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Lyophilized MultiBlast Medium Kit is intended for use in the culture of human embryos from day three (3) to the blastocyst stage of development.

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

The provided document is a 510(k) summary for a medical device called the "Lyophilized MultiBlast Medium Kit," which is an in vitro embryo culture medium. This type of device is a consumable product used in assisted reproductive technology and not an AI/ML powered diagnostic device. Therefore, many of the requested fields regarding acceptance criteria and study parameters for AI/ML devices are not applicable.

Here's an analysis based on the information provided, specifically addressing the aspects that are relevant to this type of device:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The primary "testing" for this biological medium is through mouse embryo assay. The document doesn't specify a sample size for these assays, but states they are performed "prior to release to market" and "as a condition of release for this product." The data provenance is internal to Irvine Scientific (manufacturer). The nature of this testing is prospective, as it occurs for each lot of product before it is released.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The ground truth for a cell culture medium is its functional performance (supporting embryo development and being non-toxic), which is assessed by biological assays (mouse embryo assay) rather than expert interpretation of images or other data.

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

Not applicable. This is not an AI/ML diagnostic device requiring adjudication of human-interpreted results.

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 an AI/ML diagnostic device, and therefore, no MRMC study was performed.

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

Not applicable. This is not an AI/ML algorithm.

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

The ground truth used is biological performance as demonstrated by mouse embryo assays, specifically the ability to support embryonic growth and blastocyst development, and the absence of toxic components. Additionally, historical clinical use data from the predicate device (MultiBlast Medium) contributes to the understanding of the intended use and expected outcomes.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

Summary of the study that proves the device meets the acceptance criteria:

The primary study proving that the Lyophilized MultiBlast Medium Kit meets its acceptance criteria is a mouse embryo assay. This assay is performed on each lot of the product prior to market release. The purpose of this assay is to ensure that the medium is:

1. Functional for its intended use: capable of supporting embryonic growth and blastocyst development in vitro.
2. Non-toxic: free from components that could harm embryos.

Additionally, the submission relies heavily on the substantial equivalence to the predicate device, MultiBlast Medium (K034063). The predicate device has a long history of successful clinical use, being a "standard media used as the second, more complex stage of a sequential media protocol." This historical clinical performance of the predicate device provides strong supportive evidence for the new device's suitability for its intended use, assuming the new device performs equivalently in the mouse embryo assays and other specified release tests (endotoxin and sterility testing).

No large-scale human clinical trial data is presented for this specific device, as the biological assay and substantial equivalence to a clinically established predicate device are deemed sufficient for this product class.

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