria.

Therefore, I cannot provide the requested table or detail any of the study-related information based on the provided text.

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