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VitriGuard is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 cell and blastocyst stage embryos.

VitriGuard is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 cell and blastocyst stage embryos. It is single-use, disposable, and provided sterile. The device consists of a two-piece polystyrene assembly that includes a hexagonalshaped stick and cap. As part of the vitrification procedure, the embryos to be stored are loaded on the tip, and capped prior to plunging the device in liquid nitrogen and for subsequent storage. The tip has a trough area for loading, maintaining, and securing the embryos. The stick and cap include a taper design that creates a seal when assembled. Markings at the end of the stick and the tip of the device provide visual aid for proper device orientation.

Here's a 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

Note on Cooling/Warming rates: While listed as "Specifications," the document does not explicitly state them as "acceptance criteria" where a threshold needs to be met for the study. They are presented as inherent characteristics of the device. However, for the purpose of demonstrating device performance, they are included here. The MEA is the only one explicitly stated as meeting "predetermined acceptance criteria."

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

• Sample size: Not explicitly stated. The text mentions "VitriGuard devices" and "One-cell mouse embryos" without specifying a number per test.
• Data provenance: Not explicitly stated. However, given it's a pre-market submission, the study was likely conducted specifically for this submission and would be considered prospective for the device's regulatory approval. The study uses mouse embryos, which are a biological model, not human data from a specific country.

3. 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 the Mouse Embryo Assay (MEA) is established based on the biological outcome of embryo development (percent blastocyst formation), not through expert consensus or interpretation of images/data. Therefore, no "experts" were required to establish ground truth in this context.

4. Adjudication method for the test set

Not applicable. As noted above, the ground truth for the MEA is a direct biological outcome, not a subjective assessment requiring adjudication.

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 device is not an AI-assisted diagnostic tool; it is a physical cryopreservation storage device. Therefore, an MRMC study is not relevant.

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

Not applicable. This device is not an algorithm or AI system.

7. The type of ground truth used

The ground truth for the key performance test (Mouse Embryo Assay) was biological outcome data, specifically the successful development of mouse embryos to the blastocyst stage.

8. The sample size for the training set

Not applicable. This device is a physical product, not a machine learning model. There is no "training set" in this context.

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

Not applicable. As there is no training set, there is no ground truth established for it.

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