(67 days)
Embryo Biopsy Medium is intended for use in assisted reproductive technology procedures that involve the manipulation of embryos. Specifically, Embryo Biopsy Medium is intended for use as a temporary culture medium during embryo biopsy blastomere removal procedures.
Embryo Biopsy Medium is a defined media intended for use in assisted reproductive technology procedures. It has been formulated to mimic the composition of the fluid found in human fallopian tubes. Embryo Biopsy Medium uses a combination of HEPES/sodium bicarbonate buffering system and is appropriate for those procedures that do not require the use of a carbon dioxide incubator.
The provided text describes the 510(k) summary for "Embryo Biopsy Medium" and its predicate device. This document is a regulatory submission for a medical device and not a study report detailing acceptance criteria for an AI/ML powered device.
Therefore, most of the requested information (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types for AI models, training set details) is not applicable to this document as it pertains to a traditional medical device (a culture medium) and not an AI-powered diagnostic or predictive tool.
However, I can extract the acceptance criteria and the "performance data" as described for this non-AI device.
Acceptance Criteria and Device Performance for Embryo Biopsy Medium
The provided document describes a traditional medical device (a culture medium), not an AI-powered device. Therefore, the typical acceptance criteria and study methodologies for AI/ML devices (e.g., sensitivity, specificity, MRMC studies, training/test sets, expert ground truth) are not applicable.
Instead, the acceptance criteria for this medical device are based on its biological function and safety.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Safety: Does not adversely impact embryonic growth and is free from toxic components. | Measured by Mouse Embryo Assay (MEA): "Embryo Biopsy Medium is assayed by mouse embryo assay prior to its release to market. This assay assures that the product will not adversely impact embryonic growth and that no toxic components are present." |
| Functional Efficacy (Intended Use): Suitable for its intended use, which is to prevent compaction of cleavage-stage embryos and allow for easier separation and removal of 1-2 blastomeres during embryo biopsy procedures, while maintaining physiological pH in an ambient atmosphere. | Historical Clinical Use: "The equivalent of Embryo Biopsy Medium has been used in a variety of clinical settings for the same intended use for a number of years and has become the standard medium used for the fertilization and growth of human gametes and embryos." |
| pH Maintenance: Contains a combined sodium bicarbonate/HEPES Buffer system to maintain physiological pH in ambient atmosphere (does not require CO2 incubator). | |
| Quality Control: Meets quality control standards for endotoxin and sterility. | Assay for Release: "endotoxin and sterility testing will be performed as a condition of release for this product." |
| Regulatory Compliance: Meets criteria outlined in the Notice of Final Rule, 63 FR 48428, Docket number 97N-0335. | The submission's conclusion states: "The conclusion from performance testing as well as a review of the historical information contained in professional literature shows that Embryo Biopsy Medium is suitable for the intended use and meets the criteria outlined in the Notice of Final Rule, 63 FR 48428, Docket number 97N-0335." |
The following sections are Not Applicable (N/A) as this document describes a traditional medical device, not an AI/ML powered device.
2. Sample size used for the test set and the data provenance
- N/A. The performance data relies on Mouse Embryo Assays and historical clinical use, not a distinct "test set" in the context of an AI/ML study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A. Ground truth as understood for AI/ML models is not directly applicable here. The "ground truth" for this device's performance is its biological effect (non-toxicity, pH maintenance, support of embryonic growth/manipulation) demonstrated through laboratory assays and established clinical practice.
4. Adjudication method for the test set
- N/A. No adjudication method described as it's not a diagnostic reading task.
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
- N/A. This is not an AI-powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is not an AI-powered device.
7. The type of ground truth used
- For the Mouse Embryo Assay (MEA), the ground truth is the observable outcome of embryonic development (e.g., toxicity, normal growth).
- For the pH maintenance, the ground truth is the measured pH value.
- For endotoxin and sterility, the ground truth is the absence or presence of contamination as determined by standard laboratory tests.
- For the intended use claims, the ground truth is established through "historical information contained in professional literature" and "clinical settings for the same intended use."
8. The sample size for the training set
- N/A. This is not an AI-powered device, so there is no training set.
9. How the ground truth for the training set was established
- N/A. This is not an AI-powered 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.