(164 days)
Sperm Washing Media is used for sperm washing procedures such as in vitro washing and incubation of sperm prior to gamete intrafallopian transfer (GIFT), in-vitro fertilization (IVF), intrauterine insemination (IUI).
Sperm Washing Media is used for sperm washing procedures such as in vitro washing and incubation of sperm prior to gamete intrafallopian transfer (GIFT), in-vitro fertilization (IVF), intrauterine insemination (IUI). Sperm Washing Media is based upon the formulation of Modified Human Tubal Fluid (HTF).
The provided text describes a 510(k) submission for " Sperm Washing Media." The focus is on regulatory approval and substantial equivalence to existing devices. Therefore, the document does not contain the detailed study information typically requested for AI device performance.
Here's an analysis based on the available information:
Acceptance Criteria and Reported Device Performance
The provided document describes quality control testing for the ** Sperm Washing Media**, not an AI-powered device. Therefore, the "acceptance criteria" and "device performance" relate to the media's biological and physical characteristics, not to diagnostic accuracy metrics like sensitivity or specificity.
| Acceptance Criteria Category | Reported Device Performance (Quality Control Tests) |
|---|---|
| Biocompatibility/Embryotoxicity | Mouse Embryo Assay (MEA) Testing |
| Sterility | Sterility Testing |
| Endotoxin Content | Endotoxin (LAL) Testing |
| Physicochemical Properties | pH and Osmolality tests |
Important Note: The document states, "We will provide clear information to the user about each testing, method, criteria and result in the label and in the Quality Control report enclosed with the product." This indicates specific numerical acceptance criteria and results were likely provided to the FDA in the full submission, but are not detailed within this summary document.
As this is a 510(k) summary for a medical device (sperm washing media) and not an AI-powered diagnostic tool, the following sections (2-9) are largely not applicable or cannot be fully answered from the provided text, as they pertain to AI algorithm validation studies.
2. Sample size used for the test set and the data provenance
Not applicable in the context of an AI device. For the sperm washing media, the "test set" would refer to the lots of media produced. The document doesn't specify the sample size (number of lots or individual samples per lot) for the quality control tests. The provenance of materials used for MEA or other tests is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth in the AI context refers to the correct diagnosis or outcome labeled by experts. For the sperm washing media, "ground truth" would be the verified quality of the media based on standardized laboratory assays. These assays are performed by trained laboratory personnel, not typically "experts" in the sense of clinical specialists establishing diagnostic ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for resolving discrepancies among expert readers in diagnostic AI studies. For laboratory quality control tests, the results are typically objectively measured and compared against predefined specifications, not adjudicated by multiple experts.
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
Not applicable. MRMC studies are used to evaluate the impact of AI on human reader performance. This document concerns a biological media, not an AI system that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This question refers to the performance of an AI algorithm on its own. The device described is a sperm washing media, which is a physical product, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the sperm washing media, the "ground truth" for its quality is established through standardized laboratory assays, such as:
- Mouse Embryo Assay (MEA): This is a biological assay to assess embryotoxicity, indicating the media's suitability for sensitive biological processes. The "ground truth" is typically defined by a certain percentage of embryos developing to a specific stage.
- Sterility Testing: Confirms the absence of microbial contamination.
- Endotoxin (LAL) Testing: Measures the level of bacterial endotoxins.
- Physicochemical tests (pH and Osmolality): Confirms the physical and chemical properties are within specified ranges.
These are objective laboratory measurements, not expert consensus or pathology in the clinical diagnostic sense.
8. The sample size for the training set
Not applicable. There is no AI algorithm being "trained" for this device.
9. How the ground truth for the training set was established
Not applicable. There is no AI algorithm being "trained" for this device.
§ 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.