(44 days)
The product is intended to be used cryopreservative for protecting human sperm during cryopreservation, an adjunct to one of the techniques for ART (assisted reproductive technology).
Sperm CryoProtec™ is a buffered salt solution containing human serum albumin and glycerol (10%), has a stable shelf-life of at least 12 months in the unopened bottle at ambient temperature. The product has extremely low endotoxin levels, protects sperm during cryopreservation, and is produced according to cGMP (pharmaceutical device registration). No material of animal origin is included in the product and no antibiotics are present, since antibiotics can have a detrimental effect on sperm. Glycerol, which is also toxic to sperm, is present at the lowest concentration found to be compatible with a cryoprotectant effect.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Sperm CryoProtec™ device:
The provided documents are a 510(k) summary and the FDA's clearance letter. These documents describe the device and its intended use, and state that the device is substantially equivalent to a predicate device based on clinical trials and comparative testing. However, they do not provide detailed acceptance criteria or the specific methodologies of the clinical trials or comparative testing. The information is high-level and focuses on regulatory equivalence rather than detailed performance metrics.
Therefore, many of the requested items cannot be definitively answered from the provided text.
Acceptance Criteria and Device Performance
The provided text states: "The results of clinical trials and comparative testing against predicate product indicates that the new device is as safe and effective as the predicate device." This is the core acceptance criterion presented – substantial equivalence in safety and effectiveness to the predicate device.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criterion | Reported Device Performance | Comments from Document |
|---|---|---|
| Safety | As safe as predicate device | "The results of clinical trials and comparative testing against predicate product indicates that the new device is as safe and effective as the predicate device." |
| Effectiveness | As effective as predicate device | "The results of clinical trials and comparative testing against predicate product indicates that the new device is as safe and effective as the predicate device." |
| Intended Use | Same as predicate device | "The intended use of the product is the same." |
| Composition | Similar to predicate device | "Based on the similarity of composition, product testing results, and intended use, Sperm CryoProtec™ is substantially equivalent to the predicate device named above." |
| Product Testing | Supports equivalence | "Based on the similarity of composition, product testing results, and intended use, Sperm CryoProtec™ is substantially equivalent to the predicate device named above." |
Study Details (Based on available information in the document)
Given the limited information, assumptions are made where necessary or the item is marked as "Not specified."
-
Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document only mentions "clinical trials and comparative testing."
- Data Provenance: Not specified. It does not mention country of origin or whether it was retrospective or prospective.
-
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 detail how individual data points were evaluated or by whom.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not specified.
-
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:
- MRMC Study: Not applicable. This device is a cryopreservative, not an AI or imaging diagnostic device that would involve "human readers."
- Effect Size: Not applicable.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable as this is a medical chemical/biological product, not an algorithm. The "performance" refers to the product's ability to protect sperm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the effectiveness of a cryopreservative would typically involve objective laboratory parameters following cryopreservation and thawing, such as sperm motility, viability, and perhaps success rates in assisted reproductive technologies (ART) if clinical outcomes were part of the trials. The document broadly states "clinical trials and comparative testing," implying that relevant metrics were measured and compared to the predicate device.
-
The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set in the conventional sense. The "training" here would be product development and formulation.
-
How the ground truth for the training set was established: Not applicable. (See #7).
§ 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.