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510(k) Data Aggregation
(123 days)
This product is intended for the in vitro culture of human embryos following fertilization until Day 5/6 of development.
VitaVitro® 1-Step Culture Media product intended for the in vitro culture of embryos from fertilization until day 5/6 of development. It is an aseptically filtered, bicarbonate-buffered media containing physiological salt solutions, gentamicin, and human serum albumin. It is ready to use after warming to 37°C and equilibration in a CO2 environment.
The provided text describes the acceptance criteria and the studies performed for the VitaVitro® 1-Step Culture Medium. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Aspect | Acceptance Criteria (Specification) | Reported Device Performance (Summary of results from non-clinical testing) |
|---|---|---|
| Sterility (per USP <71>) | No microbial growth | Met (Implied by conclusion of substantial equivalence based on testing) |
| Osmolality | 250 – 290 mOsm/kg | Met (Implied by conclusion of substantial equivalence based on testing) |
| pH | 7.2 — 7.6 | Met (Implied by conclusion of substantial equivalence based on testing) |
| Endotoxin (per USP <85>) | <0.25 EU/ml | Met (Implied by conclusion of substantial equivalence based on testing) |
| 1-cell MEA | ≥80% developed to the blastocyst stage within 96 hours | Met (Implied by conclusion of substantial equivalence based on testing) |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not explicitly state a specific numerical sample size for the 1-cell Mouse Embryo Assay (MEA) test set. It mentions "One-cell mouse embryos" were exposed, implying a cohort of embryos was used. Without further detail, a precise number cannot be provided.
- Data Provenance: The study was conducted by Shenzhen VitaVitro Biotech Co., Ltd. in China. The data would therefore be prospective for this specific device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not mention the use of human experts to establish ground truth for the 1-cell MEA test. The assessment of blastocyst development appears to be an objective, quantifiable biological outcome rather than a subjective interpretation requiring expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. As noted above, the assessment for the 1-cell MEA is an objective biological outcome, not a subjective interpretation requiring adjudication.
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 medical device for in vitro culture media, not an AI-powered diagnostic or imaging device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical device for in vitro culture media. Its performance is assessed through biological outcomes (embryo development), not through an algorithm's output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the 1-cell MEA, the ground truth is an objective biological outcome: the percentage of embryos that developed to the expanded blastocyst stage within 96 hours. This is a direct measurement of embryo viability and developmental capacity in the presence of the culture medium.
8. The sample size for the training set:
- Not applicable. This device is not an AI/machine learning model, and therefore does not have a "training set" in the conventional sense. The studies described are performance verification tests.
9. How the ground truth for the training set was established:
- Not applicable. As noted above, there is no "training set" for this type of medical device.
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