(193 days)
The LAG medium is for pre-incubation of immature oocytes and the IVM Medium is a basal medium for maturing immature oocytes of infertile women undergoing in vitro fertilization who for medical reasons can not undergo conventional ovarian stimulation using drugs.
MediCult IVM® System including Vial 1, LAG Medium and Vial 2 , IVM®Medium. The MediCult IVM® System is a sequential media system including LAG Medium and IVM®Medium which has been developed specifically to support maturation in-vitro of immature oocytes. The composition of the LAG medium is similar to the composition of Universal IVF Medium. Like the Universal IVF Medium the IVM®Medium contains physiological salts and nutritients but differs from this medium by also containing vitamins, amino acids and nucleotides and by being free from human serum albumin.
The provided document describes the MediCult IVM® System, a medical device used for in vitro maturation of immature oocytes. The information focuses on establishing substantial equivalence to a predicate device rather than a standalone study proving specific performance metrics against pre-defined acceptance criteria for a diagnostic AI device.
Therefore, many of the requested categories are not applicable to this type of regulatory submission. However, I will extract the available information.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Not explicitly stated as numerical targets) | Reported Device Performance |
|---|---|---|
| Product Testing Controls | Sterility | Certificate of Analysis available per batch |
| pH | Certificate of Analysis available per batch | |
| Osmolality | Certificate of Analysis available per batch | |
| Endotoxin | ≤ 0.1 EU/ml (USP, Ph.Eur.) (Reported as a limit met for each batch) | |
| Mouse Embryo Assay | Blastocyst rate > 80% (Reported as a limit met for each batch) | |
| Clinical Performance (Equivalence to Predicate) | Pregnancy rates per embryo transfer using IVM System (immature oocytes) compared to Universal IVF Medium (mature oocytes) | "slightly lower than the results obtained using mature oocytes and the Universal IVF Medium." |
| Safety | No registered complaints, no evidence of serious adverse events associated with intended use. | "During our studies there have been no registered complaints and no evidence that the product has been the cause of any serious adverse events in connection with its intended use." |
| Effectiveness (Equivalence to Predicate) | Effective for preparing immature oocytes for insemination, substantially equivalent to Universal IVF Medium (K991279) for preparing mature oocytes. | Concluded that both are effective, and IVM® System is substantially equivalent. |
| Shelf Life | 8 weeks from shipment date | "shelf life of 8 weeks from shipment date is recommended." |
| Biocompatibility | Not in contact with patient, so not applicable. | "As the MediCult IVM®System is not in contact with the patient, biocompatibility studies have not been performed." |
2. Sample Size Used for the Test Set and Data Provenance
The document refers to two "studies" but these appear to be clinical observations or comparisons rather than formal, controlled trials with a defined "test set" sample size for evaluating a diagnostic AI device.
- Sample Size: Not explicitly stated as a number of cases or patients for a test set. The document refers to "the pregnancy rates obtained after retrieval of immature oocytes" and compares them to "the pregnancy rates obtained after retrieval of mature oocytes." This suggests aggregate data from patient cohorts.
- Data Provenance:
- Country of Origin: Denmark (Herlev University Hospital) and Finland (Väestöliitio, the Infertility Clinic of the Family Federation of Finland in Helsinki).
- Retrospective or Prospective: Not explicitly stated, but the description of comparing "pregnancy rates obtained" suggests data collected over time rather than a single prospective, controlled study designed for regulatory submission with a fixed test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
N/A. This information is typically relevant for diagnostic AI devices where human experts establish ground truth for image or data interpretation. For a media system, the "ground truth" would be the biological outcomes (e.g., successful maturation, fertilization, pregnancy rates), which are reported directly from clinical data, not "established" by experts in the same way.
4. Adjudication Method for the Test Set
N/A. Adjudication methods (like 2+1 or 3+1) are used to resolve disagreements among experts when establishing ground truth for diagnostic AI. This is not applicable here.
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 device is not an AI-powered diagnostic tool, so an MRMC study comparing human reader performance with and without AI assistance is not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This is a cell culture medium, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" in this context refers to clinical outcomes data, specifically:
- Successful maturation of oocytes (implied by subsequent processes)
- Pregnancy rates per embryo transfer
- Absence of serious adverse events
8. The Sample Size for the Training Set
N/A. There is no concept of a "training set" as this is not an AI/machine learning device. The studies mentioned essentially served as general clinical experience or observational data rather than a structured training phase for an algorithm.
9. How the Ground Truth for the Training Set was Established
N/A. Not applicable for this type of 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.