(86 days)
Bovine Serum Albumin ((BSA) is intended for those assisted reproductive procedures that require the use of a protein supplement. In particular, BSA is intended for use during in vitro fertilization, during in vitro embryo culture to the desired stage of embryo development, and for the cryopreservation of human embryos.
Bovine Serum Albumin, Fraction V 10% solution consists of Bovine Serum Albumin from United States source animals (10mg/mL) in a sterile saline solution. Bovine Serum Albumin, Fraction V Powder consists of BSA from United States source animals.
The provided text describes a medical device, Bovine Serum Albumin (BSA), not an AI/ML powered device. Therefore, many of the requested criteria related to AI/ML device studies (such as sample size for test set, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set size, and how ground truth was established for training data) are not applicable.
However, I can extract information regarding the acceptance criteria and the study that proves this particular device meets those criteria:
Device: Bovine Serum Albumin (BSA)
Intended Use: For use in assisted reproductive procedures (in vitro fertilization, embryo culture, and cryopreservation of human embryos) that require protein supplementation.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (implicitly derived from "Notice of Final Rule, 63 FR 48428, Docket number 97N-0335") | Reported Device Performance (from "Performance Data" and "Additional Information" sections) |
|---|---|
| Functionality for intended use: Support embryonic growth | Assured by Mouse Embryo Assay prior to release to market. The product has been used in clinical settings for years and is a standard protein supplement. |
| Absence of toxic components: Non-toxic for embryonic growth | Assured by Mouse Embryo Assay prior to release to market. |
| Sterility | Tested as a condition of release. |
| Endotoxin levels | Tested as a condition of release. |
| Suitability for intended use, meeting criteria of Notice of Final Rule. | Performance testing and review of historical professional literature concluded suitability. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in terms of number of embryo cultures. The "Mouse embryo assay" ("MEA") is a biological test, and typically involves a certain number of embryos, but the specific quantity is not mentioned.
- Data Provenance: Not explicitly detailed. The BSA itself is stated to be from "United States source animals." The clinical use mentioned is broad ("in a variety of clinical settings"), without specific countries or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is a biological product, and its performance is evaluated by a standardized biological assay (Mouse Embryo Assay) rather than expert interpretation of a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a biological product, and its performance is evaluated by a standardized biological assay.
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 not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/ML device. The "standalone" performance here would refer to the product's direct effect on embryos, which is tested via the Mouse Embryo Assay.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this product's performance is established through functional biological assay (Mouse Embryo Assay) and analytical testing (endotoxin, sterility). The Mouse Embryo Assay measures the ability of the product to support embryo development and ensures the absence of toxicity.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device, so there is no "training set."
§ 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.