(476 days)
8-global® Blastocyst Fast Freeze Kit - Based on S3:
- Media Intended for cryopreservation of human blastocysts. .
12-global® Blastocyst Fast Freeze Thawing Kit - Based on S3 - Media intended for the thawing and recovery of human blastocysts that . have been cryopreserved using the &-global® Blastocyst Fast Freeze Kit - Based on $3.
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The provided document is a 510(k) summary for the global® Blastocyst Fast Freeze Kit and global® Blastocyst Fast Freeze Thawing Kit. This type of document primarily focuses on demonstrating substantial equivalence to a predicate device and does not typically include detailed studies with acceptance criteria, sample sizes, expert ground truth establishment, or multi-reader multi-case studies as would be found in a clinical trial report or an academic publication on a diagnostic AI device.
Therefore, most of the information requested in your prompt is not present in this 510(k) submission.
Here's what can be inferred or stated based on the provided text, and where information is explicitly missing:
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A table of acceptance criteria and the reported device performance:
- Not present. The document does not provide a table of acceptance criteria or performance metrics. The 510(k) process is about demonstrating substantial equivalence, not necessarily meeting pre-defined performance acceptance criteria with detailed statistical analysis.
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Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not present. There is no mention of a "test set" or any specific study data that would detail sample sizes, data provenance, or study design (retrospective/prospective).
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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 present. As there's no mention of a test set or a study involving establishing ground truth, this information is not available.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not present. No information on an adjudication method is available.
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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 present. The device described is a cryopreservation and thawing media kit for blastocysts, not an AI-powered diagnostic device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this product.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not present. This device is not an algorithm or AI.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not present. No specific ground truth methodology is mentioned as it's not relevant to this type of device submission. Performance claim, if any, would typically be related to viability post-thaw or pregnancy rates, which would be direct outcomes, but no such study is detailed here.
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The sample size for the training set:
- Not present. The device is not an AI/ML algorithm that requires a "training set."
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How the ground truth for the training set was established:
- Not present. Not applicable for this device.
In summary: The provided document is an FDA 510(k) clearance letter and an "Indications for Use" statement for a reproductive media kit. It does not contain the detailed study information, acceptance criteria, or performance data typically associated with the evaluation of AI or diagnostic devices, which your questions are geared towards. The focus of this document is regulatory clearance based on substantial equivalence to predicate devices, not on proving device performance through specific clinical studies with defined endpoints and ground truth.
§ 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.