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

Cryotec is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 cell or blastocyst stage embryos. It is designed to enable physicians and embryologists to preserve and to store vitrified embryos for assisted reproduction technology procedures. The Cryotec device is composed of a two piece assembly with a polyethylene terephthalate (PET) film sheet attached to a PET handle, and a weighted polyvinylchloride cap to cover the film sheet during handling and storage. During vitrification procedures, the film sheet is loaded with embryos, capped, and immersed in liquid nitrogen. The capped design creates a hermetic seal, resulting in a closed system keeping the film sheet and embryos isolated from liquid nitrogen. The cap is weighted to allow proper alignment in the storage container. The Cryotec device is provided sterile and is for single use only. The Cryotec device has been designed to maintain the integrity of the human embryos the freezing and thawing process.

The provided text describes the 510(k) premarket notification for the Cryotec device. This device is a cryopreservation storage device intended for use in vitrification procedures to contain and maintain human 4-8 cell or blastocyst stage embryos. The submission compares the Cryotec device to a legally marketed predicate device, the Kitazato CryotopUS (K153027), and presents non-clinical performance data to demonstrate substantial equivalence.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states, "Note: The performance testing, Mouse Embryo Assay (MEA), and sterility test are all performed on samples from routine manufactured lots; a Certificate of Analysis is provided with each lot of Cryotec device."

• Sample Size for Test Set: Not explicitly stated as a fixed number. The tests are performed on "samples from routine manufactured lots," implying a continuous quality control process rather than a single fixed test set for premarket submission. No specific number of devices or embryos used for the performance testing or MEA is provided in this document.
• Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given that REPROLIFE Inc. is located in Japan and the correspondent is in the US, the testing could have occurred in either location or a third party.

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 tests performed are primarily laboratory-based performance tests (e.g., physical characteristics, biological assays like MEA, sterility), which typically rely on standardized protocols and instrumental measurements rather than expert human interpretation for "ground truth" in the way a clinical image might. The Mouse Embryo Assay (MEA) results are stated as a percentage of blastocyst development, which is an objective biological outcome rather than an expert's subjective assessment.

4. Adjudication Method for the Test Set

This information is not applicable as the tests described are objective performance measurements (e.g., tensile strength, endotoxin levels, sterility, MEA blastocyst development rate) rather than subjective assessments requiring adjudication to establish ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not conducted or described. The submission focuses on non-clinical performance data to demonstrate substantial equivalence to a predicate device. The document does not mention any studies involving human readers or AI assistance.

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

Not applicable. The Cryotec is a physical medical device (cryopreservation storage device), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

The ground truth for the device's performance is established through objective laboratory measurements and biological assays, as opposed to expert consensus, pathology, or outcomes data from human patients. Examples include:

• Physical measurements (appearance, durability, tensile strength, dimensions).
• Chemical analysis (endotoxin levels).
• Microbiological testing (sterility).
• Biological assay (Mouse Embryo Assay, measuring blastocyst development).

8. The Sample Size for the Training Set

Not Applicable. The Cryotec is a physical medical device and does not involve an algorithm or AI that requires a "training set."

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

Not Applicable. As mentioned above, there is no training set for this type of device.

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