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The CryoIQ Multi LINE are reusable devices intended to destroy tissue during surgical procedures by applying extreme cold.

The CryoIQ devices consist of a unit body with a lever and an applicator (capillary tube, tip). A disposable cartridge filled with nitrous oxide (N₂O, laughing qas) will be attached to the unit body by slightly screwing into it. The cartridge has a build-in valve for safety storage and release of the gas. The CryoIQ designed to dispense a continuous stream of liquid nitrous oxide when actuated by pressing the lever. The device functions by means of heat evaporation upon phase transition where the nitrous oxide is applied to the treatment area by means of the applicator (capillary tube, tip) at a constant temperature of -89°C/-128°F (cold performance) followed by evaporation. Physicians or medical professionals can use the gas in procedures requiring the destruction of tissue using the extreme cold of nitrous oxide (-89°C/-128°F).

I am sorry, but the provided text does not contain information about acceptance criteria or specific studies that prove the device meets these criteria in the context of an AI/ML medical device.

The document is a 510(k) premarket notification for a Cryosurgical unit and accessories (CryoIQ MULTI LINE). This is a traditional medical device, not an AI/ML device.

Therefore, I cannot extract the following requested information:

• A table of acceptance criteria and the reported device performance.
• Sample size used for the test set and the data provenance.
• Number of experts used to establish the ground truth for the test set and their qualifications.
• Adjudication method for the test set.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs without AI assistance.
• If a standalone (algorithm only without human-in-the-loop performance) was done.
• The type of ground truth used.
• The sample size for the training set.
• How the ground truth for the training set was established.

The document discusses performance testing for the CryoIQ MULTI LINE based on the standard ASTM: F882-84 for Cryosurgical Medical Instruments, which includes:

• Freezing Effect Evidence
• PPM test report
• Mechanical Integrity test report

It concludes that the subject devices meet the requirements of the standard and that the freezing effect is comparable to the predicate device due to using the same technology. However, these are mechanical and performance tests for a cryosurgical device, not AI/ML performance metrics.

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