(57 days)
Giftlife Single-Step Medium Plus is used for culture of embryos from fertilization to the blastocyst stage.
Not Found
The provided FDA 510(k) clearance letter for the "Giftlife® Single-Step Medium Plus" does not contain information regarding acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of an AI/ML device.
This document is a clearance letter for a medical device (Reproductive media and supplements, specifically for embryo culture), not an AI/ML software as a medical device (SaMD). Therefore, the typical acceptance criteria and study data associated with AI/ML performance metrics (such as sensitivity, specificity, AUC, human reader improvement, etc.) are not present in this type of regulatory submission.
The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has been determined to be as safe and effective as a previously cleared device. This determination is based on various factors, including design, materials, chemical composition, intended use, and performance characteristics, but these are assessed through methods appropriate to the device type (e.g., chemical analysis, biological assays, sterility testing, stability studies for culture media), rather than AI/ML performance studies.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number or qualifications of experts for ground truth.
- Adjudication method for a test set.
- MRMC comparative effectiveness study results.
- Standalone AI performance.
- Type of ground truth (expert consensus, pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
These elements are specific to the evaluation of AI/ML devices and are not relevant to the clearance of a reproductive culture medium as described in this document.
§ 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.