(298 days)
Indications for Use: Media for freezing of blastocyst stage embryos
MOPS buffered media. For use in sequence after the addition of G-MM™ or HSA-solution™ and pre-equilibration at +20 ± 5°C and ambient atmosphere.
The provided text describes a premarket notification for the G-FreezeKit Blast™ device, an Assisted Reproduction Media. However, it does not contain the specific acceptance criteria or a study that proves the device meets such criteria in terms of performance metrics like sensitivity, specificity, accuracy, or effect size.
The document primarily focuses on:
- Device Identification: Trade name, common name, classification, predicate device.
- Description and Intended Use: MOPS buffered media for freezing blastocyst stage embryos.
- Technological Characteristics: Comparison to a predicate device, noting similar cryopreservation ingredients (Glycerol and Sucrose) and a difference in antibiotic (Penicillin G vs. Gentamicin).
- Regulatory Information: FDA 510(k) clearance, substantial equivalence determination, and general controls.
Therefore, I cannot populate the requested table or answer most of the specific questions regarding acceptance criteria, study details, sample sizes, expert involvement, or comparative effectiveness.
The document states that the device is "substantially equivalent" to a legally marketed predicate device (Blastocyst Freeze Media Kit, K000309). This typically means that the device has the same intended use and the same technological characteristics as the predicate device, or if it has different technological characteristics, the information submitted demonstrates that the device is as safe and effective as the legally marketed device and does not raise different questions of safety and effectiveness. The basis for substantial equivalence is often a comparison of technical specifications, safety data, and potentially performance data, but the specific details of such a study are not included in this summary.
Based on the provided text, the following information can be extracted or inferred:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in terms of performance metrics (e.g., survival rates, developmental rates). The implicit acceptance criterion is "substantial equivalence" to the predicate device.
- Reported Device Performance: Not reported in terms of specific performance metrics within this document. The document only states its technological characteristics are "similar" to the predicate, and it contains cryopreservation ingredients and an antibiotic.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not specified in the provided text.
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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 specified in the provided text. This type of detail is generally not included in a 510(k) summary for a media device.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified in the provided text.
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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 device is an Assisted Reproduction Media, not an AI-assisted diagnostic or imaging device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a media product, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for a device like this would typically involve laboratory studies demonstrating embryo viability, survival, and developmental potential after cryopreservation and thawing using the media, compared to the predicate device. However, the specific type and details of such data are not provided in this summary.
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The sample size for the training set:
- Not applicable/Not specified. For a media product, there isn't typically a "training set" in the machine learning sense. Performance data would be generated through laboratory experiments.
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How the ground truth for the training set was established:
- Not applicable/Not specified for the reasons above.
§ 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.