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The SurgiFrost® XL Cryosurgical Device and Cryosurgical Console are intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. The SurgiFrost® XL Cryosurgical Device and Cryosurgical Console freezes the target tissue and blocks the electrical conduction pathways by creating an inflammatory response or cryonecrosis.

The SurgiFrost® XL Cryosurgical Device and Cryosurgical Console are intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. The SurgiFrost® XL Cryosurgical Device and Cryosurgical Console freezes the target tissue and blocks the electrical conduction pathways by creating an inflammatory response or cryonecrosis. The SurgiFrost® XL Cryosurgical Device and Cryosurgical Console and accessories act together as a System. The system is composed of the following components: Cryosurgical Control Panel and Power Cord, Cryosurgical Console, Tank Carrier, Gas Tank Regulator and Wrench, Gas Hose, SurgiFrost® XL Cryosurgical Device (Single Use), Footswitch (optional). The SurgiFrost® Cryosurgical System consists of a compact, easy-to-operate Cryosurgical Console and associated accessories that include SurgiFrost® XL Cryosurgical Probe to deliver cold temperatures to the targeted tissue. The control console operates off standard 120/230 VAC (60/50 Hz) wall power and utilizes inert argon gas. The Cryosurgical Console controls a single-use, disposable SurgiFrost Cryosurgical Probe.

The provided text describes a 510(k) summary for a medical device seeking substantial equivalence to existing devices. It does not contain information about specific acceptance criteria or a study designed to prove the device meets those criteria.

The document states:

• Intended Use: "The SurgiFrost® XL Cryosurgical Device and Cryosurgical Console are intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. The SurgiFrost® XL Cryosurgical Device and Cryosurgical Console freezes the target tissue and blocks the electrical conduction pathways by creating an inflammatory response or cryonecrosis."

Regarding "Performance Testing," the document only says:

• "Information submitted in this premarket notification for the SurgiFrost® XL information of Olyosurgical Console is substantially equivalent to the predicate devices listed."

This indicates that the submission relies on the device's substantial equivalence to predicate devices rather than providing new performance testing data against specific acceptance criteria. Therefore, most of the requested information cannot be extracted from the provided text.

Here is a summary of what can be inferred from the text, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance: This information is not provided in the document. The submission hinges on substantial equivalence to predicate devices, not on meeting new, specified performance criteria with new data.

2. Sample size used for the test set and the data provenance: This information is not provided. The document does not describe any specific testing with a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided. As no test set is described, no ground truth establishment is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: This information is not provided.

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: This is not applicable/not provided. The device is a cryosurgical system, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is not applicable/not provided. The device is a cryosurgical system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): This information is not provided.

8. The sample size for the training set: This information is not provided. The document does not describe any machine learning or AI components that would require a training set.

9. How the ground truth for the training set was established: This information is not provided.

In conclusion, the 510(k) submission for the SurgiFrost® XL Cryosurgical Device and Cryosurgical Console does not describe specific acceptance criteria and a study to meet them. Instead, it argues for substantial equivalence to existing predicate devices, implying that the safety and effectiveness are established by comparison to already approved devices.

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