(70 days)
Modified Ham's F-10 with Albumin is intended for assisted reproduction procedures such as the processing or manipulation of human sperm prior to insemination, in vitro fertilization and intracytoplasmic sperm injection (ICSI) procedures.
Modified Ham's F-10 with Albumin is synthetic, defined media composed of a mixture of salts and other physiologically compatible substances. Modified Ham's F-10 with Albumin contains 5 mg/mL of human serum albumin.
The provided text describes a medical device, "Modified Ham's F-10 with Albumin," and its 510(k) submission to the FDA. The submission focuses on demonstrating substantial equivalence to a predicate device for sperm processing media. The performance data section describes the product's quality control rather than a clinical study evaluating its effectiveness as a diagnostic or AI-powered tool.
Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria, particularly for AI/diagnostic applications, cannot be generated from the given document as it pertains to a reproductive media product, not an AI-powered diagnostic device.
However, I can extract the information related to the quality control and historical use of the product, which serves as its "performance data" in this context.
Here's a breakdown based on the provided text, using the closest applicable interpretations:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (from a quality control perspective) | Reported Device Performance |
|---|---|
| Non-toxic components | Assured by mouse embryo assay (prior to release to market). Satisfactory results allow product release. |
| Endotoxin levels | Tested (as a condition of release). Results reported on lot-specific certificate of analysis. |
| Sterility | Tested (as a condition of release). Results reported on lot-specific certificate of analysis. |
| Suitability for intended use | History of satisfactory use for sperm processing prior to intrauterine insemination. Concluded to be suitable for intended use. |
| Meet criteria outlined in Notice of Final Rule, 63 FR 48428, Docket number 97N-0335 | "Performance testing, as well as a history of satisfactory use... shows that Modified Ham's F-10 with Albumin is suitable for its intended use, and meet the criteria outlined..." |
2. Sample size used for the test set and the data provenance:
- Test Set (for quality control): The "test set" in this context refers to batches of the manufactured medium.
- Sample Size: Not explicitly stated as a number of individual tests, but implies each lot/batch of the product is subjected to the specified assays.
- Data Provenance: Not applicable in the traditional sense of clinical data. It's internal quality control data from Irvine Scientific's manufacturing process.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This document describes quality control assays (mouse embryo assay, endotoxin, sterility) for a culture medium, not a diagnostic device requiring expert interpretation for ground truth establishment.
4. Adjudication method for the test set:
- Not applicable. The "adjudication method" usually refers to reconciling differences in expert opinions for ground truth. Here, results are from laboratory assays and historical use are evaluated against predefined specifications.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. This is not an AI-powered diagnostic device, and thus, an MRMC study comparing human readers with and without AI assistance is not relevant or described.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This product is a biological medium used in assisted reproductive procedures, not an algorithm.
7. The type of ground truth used:
- For quality control: Laboratory assay results (mouse embryo assay, endotoxin, sterility) and historical satisfactory use in clinical settings.
- For the intended effect (purification and concentration of viable sperm): Clinical observation of successful insemination/fertilization outcomes (implied by "history of satisfactory use" and the goal of increasing viable sperm concentration for successful procedures).
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. No training set is involved.
§ 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.