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AtriCure's cryoICE® cryoXT™ cryoablation probes are intended for use to temporarily block pain by ablating peripheral nerves performed by freezing target tissues, creating an inflammatory response (cryonecrosis).

The cryoICE® cryoXT™ probe is a sterile, single-use device designed to enable cryoablation of target nerves by allowing surgeons to surround exposed peripheral nerves with its blunt prong-shaped distal tip, and in conjunction with an AtriCure cryoICE BOX (ACM), temporarily freeze the tissue in contact with the probe tip by circulating a cryogenic agent, nitrous oxide, through the device. cryoXT is offered in one single probe length of approximately 11" (28 cm) long. The device has a flexible tubeset that consists of a gas supply tube and exhaust tube, a handle, a malleable probe which is covered by an insulating sheath and has a prong-shaped distal tip at the distal end.

The provided FDA 510(k) Clearance Letter for the cryoICE cryoXT cryoablation probe focuses on demonstrating substantial equivalence to predicate devices through comparisons of technological characteristics and non-clinical bench testing. However, it does not contain information about clinical studies with human subjects, AI/algorithm performance, ground truth establishment, or human reader performance. Therefore, I cannot fully address all points in your request.

Based on the provided document, here's the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes several non-clinical bench tests performed to demonstrate performance. The acceptance criteria are stated as being "predetermined" and the device "met the predetermined acceptance criteria." However, specific quantitative acceptance criteria values and the reported quantitative performance data are not provided in this summary. Instead, a qualitative statement of meeting the criteria is given.

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

The document describes non-clinical bench testing. Therefore, there is no "test set" in the context of human data or image data. The "samples" would be individual cryoablation probes or components tested in a lab setting. The document does not specify the number of units/samples used for each of the listed bench tests.

Data Provenance: The data is from non-clinical bench testing conducted by the manufacturer, AtriCure, Inc., based in Mason, Ohio, USA. The document does not indicate if it's retrospective or prospective, as this distinction typically applies to clinical data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This device clearance is based on non-clinical bench testing and demonstration of substantial equivalence to existing predicate devices. It does not involve interpretation of medical images or diagnostic performance where expert ground truth would be established.

4. Adjudication Method for the Test Set

Not applicable. As stated above, this is non-clinical bench testing, not a study requiring adjudication of human data or expert interpretations.

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

No. The document describes non-clinical bench testing and comparison of technological characteristics to predicate devices. There is no mention of a human-in-the-loop study or MRMC study.

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

No. This is a physical medical device (cryoablation probe), not an AI/algorithm.

7. The Type of Ground Truth Used

For the non-clinical bench tests, "ground truth" would be established by the engineering specifications and performance targets derived from the predicate devices and general safety/performance standards for cryosurgical devices. For example, the "Iceball Performance Test" would likely have a ground truth of a specific iceball size or temperature profile, which is determined by engineering and clinical requirements of the device's function. The results are compared against these predetermined specifications.

8. The Sample Size for the Training Set

Not applicable. This a physical device, and the clearance is based on substantial equivalence and non-clinical bench testing. There is no "training set" in the context of AI or machine learning.

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

Not applicable. As above, no training set is involved.

Summary of what the document does provide regarding acceptance criteria and proof:

The document focuses on demonstrating substantial equivalence of the new cryoICE cryoXT cryoablation probe to its predicate devices (CRYO2 and CRYOS) through a comparative analysis of technological characteristics and a series of non-clinical bench tests.

• Acceptance Criteria Approach: The acceptance criteria for the bench tests were "predetermined," and the device "met the predetermined acceptance criteria ensuring substantial equivalence." The specific quantitative values for these criteria are not disclosed in this summary.
• Proof: The "study" proving the device meets the criteria consists of the successful completion of the following non-clinical bench tests: Cryogenic Performance Test, Iceball Performance Test, Mechanical Reliability Test, Pressure Cycle Withstand Test, Drop Test, Dimensional Verification Test, Biocompatibility Test, and Sterility Test.
• Conclusion: The tests demonstrated equivalence in performance and did not raise any new safety issues, leading to the conclusion that the device is substantially equivalent in fundamental design, technology, function, materials, packaging, sterilization, operating principle, and intended use to the previously cleared predicate devices.

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