(231 days)
Tyrode's Solution, Acidified is intended to be used in zona drilling procedures, for assisted hatching.
Tyrode's Solution, Acidified is intended for use in assisted reproductive procedures involving the manipulation of embryos. Specifically, Tyrode's Solution, Acidified, is intended for use in zona-drilling procedures.
Tyrode's Solution, Acidified is a synthetic, defined reagent with a pH of 2.1 to 2.5. It is based on the formulation of Tyrode's Solution, a common cell culture medium.
This document describes the validation of "Tyrode's Solution, Acidified" for use in zona-drilling procedures, a chemical reagent, not an AI device. Therefore, many of the requested categories related to AI device evaluation (such as sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and training set information) are not applicable.
Here's an analysis of the provided text based on the request, focusing on the information available for a chemical reagent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| pH Level | 2.1 to 2.5 (verified for each newly manufactured lot) |
| Endotoxin Content | Tested prior to release (implicit assumption: must meet specifications) |
| Sterility | Tested prior to release (implicit assumption: must meet specifications) |
| Suitability for Intended Use | Suitable for its intended use (zona-drilling procedures for assisted hatching) |
| Compliance with Regulatory Citeria | Meets criteria outlined in the Notice of Final Rule, 63 FR 48428, Docket number 97N-0335 |
2. Sample sized used for the test set and the data provenance
- Sample Size: Not explicitly stated for specific testing. Performance data refers to "each newly manufactured lot" being tested for pH, endotoxin, and sterility.
- Data Provenance: Not explicitly stated for specific testing, but implies internal quality control testing for manufactured lots. The document also refers to "historical information contained in professional literature," suggesting external, previously published data or common knowledge about the reagent's use. It has been used in "a variety of clinical settings" for "a number of years."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable as the product is a chemical reagent. Ground truth is established through chemical and biological assays (pH, endotoxin, sterility) and clinical history of use.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable for a chemical reagent. Performance is determined by meeting predetermined specifications for each manufacturing lot.
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 chemical reagent, not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a chemical reagent, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- pH Level, Endotoxin, Sterility: Ground truth is established by validated laboratory analytical methods and adherence to predefined specification ranges.
- Intended Use Suitability: Ground truth is established through historical clinical use, professional literature, and the product's established optimal pH range for zona drilling. The statement "the product has become the standard reagent used for chemically mediated zona drilling procedures" indicates long-standing clinical acceptance and outcomes.
8. The sample size for the training set
- Not applicable. This is a chemical reagent, not an AI device that undergoes 'training'.
9. How the ground truth for the training set was established
- Not applicable.
§ 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.