(76 days)
Early Cleavage Medium (ECM) is intended for use in assisted reproductive procedures, which include gamete and embryo manipulation. These procedures include the use of ECM as a culture medium through day 3 of development.
Early Cleavage Medium is a synthetic, defined medium composed of a balanced mixture of salts and other nutrient substances designed to support early stages of embryonic growth (up to three days post-fertilization).
The provided text describes Irvine Scientific's Early Cleavage Medium (ECM) and its 510(k) submission. It details the device's intention, technological characteristics, and performance data.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Functionality in supporting embryonic growth (up to 3 days post-fertilization) | Mouse Embryo Assay: "This assay assures that the product is both functional for its intended use, the support of embryonic growth..." "Parallel mouse embryo studies have been performed on P-1 and ECM to assure the performance of ECM." |
| Absence of toxic components (ensuring safety) | "This assay assures that the product is...that no toxic components are present in the formulation." |
| Compliance with "Notice of Final Rule, 63 FR 48428, Docket number 97N-0335" | "The conclusion from performance testing...shows that Early Cleavage Medium is suitable for its intended use, and meet the criteria outlined in the Notice of Final Rule..." |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify a numerical sample size for the mouse embryo assay test set. It refers to "Parallel mouse embryo studies."
- Data Provenance: Not explicitly stated, however, the studies were conducted by Irvine Scientific in the context of a 510(k) submission to the FDA. The nature of the study (mouse embryo assay) suggests it was prospective for the purpose of demonstrating the device's performance. The country of origin is not explicitly stated, but given Irvine Scientific's location in Santa Ana, CA, and submission to the FDA, it is highly likely to be USA-based.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The "ground truth" for the mouse embryo assay would typically be objective metrics of embryonic development (e.g., number of cells, blastocyst formation rates) under controlled conditions, rather than expert interpretation in the clinical sense.
4. Adjudication method for the test set:
- This information is not provided as the "ground truth" likely relies on objective measurements in the mouse embryo assay. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation of images or clinical outcomes.
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:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices involving human readers. The ECM is an in vitro culture medium.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in a sense. The primary performance evaluation was the mouse embryo assay, which is an objective, standalone test of the medium's ability to support embryo development, without "human-in-the-loop" assistance in interpreting the culture medium's performance itself. It's a lab-based assay, not an algorithm.
7. The type of ground truth used:
- The ground truth used was biological outcome data in a controlled in vitro environment. Specifically, the ability of mouse embryos to grow and develop in the ECM, assessed by the mouse embryo assay. This includes demonstrating functionality and absence of toxicity.
8. The sample size for the training set:
- This information is not provided. The concept of a "training set" is usually applicable to machine learning algorithms. For a chemical culture medium, the "training" involves formulation development and refinement, which isn't typically quantified with a "training set" sample size in the same manner.
9. How the ground truth for the training set was established:
- This information is not provided, and the concept of a "training set ground truth" is not directly applicable to a culture medium in the same way as an AI algorithm. The development of the medium would involve iterative testing and optimization based on known biological principles of embryo development. The "ground truth" for these developmental stages would be established biological norms for mouse embryo viability and progression.
§ 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.