(70 days)
Refrigeration Medium – Test Yolk Buffer and Freezing Medium – Test Yolk Buffer with Glycerol are intended for use in assisted reproductive technology procedures that involve the manipulation and storage of semen samples prior to use in in vitro fertilization and other similar treatments. Refrigeration Medium -Test Yolk Buffer is specifically designed for to protect semen samples during refrigerated storage, while Freezing Medium – Test Yolk Buffer with Glycerol is intended to be used as a cryopreservative of semen samples.
Freezing Medium – Test Yolk Buffer (TYB) with Glycerol and Refrigeration Medium – Test Yolk Buffer (TYB) are synthetic, defined media intended for use in assisted reproductive technology procedures that specifically require donor semen samples to be stored at low temperatures, either under refrigeration or frozen.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Irvine Scientific Freezing Medium and Refrigeration Medium:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated Requirements) | Reported Device Performance (How the device meets criteria) |
|---|---|
| Ensures product functions appropriately | "Assayed by a sperm recovery assay prior to release to market." "The products have become the standard media used for the low temperature storage and preservation of human semen samples." |
| No toxic components are present in the formulation | "Assayed by a sperm recovery assay prior to release to market." (Implied, as toxicity would affect sperm recovery) "Endotoxin and sterility testing." |
| Suitable for intended use: cryopreservation of human semen samples (Freezing Medium) | "Used in a variety of clinical settings, for their intended use for a number of years." "The products have become the standard media used for the low temperature storage and preservation of human semen samples." "Sperm recovery assay will be performed as a condition of release." |
| Suitable for intended use: protection of human semen samples during refrigerated storage (Refrigeration Medium) | "Used in a variety of clinical settings, for their intended use for a number of years." "The products have become the standard media used for the low temperature storage and preservation of human semen samples." "Sperm recovery assay will be performed as a condition of release." |
| Meets criteria outlined in Notice of Final Rule, 63 FR 48428, Docket number 97N-0335 | "The conclusion from performance testing, as well as a review of the historical information contained in professional literature shows that TYB Freezing Medium with Glycerol and TYB Refrigeration Medium are suitable for their intended use, and meet the criteria outlined in the Notice of Final Rule..." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "a sperm recovery assay" that will be performed, but not the sample size for this assay or for the "variety of clinical settings" where the products were used.
- Data Provenance: The document refers to "historical information contained in professional literature" and "used in a variety of clinical settings, for their intended use for a number of years." This suggests the data is retrospective, gathered over time from clinical use, rather than from a dedicated prospective study for this 510(k) submission. No specific country of origin is mentioned, but "clinical settings" implies real-world use.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- This document does not describe the use of experts to establish a "ground truth" for a specific test set in the modern sense of algorithm evaluation. The assessment relies on the product's historical clinical use and a standard laboratory assay (sperm recovery).
4. Adjudication Method for the Test Set
- Not applicable. There's no mention of a human expert adjudication process for a test set. The evaluation is based on product performance in clinical use and laboratory assays.
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. This is a submission for a reproductive media product, not an AI or imaging device that would involve human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is not an algorithmic device. The "performance data" refers to the biological function of the media.
7. The Type of Ground Truth Used
- The "ground truth" for the performance of these media is established by the biological outcome of sperm viability and recovery after exposure to the medium, as measured by a "sperm recovery assay," and indirectly by their successful use in "clinical settings" over time leading to them becoming "standard media." It also relies on compliance with a regulatory standard (Notice of Final Rule, 63 FR 48428).
8. The Sample Size for the Training Set
- Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. There is no training set 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.