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PVP is used for the intracytoplasmic sperm injection (ICSI) procedure to decrease the motility of spermatozoa, prevent their sticking to the injection pipette during the procedure and to give more control over the flow of fluid in the ICSI needle.

PVP, 10%, (W/V) in Hepes-HTF (Tissue Culture Media)

This document is a 510(k) clearance letter for "PVP, 10%, (W/V) in Hepes-HTF (Tissue Culture Media)" for use in ICSI procedures. It's a regulatory approval document and does not contain information about acceptance criteria or specific study details often found in scientific publications or clinical trial reports.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details from the provided text.

The closest information available is the "Indications For Use," which describes what the device is intended for: to decrease sperm motility, prevent sticking to the injection pipette, and provide more control over fluid flow during ICSI. This is a functional description, not a set of performance metrics or acceptance criteria as you've defined them.

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