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The C2 CryoBalloon Ablation System is intended for use as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications, to include ablation of Barrett's Esophagus with dysplasia.

The subject and marketed predicate device is a cryosurgical unit with a nitrous oxide cooled balloon that is compatible with commercially available endoscopes with a minimum working channel inner diameter of 3.7 mm and maximum length of 105 cm. The subject device is a cryosurgical system comprised of four components including a Catheter (sterile, single use), Controller (non-sterile, reusable), Foot Pedal (non-sterile, reusable), and Cartridge (non-sterile, single use).

The subject and marketed predicate device is used to ablate unwanted tissue by application of extreme cold. The balloon at the distal end of the Catheter 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 Catheter The nitrous oxide spray cools the balloon to ablate the unwanted tissue, and the nitrous oxide exhausts through the Controller.

The PENTAX Medical C2 CryoBalloon Ablation System is intended for use as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications, to include ablation of Barrett's Esophagus with dysplasia.

Here's an analysis of the provided information regarding acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document is a 510(k) summary for a medical device seeking substantial equivalence to a predicate device. It doesn't present a specific table of quantitative acceptance criteria for clinical performance that would typically be found in a clinical trial report. Instead, the "acceptance criteria" are implied to be the successful completion of various design verification and validation tests, ensuring the device performs as intended and is as safe and effective as its predicate.

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

The document describes preclinical (bench) performance testing, not a clinical study with a "test set" of patients. Therefore, information regarding human sample size and data provenance (country of origin, retrospective/prospective) is not applicable or provided in this 510(k) summary. The testing performed was related to design verification and validation of the device's physical, reliability, and safety specifications.

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

Not applicable, as this document refers to preclinical engineering and safety testing, not a clinical study requiring expert ground truth for patient data.

4. Adjudication Method for the Test Set:

Not applicable for the reasons stated above.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence to a predicate device through preclinical performance testing, not a comparative clinical trial with human readers.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance):

This device is not an AI algorithm. It is a cryosurgical tool. Therefore, the concept of "standalone performance" for an algorithm is not applicable. The performance discussed relates to the device's physical and functional operation.

7. Type of Ground Truth Used:

For the performance data discussed (sterilization, biocompatibility, EMC, electrical safety, and design verification/validation), the "ground truth" is established through:

• Standardized testing procedures: Adherence to recognized national and international standards (e.g., ISO 11135, ISO 10993-1, IEC 60601-1-2, ES60601-1).
• Engineering specifications and design requirements: The device's performance is measured against predefined engineering and design specifications.
• Comparison to the predicate device: The performance is also judged in the context of being similar to the legally marketed predicate device.

8. Sample Size for the Training Set:

Not applicable, as this is not an AI/machine learning device that requires a training set.

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

Not applicable, as this is not an AI/machine learning device.

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