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Lyophilized Early Cleavage Medium Kit is for use in assisted reproduction technology (ART) that involved the manipulation of gametes or embryos. Specifically, Lyophilized Early Cleavage Medium Kit is intended for use as a culture medium from fertilization through day three (3) of embryo development.

Lyophilized Early Cleavage Medium Kit is a synthetic, defined medium composed of a balanced mixture of salts and other nutrient substances designed to support early stages of embryonic growth (up to three days post-fertilization).

Here's a breakdown of the acceptance criteria and the study information for the Lyophilized Early Cleavage Medium (ECM) Kit, based on the provided document:

Acceptance Criteria and Device Performance

The document describes the performance of the Lyophilized Early Cleavage Medium Kit and its comparison to predicate devices, Early Cleavage Medium (K033462) and P-1 (K983589). The acceptance criteria are implicitly defined by the successful performance in the mouse embryo assay, demonstrating functionality and absence of toxicity comparable to the predicate devices.

Study Details

This submission describes a non-clinical study involving mouse embryo assays.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: The document does not explicitly state the numerical sample size (e.g., number of mouse embryos or assays) used for the test set. It mentions "parallel mouse embryo studies."
• Data Provenance: The studies were conducted by Irvine Scientific Sales Co., Inc., likely in their own facilities, to assess their product's performance prior to release to market. The data is prospective in relation to the submission date, as it was generated to support the 510(k) application. The country of origin is not explicitly stated but can be inferred as the USA, where Irvine Scientific is located and where the submission was made to the FDA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

• This is a non-clinical study involving a mouse embryo assay, not human expert interpretation of data. Therefore, the concept of human experts establishing ground truth for the test set is not applicable in the same way as it would be for, for example, an imaging device. The "ground truth" is based on the biological outcome of embryonic growth in the mouse models.

4. Adjudication Method for the Test Set:

• Not applicable. As a non-clinical, objective biological assay, human adjudication of results is not described. The outcome of the mouse embryo assay (e.g., successful embryonic development, absence of toxicity) is a direct biological observation.

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:

• No. This is a non-clinical study evaluating an in vitro culture medium, not an AI-assisted diagnostic or interpretative device that would involve human readers.

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

• Yes, in essence. The mouse embryo assay is a standalone test of the culture medium's biological performance. It evaluates the medium itself without human intervention in the interpretative process (though human observation and execution of the assay are required). There is no "algorithm" involved in the sense of a digital diagnostic tool.

7. The Type of Ground Truth Used:

• Biological Outcome (Mouse Embryo Development): The ground truth is the observable biological effect of the culture medium on mouse embryos – specifically, their ability to support embryonic growth and the absence of toxic effects, as determined by the mouse embryo assay. This is a direct measure of the product's intended function.

8. The Sample Size for the Training Set:

• This document refers to performance testing for market release and comparison to predicate devices, not a 'training set' in the machine learning context. The studies described are for validation and verification of the product's performance. The previous studies on the predicate devices (K033462 and K983589) could be considered historical data that informed the design and expected performance of the new device, but they are not a training set for an algorithm. The sample size for those historical studies is not detailed here.

9. How the Ground Truth for the Training Set was Established:

• Not applicable as there is no "training set" in the machine learning sense. The ground truth for the performance testing (as described in point 7) was established through the direct biological observation of mouse embryo development in the assay.

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Early Cleavage Medium (ECM) is intended for use in assisted reproductive procedures, which include gamete and embryo manipulation. These procedures include the use of ECM as a culture medium through day 3 of development.

Early Cleavage Medium is a synthetic, defined medium composed of a balanced mixture of salts and other nutrient substances designed to support early stages of embryonic growth (up to three days post-fertilization).

The provided text describes Irvine Scientific's Early Cleavage Medium (ECM) and its 510(k) submission. It details the device's intention, technological characteristics, and performance data.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document does not specify a numerical sample size for the mouse embryo assay test set. It refers to "Parallel mouse embryo studies."
• Data Provenance: Not explicitly stated, however, the studies were conducted by Irvine Scientific in the context of a 510(k) submission to the FDA. The nature of the study (mouse embryo assay) suggests it was prospective for the purpose of demonstrating the device's performance. The country of origin is not explicitly stated, but given Irvine Scientific's location in Santa Ana, CA, and submission to the FDA, it is highly likely to be USA-based.

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 in the document. The "ground truth" for the mouse embryo assay would typically be objective metrics of embryonic development (e.g., number of cells, blastocyst formation rates) under controlled conditions, rather than expert interpretation in the clinical sense.

4. Adjudication method for the test set:

• This information is not provided as the "ground truth" likely relies on objective measurements in the mouse embryo assay. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation of images or clinical outcomes.

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:

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices involving human readers. The ECM is an in vitro culture medium.

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

• Yes, in a sense. The primary performance evaluation was the mouse embryo assay, which is an objective, standalone test of the medium's ability to support embryo development, without "human-in-the-loop" assistance in interpreting the culture medium's performance itself. It's a lab-based assay, not an algorithm.

7. The type of ground truth used:

• The ground truth used was biological outcome data in a controlled in vitro environment. Specifically, the ability of mouse embryos to grow and develop in the ECM, assessed by the mouse embryo assay. This includes demonstrating functionality and absence of toxicity.

8. The sample size for the training set:

• This information is not provided. The concept of a "training set" is usually applicable to machine learning algorithms. For a chemical culture medium, the "training" involves formulation development and refinement, which isn't typically quantified with a "training set" sample size in the same manner.

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

• This information is not provided, and the concept of a "training set ground truth" is not directly applicable to a culture medium in the same way as an AI algorithm. The development of the medium would involve iterative testing and optimization based on known biological principles of embryo development. The "ground truth" for these developmental stages would be established biological norms for mouse embryo viability and progression.

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