(78 days)
The product is intended to be used for decreasing the motility and movements of sperm before ICSI.
SpermCatch™ is a medium designed to modulate sperm motility in a physiological manner, to facilitate injecting a single sperm into an oocyte (ICSI). ICSI is an available procedure in Assisted Reproduction Technology (ART).
SpermCatch is optimised for slowing sperm motility prior to ICSI and is ready-to-use in direct replacement for PVP products. SpermCatch is supplied as a sterile (filtered), isotonic salt solution. Volume 5x100 uL. Product No. SC-100
The provided text is a 510(k) summary for the SpermCatch device, which is an assisted reproduction medium. It states that the device is "as safe and effective as the predicate device" based on "clinical trials and comparative testing." However, the document does not include specific acceptance criteria, detailed study designs, or reported device performance metrics in the format requested.
Therefore, I cannot fully complete the table and answer all questions directly from the provided text. The information below reflects what can be extracted and highlights what is missing.
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. The document claims the device is "as safe and effective as the predicate device." | Not explicitly stated in the document. The document claims the device is "as safe and effective as the predicate device." |
Missing Information: The document does not provide quantifiable acceptance criteria (e.g., minimum percentage reduction in sperm motility, range of viability maintained, etc.) or specific numerical results from the device's performance that directly address such criteria.
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document mentions "clinical trials and comparative testing" but does not provide details on sample size for any test sets.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The document does not describe how ground truth was established for any "clinical trials" or "comparative testing" that might have been conducted.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified.
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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 medium, not an AI-powered diagnostic or interpretive tool that would involve human "readers" or AI assistance in that context.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical device (a liquid medium), not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not specified. Given the device's function (slowing sperm motility), ground truth would likely involve measurements of sperm motility, viability, and potentially fertilization rates, but the exact method for establishing this is not detailed.
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The sample size for the training set:
- Not applicable/Not specified. As a medical device (a liquid medium) rather than a machine learning algorithm, the concept of a "training set" in the AI sense does not apply directly. If "training set" refers to data used to formulate the product, this is not disclosed.
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How the ground truth for the training set was established:
- Not applicable/Not specified. See 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.