(88 days)
G-MM contains Recombinant Human Albumin solution (50 mg/mL) and is intended for use in assisted reproductive procedures which include gamete and embryo manipulation. These procedures include the use of G-MM as a supplement for culture medium. Not for use as an injectable product.
Recombinant Human Albumin solution. For supplementation of gamete and embryo media.
The provided text is a 510(k) premarket notification summary and an FDA clearance letter for a medical device called "G-MMTM Assisted Reproduction Media." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving the device meets specific acceptance criteria through a clinical study in the way a new, higher-risk device would.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, device performance, study details (sample sizes, data provenance, ground truth, experts, adjudication, MRMC, standalone performance), or training set information.
Here's why and what information is available:
- No Acceptance Criteria or Reported Device Performance Table: The 510(k) process focuses on demonstrating substantial equivalence to a predicate device, not on meeting predefined performance metrics for a novel technology. The "performance" assessment is comparative. The text states: "Analytical, preclinical, and clinical testing performed on the recombinant albumin component of the device confirmed that the G-MM device is at least as safe and effective as the predicate device." This is the general finding, not a report against specific acceptance criteria.
- No Dedicated "Study" for Acceptance Criteria: The provided document states that "analytical, preclinical, and clinical testing" was performed to confirm the new device is "at least as safe and effective as the predicate device." This indicates a comparative approach. Details about these tests (sample sizes, ground truth, experts, etc.) are not included in this summary.
- No Information on Sample Sizes (Test Set or Training Set), Data Provenance, Number of Experts, Adjudication, MRMC, or Standalone Performance: These are all elements typically found in clinical study reports for devices that require extensive performance validation. A 510(k) summary often abridges the detailed study information, focusing on the substantial equivalence argument. For a media like this, "clinical testing" would likely involve in vitro fertilization (IVF) success rates or embryo development outcomes compared to the predicate, but specific details are absent.
- No Information on Ground Truth for Test or Training Sets: Again, this level of detail is not present in the provided 510(k) summary.
In summary, the provided document is a regulatory submission for substantial equivalence, not a detailed clinical study report with acceptance criteria and performance metrics against them.
§ 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.