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Embryo Freeze Media Kit is intended for use in the assisted reproductive procedure, of embryo cryopreservation. The two media kit is designed to protect human cleavage-stage embryos during rapid freezing procedures and during frozen storage.

Embryo Thaw Media Kit is intended for use in the assisted reproductive procedure of thawing frozen cleavage-stage embryos. The three media kit is designed to protect human cleavage-stage embryos during warming and thawing after cryopreservation.

The five media that comprise the two kits, Embryo Freeze Media Kit and Embryo Thaw Media Kit are all based upon the formulation of modified human tubal fluid (K983586). The two media in the Embryo Freeze Media kit are intended to be used sequentially, for the preparation for, and cryopreservation of, human blastocysts. The first medium to be used, F1, which is used in preparation for freezing, contains 1.5M PROH. The second medium, F2, to be used during cryostorage, containing 1.5M PROH and 0.1M sucrose. Both F1 and F2 are also supplemented with human serum albumin (HSA).

The three media in the Embryo Thaw Media kit are also intended for sequential use in the thawing and recovery of cryopreserved human embryo. The first medium used in the thawing process, T1, contains 1.0M PROH and 0.2M sucrose. The second medium, T2 contains 0.5M PROH and 0.2M sucrose. T3 contains 0.2M sucrose. Each T1, T2 and T3 contain HSA. All five media contain gentamicin sulfate.

The media in the Embryo Freeze Media Kit, F1 and F2 are designed to be used sequentially for the preparation of embryos for cryopreservation, and as the protective media during cryostorage. The media in the Embryo Thaw Kit, T1, T2 and T3 are also designed for sequential use, in the thawing and recovery of cryopreserved human embryos. None of the media are intended to contact the patient.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Irvine Scientific Embryo Freeze Media Kit and Embryo Thaw Media Kit:

Given the nature of the product (embryo cryopreservation and thawing media) and the provided text, the "acceptance criteria" discussed are primarily related to general performance and suitability for the intended use, rather than specific numerical performance metrics typical of AI medical devices. The "study" refers to performance evaluations conducted by independent laboratories.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document explicitly states that the studies were performed using "mouse embryos". No specific number of mouse embryos is provided.
• Data Provenance: The studies were conducted by "five independent field laboratories." The country of origin is not specified, but the submission is to the US FDA, implying that some or all of these labs could be in the US. The studies were retrospective in the sense that they were conducted to support the 510(k) submission, but the specific nature of the data collection (e.g., from existing cryopreservation programs or newly designed experiments) is not detailed. Given they use mouse embryos, it's highly likely they were specifically designed experimental studies.

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

This information is not provided in the document. The studies were conducted by "five independent field laboratories," but it's not stated how many experts within these labs assessed the outcomes or their specific qualifications. The "ground truth" here would likely be the assessment of embryo viability, cryosurvival, and developmental potential post-thaw, as determined by standard laboratory protocols and expert observation.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the product, adjudication might involve comparing the performance of the test media to existing control media, potentially through observational assessment by lab personnel.

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 study was not done. This type of study (MRMC) and the concept of "human readers improving with AI assistance" are relevant for AI/radiology devices. This product is a cryopreservation media kit, not an AI diagnostic or assistive tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• No, this is not applicable. This product is a biological medium, not an algorithm. Therefore, the concept of "standalone algorithm performance" does not apply.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" was established by the performance of mouse embryos in terms of freezing, thawing, and recovery using the media kits. This would involve observable outcomes like:

• Survival rate post-thaw.
• Morphology and developmental progression (e.g., re-expansion, hatching potential) of the thawed embryos.
• Comparison of these metrics against a "control freeze/thaw media."

This can be considered laboratory-based observational and biological outcomes data, assessed by the staff of the independent laboratories.

8. The Sample Size for the Training Set

This information is not applicable/provided. The product is a chemical media kit, not an AI model. Therefore, there is no "training set" in the machine learning sense. The formulation would have been developed through R&D and optimization, not machine learning training.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/provided for the reasons stated in point 8.

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