(56 days)
Medium for culture of embryos from the pronucleate stage to day 2 or day 3.
Bicarbonate buffered medium containing Hyaluronan. For use after the addition of G-MMTM or HSA-solution™ and pre-equilibration at +37°C and 6% CO2.
The provided text is a 510(k) premarket notification summary and a letter from the FDA regarding the G-1TM version 3 Assisted Reproduction Media. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way a medical device utilizing AI/machine learning would.
This device is a culture medium, not an AI-powered diagnostic tool. Therefore, the requested information about sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set size, and ground truth establishment for training sets, is not applicable and cannot be extracted from this document.
The document focuses on demonstrating substantial equivalence to a predicate device (G1.2TM) based on technological characteristics and intended use. The "improvement in performance" mentioned refers to the chemical formulation of the culture medium itself, not the performance of an algorithm or diagnostic accuracy.
§ 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.