(312 days)
Medi-Cult PVP products are used for decreasing the motility and movements of sperm before ICSI.
Medi-Cult PVP Medium and Medi-Cult PVP, Clinical Grade
This K991329 submission for "Medi-Cult PVP Medium" appears to be for a medical device (a medium for in-vitro fertilization), not a diagnostic AI system. Therefore, most of the requested information about acceptance criteria for an AI device and a study proving device performance in the context of AI (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) is not applicable to this submission.
The provided text describes a 510(k) summary for a fluid medium used in IVF procedures. The "acceptance criteria" and "study" mentioned in the input are framed around the regulatory approval process for this type of medical device, primarily focusing on safety and effectiveness for its intended use, rather than analytical performance metrics typical of AI medical devices.
Here's how to interpret the available information in the context of the provided document:
1. A table of acceptance criteria and the reported device performance
Since this is a non-AI medical device, the "acceptance criteria" are not performance metrics like sensitivity/specificity but rather regulatory satisfaction based on historical usage and absence of serious adverse events.
| Acceptance Criteria (Implied Regulatory) | Reported Device Performance |
|---|---|
| Satisfaction of users | "The media "Medi-Cult PVP Medium" for support of In-Vitro fertilisation has been used extensively over a number of years to the satisfaction of the users at the IVF- and ART- clinics and laboratories." |
| Absence of serious adverse events | "there is no evidence in the last 1.5 year that the product has been the cause of any serious adverse events in connection with its intended use." |
| Performance in trials/publications | "A number of trials have shown that the Medi-Cult PVP Medium and other products performs well. (see Clinical Testing section reference list). A number of publications in peer- reviewed books or journals have presented data using Medi-Cult media." |
| Substantial Equivalence to predicate | The FDA's letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent... to legally marketed predicate devices..." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable for an AI device. For this IVF medium, the "data" consists of historical usage and outcomes. The submission refers to "extensive use over a number of years" and "a number of trials" and "publications." Specific sample sizes, details of test sets, or data provenance (country, retrospective/prospective) are not provided in this 510(k) summary, as they are not the primary focus for this type of device. The assessment is based on a broad history of safe and effective use.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable for an AI device. This information is not relevant to the approval of an IVF medium. "Ground truth" in this context would implicitly be the observed clinical outcomes of IVF procedures using the medium, as reported by IVF/ART clinics and in published trials.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable for an AI device. This concept does not apply to the regulatory submission for an IVF medium.
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
- Not applicable. This is a non-AI medical device. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a non-AI medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For this device, the "ground truth" or evidence of performance is primarily based on:
- User satisfaction: Implied by "satisfaction of the users at the IVF- and ART- clinics and laboratories."
- Absence of serious adverse events: Explicitly stated as "no evidence...that the product has been the cause of any serious adverse events."
- Outcomes data in clinical trials and publications: "A number of trials have shown that the Medi-Cult PVP Medium and other products performs well." and "A number of publications...have presented data using Medi-Cult media." This would likely encompass various metrics of IVF success and safety.
8. The sample size for the training set
- Not applicable for an AI device. There is no "training set" in the context of an IVF medium.
9. How the ground truth for the training set was established
- Not applicable for an AI device. There is no "training set" or a separate establishment of "ground truth" for it in this context.
§ 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.