(180 days)
Sperm Freezing Medium is intended for the cryopreservation of human semen samples to sperm samples during cryopreservation and thawing prior to use in assisted reproductive technology procedures.
Not Found
I am sorry, but based on the provided text, there is no information available about the acceptance criteria or a study proving that a device meets such criteria.
The document is an FDA 510(k) clearance letter for a device named "Sperm Freezing Medium." This letter confirms that the device is substantially equivalent to a legally marketed predicate device. It discusses regulatory requirements, such as general controls, quality systems, and UDI, but it does not include any details about performance criteria or studies conducted by the manufacturer to demonstrate the device's performance.
Therefore, I cannot provide the requested information, including the table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, or training set size.
§ 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.