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

The CryoSpray Ablation™ System is used to destroy unwanted tissue by application of extreme cold to a selected site. Liquid Nitrogen is stored in a tank and then propelled through a cryocatheter to perform the cryo-ablation procedure. The catheter, an accessory component of the CSA System, is placed in the appropriate position through the use of visual observation. The cryo-catheter applies the cryogen to a selected area and freezes the unwanted tissue. The catheter detailed in the K060555 submission is of a single lumen, straight tip design.

This document is a Special 510(k) submission for a modification to the CryoSpray Ablation™ System, specifically a directional spray catheter. The submission focuses on demonstrating substantial equivalence to a previously cleared device (K060555) rather than providing detailed performance studies with acceptance criteria.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, including sample sizes, ground truth establishment, expert qualifications, and MRMC studies, is not present in the provided text. The document is a regulatory submission for a device modification, and as such, relies on comparisons to the predicate device and established technical characteristics rather than new performance studies with specific statistical acceptance criteria.

Here's a breakdown of why each specific point cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance: Not provided. The submission states the modification "does not change the operating principals or mechanism of action" and that the "surface area of the radial hole... is similar to the hole in the lumen opening of the straight spraying catheter." This implies equivalence in performance rather than new, independently measured performance against specific criteria.

2. Sample sized used for the test set and the data provenance: No test set is described. The submission focuses on the design change of the catheter tip.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no test set requiring ground truth establishment is described.

4. Adjudication method for the test set: Not applicable.

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: Not applicable. This device is a cryosurgical tool, not an AI-assisted diagnostic or interpretive system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used: Not applicable.

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable.

Summary of available relevant information from the document:

• Device Modification: The only modification is a tip configuration change in the cryocatheter. The end of the cryo-catheter is closed, and a side hole is located in the distal side, allowing a radial spray of the cryogen.
• Materials: Identical materials are used as compared to the predicate catheter (K060555).
• Dimensions: All other dimensional specifications are identical to the predicate catheter.
• Surface Area: The surface area of the radial hole of the new catheter is similar to the hole in the lumen opening of the straight spraying catheter.
• Operating Principles: The modification "does not change the operating principals or mechanism of action" for the CryoSpray Ablation System.
• Intended Use: The intended use has not changed.
• Basis for Equivalence: Based on principles of operation, design, materials, and intended use, the modified catheter is considered substantially equivalent to devices currently marketed.

The document demonstrates substantial equivalence by focusing on the lack of significant change in the device's fundamental characteristics and intended use, rather than presenting a performance study with defined acceptance criteria.

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