(94 days)
Phenol Red Stock Solution is intended for use at 1X (5mg/L) concentration in media without phenol red to serve as a visual aid to monitor the pH in vitro in a control dish (not intended for culture).
A 100X concentrated solution of phenol red in normal saline will be provided in 20 mL fill using 30mL vials, to complement the phenol red free media for gamete and embryo culture.
Here's a breakdown of the acceptance criteria and study information for the Irvine Scientific Phenol Red Stock Solution, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Supports embryonic growth | Assayed by mouse embryo assay prior to release, ensuring product supports embryonic growth |
| No toxic components present | Assayed by mouse embryo assay prior to release, ensuring no toxic components |
| Meets criteria outlined in Notice of Final Rule, 63 FR 48428, Docket number 97N-0335 | Performance testing and review of historical professional literature confirm suitability for intended use and meeting criteria. |
(Note: The specific quantitative criteria of the "Notice of Final Rule" are not detailed in the provided text, only that the device meets them.)
Study Details
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: The exact sample size for the mouse embryo assay (number of embryos, number of replicates) is not specified in the provided document. It only states "assayed by mouse embryo assay."
- Data Provenance: Not explicitly stated, but as the company is Irvine Scientific in Santa Ana, CA, and the submission is to the FDA, it is highly likely the data is from the USA and is prospective (conducted specifically for product release testing).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: This information is not provided. The mouse embryo assay is a laboratory test, not typically reliant on expert consensus for interpreting individual results but rather on established biological protocols and scientific interpretation.
- Qualifications of Experts: This information is not provided.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: None explicitly mentioned as this is a laboratory assay with pre-defined endpoints (e.g., embryonic development stages, viability).
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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:
- MRMC Study: No. This device is a chemical solution (Phenol Red Stock Solution) and not an AI-powered diagnostic or imaging device. Therefore, a MRMC study is not applicable.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Study: Not applicable. This is a laboratory reagent, not an algorithm. The "performance" is its biological effect in a mouse embryo assay, which is a standalone test of the product itself.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground Truth: The ground truth is based on the biological outcome of the mouse embryo assay. This typically involves assessing embryonic development (e.g., cleavage to blastocyst stage) and viability as per established scientific protocols for embryo toxicity testing. This is a form of outcomes data in a controlled biological setting.
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The sample size for the training set:
- Training Set Sample Size: Not applicable. This device is a chemical reagent, not a machine learning model, so there is no concept of a "training set" in this context. The mouse embryo assay is a release test.
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How the ground truth for the training set was established:
- Training Set Ground Truth Establishment: Not applicable for the reasons stated above.
§ 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.