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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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MultiBlast Medium is intended for use as the second stage of a sequential in vitro embryo culture protocol. MultiBlast Medium has been developed to support the growth of human embryos from day three through day five, postfertilization, including blastocyst formation.
MultiBlast Medium is intended for use in the culture of human embryos to the blastocyst stage of development.

MultiBlast Medium 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 reproductive medium called MultiBlast Medium, not a study describing a device's performance against acceptance criteria in the typical sense of a medical device with an algorithm or outcome prediction. The document describes the intended use and technological characteristics of the medium and states that it meets criteria outlined in a Notice of Final Rule (63 FR 48428, Docket number 97N-0335).

Therefore, many of the requested categories in the prompt (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of regulatory submission for an in vitro embryo culture medium.

However, I can extract the information that is present and indicate where information is not available within the provided text.

Acceptance Criteria and Device Performance for MultiBlast Medium

Study Details:

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

   • Sample Size: Not specified. The document mentions a "mouse embryo assay" but does not quantify the number of embryos or assays performed for pre-market release or for the historical information.
   • Data Provenance: The mouse embryo assay is a routine batch release test. The document also refers to "historical information contained in professional literature" and mentions that the product "has been used in a variety of clinical settings, for its intended use, for a number of years," becoming a "standard media." This suggests the efficacy is based on established clinical use and biological principles, rather than a specific prospective clinical trial designed for this 510(k) submission.

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

   • Not Applicable. The "ground truth" for a culture medium revolves around its biological performance (embryo viability and development). This is assessed via standardized biological assays (mouse embryo assay) and historical clinical use data, not through expert consensus on interpretations of complex data like images.

3. Adjudication method for the test set:

   • Not Applicable. No adjudication method is described as the performance is based on biological assays and historical clinical use, not interpretations requiring human reader consensus.

4. 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. This is not a device with an AI component or one that involves human-in-the-loop interpretation.

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

   • No. This is not an algorithmic device.

6. The type of ground truth used:

   • Biological Outcome/Performance: The ground truth is the successful support of embryonic growth and development to the blastocyst stage in vitro, as assessed by a mouse embryo assay and implied by historical clinical use.

7. The sample size for the training set:

   • Not Applicable. This device is a culture medium, not a machine learning algorithm that requires a training set. The "historical information" and "variety of clinical settings" mentioned are more akin to general clinical experience rather than a structured training set for a computational model.

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

   • Not Applicable. (See #7).

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