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Blastocyst Medium is intended for use in assisted reproductive technology procedures that include gamete and embryo manipulation. Specifically, Blastoycst is intended for use as an in vitro culture medium from day three through day five of embryo development.

Blastocyst Medium is a synthetic, defined medium, composed of a balance mixture of salts, amino acids, vitamins, minerals and other nutrient substances designed to support embryonic growth and blastocyst development in vitro.

The provided text is a 510(k) summary for the Blastocyst Medium, an in vitro embryo culture medium. It describes the device, its intended use, technological characteristics, and performance data. However, it does not include the details typically found in a study proving a device meets specific acceptance criteria in the format requested.

Specifically, the document focuses on regulatory approval based on substantial equivalence to a predicate device and existing clinical use, rather than a detailed, quantitative study with acceptance criteria and measured performance outcomes as might be found for a new diagnostic or AI-driven medical device.

Therefore, many of the requested categories cannot be filled directly from the provided text because such a detailed performance study, with specific acceptance criteria, sample sizes, expert ground truth establishment, and statistical analysis, is not presented.

Here's a breakdown of what can be gleaned and what is missing, structured as per your request:

Acceptance Criteria and Study for Blastocyst Medium

Based on the provided text, the "acceptance criteria" are implied by the performance characteristics and the regulatory framework of substantial equivalence. The "study" largely refers to historical clinical use and pre-market quality control assays rather than a formal, controlled clinical trial with pre-defined statistical endpoints.

1. Table of Acceptance Criteria and the Reported Device Performance

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

• Sample Size: Not specified in terms of a test set for a formal study. The document mentions "Blastocyst Medium has been used in a variety of clinical settings, for its intended use, for a number of years." This implies a large, undocumented, real-world usage base. For the mouse embryo assay/endotoxin/sterility testing, the sample size is also not specified, likely referring toロット-specific testing.
• Data Provenance: Not explicitly stated beyond "historical information contained in professional literature" and usage in "a variety of clinical settings." No country of origin is specified for these historical applications, and it is entirely retrospective/uncontrolled observation.

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. The decision of suitability is presented as a conclusion based on "performance testing" (likely internal quality control and historical use reviews) and "professional literature," not a formal expert consensus on a specific test set.

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

Not applicable/Not described. There is no mention of a formal test set with adjudicated ground truth establishment.

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 device is an in vitro culture medium, not an AI-assisted diagnostic or imaging device used by human readers. Therefore, an MRMC study and AI assistance are not relevant to this product.

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

Not applicable. This is not an algorithm. The performance is assessed by its ability to support embryo development.

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

The "ground truth" for the device's performance appears to be established through:

• Mouse Embryo Assay (MEA): A biological functional assay.
• Clinical Outcomes (historical): The success of IVF procedures where the medium was used, as inferred from "historical information contained in professional literature" and "variety of clinical settings."
• Regulatory Standards: Compliance with the "Notice of Final Rule, 63 FR 48428, Docket number 97N-0335."

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable.

Summary of Missing Information:

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence. It does not contain the detailed, quantitative efficacy data from a controlled clinical study typically associated with specific acceptance criteria and performance metrics for a novel medical device as would be required for a new diagnostic or AI product. The "performance data" section primarily refers to quality control assays (mouse embryo assay, endotoxin, sterility) and general historical clinical use, rather than a structured study with defined methodologies, sample sizes, and expert panel evaluations.

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