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The C2 CryoBalloon™ Focal Ablation System is intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications.

The subject device is the Catheter used as part of a cryosurgical unit with a nitrous oxide cooled balloon that is compatible with commercially available endoscopes with a minimum working channel inner diameter (ID) of 3.7 mm and maximum length of 100 cm. The subject Catheter is part of a cryosurgical system comprised of three components including a Catheter (sterile, single use), Controller (non-sterile, reusable), and Cartridge (non-sterile, single use). The subject device is used to ablate unwanted tissue by application of extreme cold. The balloon at the distal end of the Catheter is comes in contact with tissue and is inflated with nitrous oxide. Tissue is visualized through the pre-inflated balloon, and the treatment site is selected is by adjusting the endoscope and Controller. The nitrous oxide spray cools the balloon to ablate the unwanted tissue, and the nitrous oxide exhausts through the Controller.

This document is a 510(k) summary for the C2 CryoBalloon™ Focal Pear Catheter, indicating FDA clearance based on substantial equivalence to a predicate device (CryoBalloon Focal Ablation System, K131523). It does not contain a study proving the device meets acceptance criteria in the sense of a clinical trial with performance metrics against a pre-defined acceptance threshold.

Instead, the document details a design verification testing approach to establish substantial equivalence.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria with corresponding performance results in the format typically seen for algorithm performance. Instead, it states that "Design verification testing, based on results of risk analysis, was performed on the C2 CryoBalloon™ Focal Ablation System to evaluate the physical, reliability, and safety specifications."

The performance data mentioned are:

• Dimensional verification
• Balloon integrity
• Balloon fatigue
• Bond and connector tensile strength and integrity

The "reported device performance" is summarized by the conclusion that "The performance data results demonstrate that the subject C2 CryoBalloon™ Focal Ablation System should perform as intended in the specified use conditions and should perform comparably to the legally marketed predicate that is currently marketed for the same intended use."

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

Not applicable. This is a medical device clearance document based on engineering and design verification testing, not a study involving human or image data. The testing was likely conducted in a lab environment.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. Ground truth in the context of expert consensus on medical images or clinical outcomes is not relevant here. The "ground truth" for the engineering tests would be established by validated test methods and specifications.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods (e.g., 2+1) are for cases where human experts review and agree on a consensus label, typically in image interpretation studies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. This device is a cryosurgical tool, not an AI or imaging interpretation device that would involve human readers.

6. Standalone Performance Study:

A "standalone" performance study in the context of an algorithm's performance without human intervention is not applicable. This document describes the performance of a physical medical device. The "design verification testing" could be considered a form of standalone performance evaluation for the device's functional integrity.

7. Type of Ground Truth Used:

The "ground truth" for this type of device clearance is based on engineering specifications, established test methods, and industry standards for physical, reliability, and safety evaluations of medical devices.

8. Sample Size for the Training Set:

Not applicable. This is not an AI or machine learning device that requires a training set of data.

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

Not applicable, as there is no training set mentioned for this device.

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