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The product is intended to be used for the separation and purification of spermatozoa by density gradient centrifugation of human semen samples, where the prepared sperm are used for the treatment of involuntary infertility by utilizing one of the Assisted Reproductive Technologies (ART).

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 does not contain any information about acceptance criteria, detailed study designs, or performance metrics in the way a modern AI/software device submission would. This document is a 510(k) summary for a sperm separation medium (PureSperm®), a laboratory reagent, from 1998.

Here's why the requested information cannot be extracted and what can be inferred:

• Device Type: This is a chemical reagent, not a digital health/AI device. Therefore, the concepts of "algorithm performance," "ground truth," "training set," "test set," "multi-reader multi-case (MRMC) studies," or "human-in-the-loop performance" are not applicable in the context of this submission.
• Regulatory Era: This submission dates back to 1998, long before the current rigorous standards for clinical validation of AI/software as a medical device (SaMD) were established.
• Submission Content: The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device based on identical composition, product testing results, and intended use. It does not elaborate on detailed clinical trials or performance studies as would be expected for a diagnostic or therapeutic device today.

Therefore, I cannot fulfill your request for the specific numbered points (1-9) as they relate to AI/software device validation. The information is simply not present in the provided text.

What can be extracted and inferred from the text regarding its safety and effectiveness:

• Claim of Safety and Effectiveness: "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." (Section 5)
• Basis for Equivalence: "Based on the identical composition, product testing results, and intended use, PureSperm® is substantially equivalent to the predicate device named above." (Section 6)
• Predicate Device: PureSperm® (K980814)

In summary, the document states that the device was deemed "safe and effective" and "substantially equivalent" to a predicate based on "clinical trials and comparative testing," but it does not provide any specifics about these trials, their methodology, acceptance criteria, or quantitative results.

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