(112 days)
LG Sperm Freezing Medium is intended to be used for the cryopreservation of human sperm.
Not Found
This document is a 510(k) clearance letter from the FDA for a device called "LG Sperm Freezing Medium." It is not a study report that describes acceptance criteria and device performance data.
Therefore, I cannot provide the requested information such as:
- A table of acceptance criteria and reported device performance
- Sample size used for the test set and data provenance
- Number of experts used to establish ground truth and their qualifications
- Adjudication method
- MRMC comparative effectiveness study details
- Standalone performance details
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
This document only states that the FDA found the device substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It does not contain the detailed study information you are looking for.
§ 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.