(428 days)
"Medi-Cult M3 Medium" is intended for the culture of embryos from day 3 and up to day 7.
"Medi-Cult M3 Medium" is based on MCDB 302; a modification of HAM's F10 and F12 composed of amino acids, vitamins, inorganic salts and glucose supplemented with: Assisted Reproduction Technique Supplement (ARTS) Sodium Bicarbonate Human Serum Albumin (HSA) (obtained from a licensed source, U.S. license No. 140) Penicillin (Except product 1032) Streptomycin (Except product 1032) Phenol Red (Except product 1037)
The provided text describes the 510(k) submission for the "Medi-Cult M3 Medium," a culture medium for human embryos. This document focuses on demonstrating the substantial equivalence of this device to previously marketed predicate devices, rather than presenting a study to prove the device meets specific acceptance criteria in the way an AI/ML device would.
Therefore, many of the requested categories for AI/ML device studies (like expert consensus, standalone performance, MLMC studies, specific sample sizes for training/test sets for an algorithm, etc.) are not applicable to this document as it pertains to a biological culture medium product and not a software algorithm.
However, I can extract information related to the device's performance and the studies mentioned to support its substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Embryo Viability/Development (Blastocyst Formation Rate) (Implied: Not inferior to predicate devices for extended culture) | Study 1 (Sahlgrenska hospital): Similar rate of blastocyst formation compared to Scandinavian Science S2 medium. |
| Study 2 (Jones Institute): Similar rate of blastocyst formation (26% vs 27% respectively) when compared to a system using S1 and S2 from Scandinavian IVF Science. | |
| Safety (Absence of adverse events/complaints) (Implied: No evidence of serious adverse events or registered complaints) | No registered complaints on the product. No evidence in the last 1.5 year that the product caused serious adverse events in connection with its intended use. |
2. Sample size used for the test set and the data provenance
- Study 1 (Sahlgrenska hospital in Gothenburg, Sweden): Specific sample size not provided. Data provenance: Prospective, randomized study from Sweden.
- Study 2 (Jones Institute for Reproductive Medicine, Norfolk, USA): Specific sample size not provided. Data provenance: Prospective, randomized study from the USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable (N/A). This is a biological culture medium, not an AI/ML device. The "ground truth" here is the biological outcome (blastocyst formation), observed and recorded by clinicians/embryologists, not an interpretation by experts for algorithm validation. Dr. Anita Sjogren (Dept of Ob. & Gyn.) is referenced for data from one study, implying clinical oversight.
4. Adjudication method for the test set
- N/A. As above, this is about biological outcomes, not expert interpretation requiring adjudication. Clinical and embryological protocols would be followed for assessing outcomes.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- N/A. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is not an AI/ML device.
7. The type of ground truth used
- Biological Outcomes: The primary "ground truth" or outcome measure for the effectiveness of the culture medium was the rate of blastocyst formation in human embryos. This is a direct biological measure. Safety was assessed by the absence of complaints or serious adverse events.
8. The sample size for the training set
- N/A. This is not an AI/ML device. The term "training set" doesn't apply. The product was used in IVF units in Europe since the late 1980s, providing extensive historical use data, but not a formally defined "training set" for an algorithm.
9. How the ground truth for the training set was established
- N/A. This is not an AI/ML device.
§ 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.