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Vit Kit™ - Freeze is intended for ultra-rapid freezing and containment of human blastocysts for Assisted Reproductive Technology (A.R.T.) procedures. This kit is designed for use with Irvine Scientific's Blastocyst Vitrification Thaw Kit (Vit Kit™ - Thaw, Catalog #90137) for optimal recovery of specimens.

Vit Kit™ - Thaw is intended for the recovery of human blastocysts that have undergone ultra-rapid freezing and containment using Irvine Scientific's Blastocyst Vitrification Freeze Kit (Vit Kit™ - Freeze, Catalog #90133) for Assisted Reproductive Technology (A.R.T.) procedures.

The five (5) media that comprise the two kits, Vit Kit™ - Freeze and Vit Kit™ - Thaw are all based upon the modified formulation of Medium 199. The Medium 199 is HEPES buffered and contains 20% (v/v) SSS, 35μg/mL gentamicin and varying concentrations of DMSO, EG and sucrose. The two (2) freeze, ES and VS, media in the Vit Kit™ - Freeze are intended to be used sequentially, for the preparation for, and cryopreservation of, human blastocysts. ES is used in preparation for freezing and contains 7.5 % (v/v) DMSO and EG. VS is to be used during cryostorage and contains 15% (v/v) DMSO and EG and 0.5M sucrose.

The three (3) thaw, TS, DS and WS, media in the Vit Kit™ - Thaw are also intended for sequential use in the thawing and recovery of cryopreserved human embryo. The first medium used in the thawing process, TS, contains 1.0M sucrose. The second medium, DS, contains 0.5M sucrose. The third medium, WS, contains no sucrose.

The provided text describes a 510(k) premarket notification for the "Vit Kit™ - Freeze" and "Vit Kit™ - Thaw" devices, which are cryopreservation and thawing media for human blastocysts in Assisted Reproductive Technology (ART) procedures.

However, the document does not contain the specific details regarding acceptance criteria for device performance or a detailed study report that proves the device meets such criteria in a quantitative sense. The submission focuses on describing the device, its intended use, and its technological characteristics in comparison to a predicate device.

The "Conclusion" section mentions "results from the field testing (refer to Appendix D) of these products along with the peer reviewed articles (refer to Attachment 1 and Attachment 2)," which are cited as demonstrating that the kits "are suitable for their intended use, and meet the criteria outlined in the Notice of Final Rule, 63 FR 48428, Docket number 97N-0335."

Without the content of Appendix D, Attachment 1, and Attachment 2, it is impossible to fully answer the request for quantitative acceptance criteria and study details. Based solely on the provided text, here's what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document explicitly states that "results of all release assays performed will be reported on a lot-specific certificate of analysis," and that "Endotoxin, mouse embryo freezing and recovery assay performance and sterility tests will be performed as a condition of release for these products." However, the specific acceptance thresholds or the actual performance values from the "field testing" (Appendix D) or "peer reviewed articles" (Attachment 1 and 2) are not included in the provided text.

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

• Sample Size: Not specified in the provided text. The term "field testing" is used, implying real-world application, but no numbers are given.
• Data Provenance: Not explicitly stated (e.g., country of origin). The term "field testing" suggests prospective testing, but it's not confirmed. The "peer-reviewed articles" could be retrospective or prospective and from various locations.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication method for the test set:

• Not specified.

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 not applicable. The device is cryopreservation and thawing media, not an AI software or a device that involves human "readers" or human-in-the-loop performance in the context of an MRMC study as commonly understood in medical imaging or diagnostic AI.

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

• No, this is not applicable. The device is a biological media, not an algorithm.

7. The type of ground truth used:

• The "ground truth" for the device's performance would likely be based on biological outcomes related to blastocyst viability, survival, and developmental potential after cryopreservation and thawing (e.g., percentage of surviving blastocysts, re-expansion rates, implantation rates in ART procedures). However, the specific metrics and how they were established (e.g., expert consensus, pathology, clinical outcomes data) are not detailed within the provided text. The mentions of "field testing" and "peer reviewed articles" suggest that clinical or laboratory outcome data were used, but the specifics are absent.

8. The sample size for the training set:

• Not applicable. This device is a biological media, not a machine learning model, so there is no "training set."

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

• Not applicable. As above, no training set for a machine learning model.

In summary, the provided document serves as a 510(k) summary and indicates that supporting data (Appendix D, Attachments 1 and 2) were submitted to demonstrate substantial equivalence and suitability for intended use. However, these supporting documents, which would contain the quantitative acceptance criteria and study specifics, are not included in the provided text.

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