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The product is intended to be used for the separation and purification of human sperm by density gradient centrifugation for intrauterine insemination (IUI).

The product PureSperm® is a based on a buffered salt solution which contains a colloidal suspension of silica particles, with hydrophilic silane covalently bound to the particles. The pH, osmolality and salts of PureSperm® are formulated to be compatible with human sperm during their centrifugal separation and purification. The product is packaged in three bottle sizes, 100, 250 and 1000 mL, and these bottles, being Type I borosilicate glass, are packaged individually in white virgin-fibre cartons. Both the bottles and the cartons have pharmaceutically approved labels showing batch number, production date and expiration date. In addition, every carton contains an insert with a full description of the product, including instructions for use and precautions.

The provided text is a 510(k) summary for the PureSperm® Sperm Separation Medium. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not include detailed information regarding specific acceptance criteria, a comprehensive study outline with performance metrics, sample sizes, ground truth establishment, or any details about AI integration.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.

Specifically, the document states:

• "The results of clinical trials and comparative testing against predicate products indicates that the new device is as safe and effective as the predicate devices."
• "Based on the similarity of composition, product testing results, and intended use, PureSperm® is substantially equivalent to the predicate devices named above."

These statements are high-level conclusions and do not provide the detailed scientific study parameters that you have requested in your prompt. There is no table of acceptance criteria, no reported device performance metrics (e.g., sensitivity, specificity, accuracy, or any performance on sperm separation quality), no sample sizes for test or training sets, no information on experts, no adjudication methods, no mention of MRMC studies or AI involvement, and no specifics on how ground truth was established beyond a general mention of "product testing results."

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