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The Vitrification Solution Set is intended for use in the virification of oocytes (MI), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.

The Warming Solution Set is intended for use in the thawing of vitrified occytes (MI), pronuclear (PN) zygotes through day 3 cleavage stage embryos, and blastocyst stage embryos.

The Vitrification Solution Set and Warming Solution Set are intended for freezing and thawing oocytes and embryos for use in assisted reproductive technology (ART) procedures.

The Vitrification Solution Set consists of two media components, the Equilibration Solution (ES) and the Vitrification Solution (VS). The Warming Solution Set consists of three media components, the Thawing / Warming Solution (TS), Diluent Solution (DS), and Washing Solution (WS). All media are provided in 1.8 ml polypropylene vials with a polyethylene cap. All media in both sets undergo aseptic filtration and are single-use only.

The provided text describes the 510(k) premarket notification for a medical device called "Vitrification Solution Set and Warming Solution Set." This document focuses on demonstrating that the new device is substantially equivalent to a legally marketed predicate device. The information details non-clinical performance testing conducted to support this claim, but it does not involve a study with human subjects, nor does it establish ground truth from human experts, or conduct MRMC studies relating to human reader performance with or without AI assistance.

Therefore, I cannot provide details on the specific aspects of acceptance criteria and study design that involve human readers, expert consensus for ground truth on human data, or MRMC studies, as the provided document pertains to in-vitro reproductive media testing rather than a diagnostic or therapeutic device requiring such evaluation for human use.

However, I can extract the acceptance criteria and performance data for the device itself based on the non-clinical testing:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are established for the characteristics of the vitrification and warming solutions themselves rather than for a diagnostic output interpreted by humans. The performance demonstrated that these criteria were met.

Note: The studies described here are non-clinical performance tests for an in-vitro reproductive media, not clinical studies involving human patients or the evaluation of an AI algorithm's diagnostic performance. Therefore, many of the requested points are not applicable to the provided document.

Here's an explanation of the non-applicable points from your request:

2. Sample size used for the test set and the data provenance:

• The "test set" here refers to batches of the manufactured vitrification and warming solutions used for quality control and shelf-life testing. The document doesn't specify the exact number of batches or samples tested for each criterion, but it implies standard QC procedures.
• Data provenance: Not explicitly stated, but assumed to be from ECMPC, LLC's internal lab testing in the US, as they are the submitter. The studies are non-clinical (laboratory-based), not based on retrospective or prospective patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. Ground truth in this context is established by laboratory measurements (e.g., pH meters, osmometers, bacterial cultures, microscopic evaluation in MEA) and adherence to established standards (USP, ASTM, ISO). There are no human experts establishing "ground truth" in the way radiologists would for medical images.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used in medical imaging studies where there's human interpretation of data and potential disagreement. Here, the "truth" is determined by objective scientific measurements and established pass/fail criteria.

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:

• Not Applicable. This is not a study of human reader perception or AI assistance. It's a performance evaluation of a chemical solution via in-vitro assays.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not Applicable. There is no algorithm being tested in this submission. The device is a chemical solution.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• The "ground truth" for this device's performance is based on pre-defined laboratory assay results and specifications as per recognized standards (e.g., USP monographs for sterility, endotoxins, pH, osmolality; FDA guidance for Mouse Embryo Assay; ASTM standards for transportation).

8. The sample size for the training set:

• Not Applicable. There is no "training set" as this is not an AI or machine learning model.

9. How the ground truth for the training set was established:

• Not Applicable. No training set exists.

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