(116 days)
HTF with HEPES is used as a holding media for human gametes and embryos for assisted reproduction. global with HEPES is used as a holding and transfer medium for human gametes and embryos for assisted reproduction. PGD Biopsy Media is used as a holding medium for human gametes and embryos for assisted reproduction during the cell biopsy procedure used for pre-implantation genetic diagnosis.
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I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving device performance.
The document is a 510(k) clearance letter from the FDA for reproductive media. It confirms that the devices (HTF with HEPES, Global with HEPES, and PGD Biopsy Media) are substantially equivalent to legally marketed predicate devices.
While it states that the FDA reviewed a "premarket notification of intent to market the device," it does not include the details of any specific study, acceptance criteria, or performance data. Such information would typically be found within the 510(k) submission itself, not in the clearance letter.
Therefore, I cannot populate the table or provide answers to the questions regarding sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.
§ 884.6180 Reproductive media and supplements.
(a)
Identification. Reproductive media and supplement are products that are used for assisted reproduction procedures. Media include liquid and powder versions of various substances that come in direct physical contact with human gametes or embryos (including water, acid solutions used to treat gametes or embryos, rinsing solutions, sperm separation media, supplements, or oil used to cover the media) for the purposes of preparation, maintenance, transfer or storage. Supplements are specific reagents added to media to enhance specific properties of the media (e.g., proteins, sera, antibiotics, etc.).(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing). The device, when it is phosphate-buffered saline used for washing, and short-term handling and manipulation of gametes and embryos; culture oil used as an overlay for culture media containing gametes and embryos; and water for assisted reproduction applications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.