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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 Nasal/Oral Gastric Tube detailed in the K060555 and K070893 submission is of a single lumen design, with suction ports spanning the distal 15 inches of the tube, allowing ports to be positioned in the esophagus and stomach simultaneously. The only device modification presented in this Abbreviated 510(k) submission involves a tubing configuration modification for the Nasal/Oral Gastric Tube. The modified Nasal/Oral Gastric Tube is a dual lumen product with the addition of a vent lumen for the gastric section of the tube. While identical materials are used as compared to the Nasal/Oral Gastric Tube listed in submission K060555 and K070893, the dual lumen tubing allows one lumen to provide active suction while the second lumen provides passive venting in the gastric section.

The provided text is a 510(k) premarket notification for a medical device modification, specifically the CryoSpray Ablation™ System. This type of submission focuses on demonstrating "substantial equivalence" to a predicate device rather than presenting new clinical study data with acceptance criteria for device performance. Therefore, most of the requested information regarding acceptance criteria, study design, sample size, ground truth, and expert evaluation is not available in this document.

Here's an analysis of what can be extracted and what is missing:

1. Table of acceptance criteria and the reported device performance

• Not Available. This document describes a modification to an existing device (Nasal/Oral Gastric Tube) and relies on the substantial equivalence principle. It does not present performance data against specific acceptance criteria for the device itself, as would be expected for a new device requiring detailed clinical testing for efficacy or diagnostic performance. Instead, it states that the modified device "does not change the operating principals or mechanism of action" and is "substantially equivalent" to predicate devices.

2. Sample size used for the test set and the data provenance

• Not Available. No specific test set or associated sample size is mentioned. The submission is about a component modification and its substantial equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Available. As no test set data is presented, there's no mention of experts establishing ground truth.

4. Adjudication method for the test set

• Not Available. No test set data or adjudication is described.

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 ablation system, not an imaging or diagnostic AI device. Therefore, MRMC studies and AI assistance metrics are irrelevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This is a physical medical device, not an algorithm, so standalone algorithm performance is not relevant.

7. The type of ground truth used

• Not Available. No specific ground truth related to performance evaluation is mentioned in this document. The "ground truth" for substantial equivalence in this context is the performance and safety of the legally marketed predicate devices.

8. The sample size for the training set

• Not Applicable/Not Available. The concept of a "training set" for an algorithm does not apply to this physical device modification.

9. How the ground truth for the training set was established

• Not Applicable/Not Available. As above, this concept is not relevant to this submission.

Summary of Device Modification and Substantial Equivalence Claim:

The document describes a modification to the Nasal/Oral Gastric Tube component of the CryoSpray Ablation™ System.

• Original Tube: Single lumen design with suction ports.
• Modified Tube: Dual lumen design, adding a vent lumen for passive venting in the gastric section while one lumen provides active suction.
• Claim for Substantial Equivalence: The manufacturer asserts that the modification does not change the operating principles or mechanism of action of the system and that "identical materials are used". Therefore, the modified device is considered substantially equivalent to the previously cleared CryoSpray Ablation™ System (K070893 and K060555) and the CryMed Cryo-Ablator (K040809).

The FDA's decision to clear the device (K072651) indicates agreement with the manufacturer's claim of substantial equivalence based on the provided technical information, rather than new clinical performance data against specific acceptance criteria.

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