(391 days)
"Medi-Cult Blastocyst Freezing Pack" is for freezing of blastocysts in a two step procedure and the "Medi-Cult Blastocyst Thawing Pack" is for thawing of blastocysts in a two step procedure.
"Medi-Cult Blastocyst Freezing Pack" Cat.No. 1012 "Medi-Cult Blastocyst Thawing Pack" Cat.No. 1015. "Medi-Cult M3 Medium" has been used as the basal medium for both products. Furthermore Blastocyst Freezing Pack contains glycerol (vial 1) and glycerol and Sucrose (vial 2). Blastocyst Thawing pack contains sucrose (vial 1 and 2).
The provided text is a 510(k) summary for the "Medi-Cult Blastocyst Freezing Pack" and "Medi-Cult Blastocyst Thawing Pack". This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a detailed clinical study as would be typical for a new drug or a novel, high-risk device.
Therefore, the requested information regarding acceptance criteria, specific device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types is not explicitly present or applicable in the way it would be for AI/ML device submissions.
However, I can extract what is available and explain the context:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) for an in vitro fertilization (IVF) media kit (cryopreservation and thawing solutions), the "acceptance criteria" are related to product quality control and the overall clinical outcome, which is implicitly compared to the predicate device. Specific numerical performance metrics for the device itself (like sensitivity/specificity for a diagnostic AI) are not defined in the provided document.
| Acceptance Criterion (Product Quality Control) | Reported Device Performance |
|---|---|
| Bioburden | Production-test (passes) |
| Integrity filter testing | Production-test (passes) |
| Sterility | QC-test (passes) |
| pH | QC-test (passes) |
| Mouse Embryo Assay (Two cell assay) | > 80% hatched (QC Test passes) |
| Endotoxin | QC-test (passes) |
| Clinical Performance (Implicit) | "the first clinical data available indicates that this product has the same performance as indicated by Menezo et al." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Clinical Performance: Not explicitly stated as a defined "test set" in the context of an AI study. The document refers to "the first clinical data available" but does not specify the number of cases or patients included in this initial data or its origin.
- Data Provenance: The document refers to "the work of Yves Menezo and co workers who have developed a protocol for freezing and thawing of human blastocysts." The "first clinical data available" for the Medi-Cult product indicates performance similar to what Menezo et al. reported. The Menezo et al. work was presented at conferences in the USA (Boston, 1996) and Canada (Vancouver, 1997). Whether the "first clinical data" for the Medi-Cult product itself originated from these regions or elsewhere is not specified. It is implied to be prospective clinical use data given the wording "many clinics have started to use The Medi-Cult Blastocyst Freezing and Thawing pack."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable or available in the provided 510(k) summary. "Ground truth" in the context of fertility treatment is typically live birth rates, successful implantation, or embryo viability, which would be clinical outcomes, not expert consensus on an image or diagnostic finding. The document does not describe a process of expert review for establishing "ground truth" for the device's performance.
4. Adjudication Method for the Test Set
This is not applicable or available. No adjudication process for a "test set" is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This is not applicable or available. The device is an IVF media kit, not an AI diagnostic tool that would typically undergo an MRMC study. There is no mention of human readers or AI assistance.
6. Standalone Performance Study
The "Mouse Embryo Assay (Two cell assay; > 80% hatched)" could be considered a form of standalone performance test for the quality and functionality of the media, demonstrating its ability to support embryo development. However, it's a QC test, not a clinical trial.
The statement "the first clinical data available indicates that this product has the same performance as indicated by Menezo et al." suggests an observation of clinical outcomes with the product, implicitly as a standalone product in clinical practice, but without the rigorous design of a formal standalone clinical trial presented in this summary.
7. Type of Ground Truth Used
For the product quality control tests, the ground truth is against established biological and chemical standards (e.g., sterility, pH ranges, embryo hatching rates).
For the implied clinical performance, the ground truth would be clinical outcomes (e.g., successful blastocyst development post-thaw, pregnancy rates, live birth rates), based on comparison to previously published results by Menezo et al. which established the efficacy of the protocol.
8. Sample Size for the Training Set
This is not applicable or available. As this is not an AI/ML device, there is no "training set" in that context. The "training" for the device's development would involve laboratory research and development of the media formulation.
9. How the Ground Truth for the Training Set Was Established
This is not applicable or available. There is no "training set" to establish ground truth for as it's not an AI/ML device. The formulation is "based on the work of Yves Menezo and co workers who have developed a protocol for freezing and thawing of human blastocysts." The ground truth for their work would have been clinical outcomes and biological viability in their research.
§ 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.