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For the support of the oocyte during intracytoplasmic sperm injection.

Medium for In Vitro Fertilization Procedures

MOPS buffered medium. For use after the addition of G-MM™ or HSA-solution™ and temperature equilibration at +37°C and ambient atmosphere.

The provided document is a 510(k) premarket notification summary for G-OOCYTE™, an Assisted Reproduction Media. It includes information about the device's intended use and technological characteristics, as well as the FDA's substantial equivalence determination. However, it does not contain any information regarding specific acceptance criteria, study methodologies, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth establishment for a device performance study.

The document states that the "Technological characteristics of G-OOCYTE are essentially similar to those of the predicate device. Formulation changes were made with the needs of the denuded unfertilized oocyte in mind. None of these changes raise new questions of safety or effectiveness." This suggests that the substantial equivalence was primarily based on the similarity to the predicate device (G-MOPS™ K021893) and the assessment that the formulation changes did not introduce new safety or effectiveness concerns, rather than a new performance study demonstrating specific acceptance criteria.

Therefore, I cannot provide the requested information as it is not present in the provided text.

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