(150 days)
global®: fertilization, embryo culture and transfer medium is intended for the use during fertilization, culture of human embryos and transfer.
global®: fertilization, embryo culture and transfer medium
The provided text is a 510(k) premarket notification letter from the FDA for a medical device called "global®: fertilization, embryo culture and transfer medium." It does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria.
This document is a regulatory approval letter stating that the device is substantially equivalent to legally marketed predicate devices. It does not elaborate on the specific performance studies, acceptance criteria, or statistical details typically found in a clinical study report or a more comprehensive section of a 510(k) submission.
Therefore, I cannot extract the requested information from the provided text.
To answer your request, I would need a document that includes sections like:
- Performance Data / Clinical Data: Details on studies conducted.
- Acceptance Criteria: Specific thresholds for device performance.
- Study Design: Information on sample size, data provenance, ground truth establishment, etc.
- Results: Reported device performance metrics.
In summary, none of the requested information (acceptance criteria table, sample size for test set, data provenance, number of experts, adjudication method, MRMC study details, standalone performance, ground truth type, training set sample size, training set ground truth method) is present in the provided FDA letter.
§ 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.