(144 days)
Complete Modified Ham's F-10 Medium and Complete Modified Ham's F-10 Medium HEPES are intended for use in assisted reproductive technology procedures that involve the manipulation of gametes or embryos. Specifically, Complete Modified Ham's F-10 Medium is intended for use as a culture medium for the embryo after fertilization, when used with an incubator, and as a medium to support in vitro fertilization. Complete Modified Ham's F-10 Medium HEPES is intended for use as a sperm-processing medium in washing or ICSI® procedures, as an oocyte retrieval medium, for transport of the embryo, and as a support medium for implantation of the embryo. Both Modified Ham's F-10 Medium and Modified Ham's F-10 Medium HEPES are supplied to customers as liquid basal media and 50X lyophilized supplements. Users are instructed to reconstitute the lyophilized supplement with the basal liquid media to form the complete media at the time of use.
Modified Ham's F-10 Basal Medium and Modified Ham's F-10 Basal Medium HEPES are synthetic, defined media intended for use in assisted reproductive technology procedures. They are designed to be used with a 50X lyophilized supplement. Reconstitution of the supplement yields a complete medium. Modified Ham's F-10 Medium differs from Modified Ham's F-10 Medium HEPES by the buffer system used. Modified Ham's F-10 Medium uses a sodium bicarbonate buffering system, and is appropriate for those procedures requiring the use of a carbon dioxide atmosphere during incubation. Modified Ham's F-10 Medium HEPES utilizes a HEPES ([4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid]) buffer. This buffering system provides maintenance of physiological pH (7.2 to 7.4), and does not require the use of a carbon dioxide incubator.
Here's a breakdown of the acceptance criteria and the study information based on the provided text:
Acceptance Criteria and Device Performance Study
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional for intended use: Support embryonic growth | "Assayed by mouse embryo assay prior to their release to market. This assay assures that the product is both functional for its intended use, the support of embryonic growth..." |
| Absence of toxic components: | "...and that no toxic components are present in the formulation." |
| 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 Modified Ham's F-10 Medium and Modified Ham's F-10 Medium HEPES are suitable for their intended use, and meet the criteria outlined in the Notice of Final Rule, 63 FR 48428, Docket number 97N-0335." |
| Endotoxin testing: | "Mouse embryo testing will be performed as a condition of release for these products, as well as endotoxin and sterility testing." |
| Sterility testing: | "Mouse embryo testing will be performed as a condition of release for these products, as well as endotoxin and sterility testing." |
2. Sample Size Used for the Test Set and Data Provenance
The document refers to a "mouse embryo assay" as the primary performance test.
- Sample Size: The exact sample size (number of mouse embryos or assays) for the test set is not specified in the provided text. It only mentions that the assay is performed "prior to their release to market" and "as a condition of release for these products."
- Data Provenance: The document does not explicitly state the country of origin or whether the data is retrospective or prospective. Given it's a pre-market release assay, it would inherently be prospective data collection for each batch/lot of the product. The location of Irvine Scientific (Santa Ana, CA) suggests the testing would likely occur in the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not describe the use of human experts to establish ground truth for the mouse embryo assay. The assay itself is the objective measure of "support of embryonic growth" and "absence of toxic components."
4. Adjudication Method for the Test Set
Not applicable. The mouse embryo assay is a laboratory-based, objective test, not requiring human adjudication in the context of this study description.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The document focuses on the performance of the media itself, not comparing human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a culture medium, not an algorithm or AI system. The performance study described is the "mouse embryo assay," which tests the biological efficacy of the medium.
7. The Type of Ground Truth Used
The ground truth used is based on biological outcomes/functional performance as measured by the mouse embryo assay. The criteria are:
- Ability to support embryonic growth.
- Absence of toxic components.
Additionally, compliance with the "Notice of Final Rule" implies an regulatory/legal ground truth.
8. The Sample Size for the Training Set
Not applicable. This device is a culture medium, not a machine learning model, so there is no concept of a "training set" in the context of this document.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of 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.