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Sperm Preparation Media is a culture media used to prepare sperm prior to Intrauterine Insemination (IUI) procedures. The preparation of sperm includes washing of the sperm and its separation from the semen.

Sperm Preparation Media is a mineral essential media with glucose and penicillin. This product is provided in sterile bottles. This products as indicated in the label is For In Vitro Use Only.

This document is a Premarket Notification (510(k)) for a medical device. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert evaluations that would typically be found in a clinical study report or a more detailed device performance section.

Therefore, I cannot extract the requested information from the provided text. The document focuses on the equivalence of the "GenX Sperm Preparation Media" to an existing product based on its ingredients and intended use, rather than presenting a detailed performance study with acceptance criteria.

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