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The Kryo ART brand of controlled rate freezers are intended to be used to freeze gametes or embryos at a user determined rate.

The Kryo ART range of controlled rate freezers have been specifically designed and configured for use in the assisted reproduction field. The Kryo ART range of controlled rate freezers are available in three chamber sizes depending on the number of samples to be frozen; 1.7 liters, 3.3 liters and 16 liters. All models incorporate the critical features expected from a high specification biological chamber and the -180 degrees C to +40 degrees C temperature range allows flexibility for a wide range of applications and protocols. All of the chamber sizes are controlled by the MRV controller system, which has been created to offer multiple protocols while remaining simple to program and operate. All systems include power failure protection, which allows the controller to continue monitoring during mains power failures. All software is designed, developed and maintained in accordance with the Company's internal procedures. These procedures form part of the full Quality System, which is approved to ISO 9001:1994, ISO 13485:1996 and EN 46001:1996. Performance testing is complete. Units were tested according to a specific protocol. Testing demonstrates the functional suitability of the Kryo ART Controlled Rate Freezer for their intended purpose. The Kryo ART brand of controlled rate freezes are intended to freeze gametes or embryos at a user determined rate.

The provided text is a 510(k) summary for the Kryo ART Controlled Rate Freezer. It outlines the device's classification, intended use, and substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria, detailed study designs, or performance data beyond a general statement that "Performance testing is complete. Units were tested according to a specific protocol. Testing demonstrates the functional suitability of the Kryo ART Controlled Rate Freezer for their intended purpose."

Therefore, I cannot provide the requested information in the format specified because the document does not contain that level of detail.

The document indicates that the device met the requirements for a finding of substantial equivalence to the predicate device K021042, CryoMed IVF Controlled Rate Freezer, marketed by Thermo Forma, Inc. The basis for this equivalence is stated as "basic design, materials, intended use and performance characteristics."

Without further documentation, it is not possible to describe:

1. A table of acceptance criteria and the reported device performance: This information is not present.
2. Sample size used for the test set and the data provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.
4. Adjudication method: Not specified.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not specified, and unlikely for this type of device.
6. If a standalone performance study was done: The document states "Performance testing is complete. Units were tested according to a specific protocol," implying standalone testing, but no details are provided.
7. The type of ground truth used: Not specified.
8. The sample size for the training set: Not applicable as this is a physical device, not an AI/ML algorithm.
9. How the ground truth for the training set was established: Not applicable.

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