(88 days)
Medium for culture of embryos from day 3 to the blastocyst stage.
Bicarbonate-buffered medium. For use after the addition of HSA-solutionTM or G-MMTM and equilibration at +37°C and 6% CO2
This is a 510(k) premarket notification for a medical device called G-2™ version 3, an Assisted Reproduction Media. The primary reference describes the device and its intended use, stating it is a "Medium for culture of embryos from day 3 to the blastocyst stage."
The provided document is a 510(k) clearance letter from the FDA, and as such, it does not contain detailed acceptance criteria, device performance results, or information about specific studies like those typically found in clinical trial reports or peer-reviewed publications. The FDA's 510(k) process is primarily focused on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving efficacy or detailed performance against pre-defined acceptance criteria through in-depth clinical studies in the same way a PMA (Premarket Approval) would.
Therefore, for many of your questions, the answer will be that the information is not provided in this specific document.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided | Not provided |
- Explanation: This document is an FDA clearance letter based on substantial equivalence. It does not detail specific performance metrics or acceptance criteria for the new device itself, nor does it present results from a study demonstrating specific performance against such criteria. The "technological characteristics" are stated to be "identical to other legally marketed culture media," implying that its performance is expected to be equivalent to those predicate devices.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
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Sample size for test set: Not provided.
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Data provenance: Not provided.
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Retrospective or prospective: Not provided.
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Explanation: The document does not describe any specific "test set" or a study designed to gather new performance data. The clearance is based on substantial equivalence to a predicate device, which usually involves comparing the device's characteristics to the predicate's, not necessarily conducting a new clinical study.
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)
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Number of experts: Not applicable/Not provided.
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Qualifications of experts: Not applicable/Not provided.
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Explanation: Since no specific test set or clinical study to establish ground truth is described, this information is not relevant to the provided content.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
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Adjudication method: Not applicable/Not provided.
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Explanation: No test set or ground truth establishment process is detailed.
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
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MRMC study: No.
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Effect size: Not applicable.
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Explanation: This device is an assisted reproduction culture medium, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
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Standalone study: No.
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Explanation: This device is a culture medium, not an algorithm, so the concept of a "standalone" algorithmic performance study does not apply.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
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Type of ground truth: Not applicable/Not provided.
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Explanation: The document does not describe the establishment of a "ground truth" through a clinical study for this device, as its clearance is based on substantial equivalence to a predicate device.
8. The sample size for the training set
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Sample size for training set: Not applicable/Not provided.
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Explanation: As this is a culture medium and not an AI/ML device, the concept of a "training set" is not relevant here.
9. How the ground truth for the training set was established
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How ground truth was established: Not applicable/Not provided.
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Explanation: The concept of a training set and its ground truth does not apply to this type of device.
Summary of what the document does indicate regarding "study":
The FDA's clearance is based on the device's "substantial equivalence" to a legally marketed predicate device (G2.2TM). This means that a comparison was made between the new device and the predicate device, likely focusing on their technological characteristics, intended use, and safety profiles. The document states: "The technological characteristics of G-2TM version 3 are identical to other legally marketed culture media classified under 21 C.F.R. § 884.6180, Reproductive Media and Supplements." This statement is the "proof" that the device meets the criteria for substantial equivalence, implying it functions similarly and has similar performance expectations as already cleared devices, rather than being a detailed report of a new clinical study.
§ 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.