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Sperm Freeze is intended to be used as a cryopreservation medium for human sperm.

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The provided text is a 510(k) clearance letter from the FDA for a device named "Enhance Sperm Freeze" (later referred to as "Sperm Freeze"). This document does not contain any information about the acceptance criteria or a study that proves the device meets specific performance metrics.

Instead, this document focuses on:

• Substantial Equivalence: The FDA's determination that "Enhance Sperm Freeze" is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.
• Regulatory Information: Details about regulatory classification (Class II), applicable regulations, and requirements for marketing the device.
• Indications for Use: Stating that "Sperm Freeze is intended to be used as a cryopreservation medium for human sperm."

Therefore, I cannot provide the requested information from this document regarding acceptance criteria, device performance, study details, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth establishment. These details would typically be found in the 510(k) submission itself or a separate clinical/performance study report, not in the clearance letter.

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