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The SprayGenix™ Cryo 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 SprayGenix™ Cryo Ablation System is a cryosurgical device. consisting of an electronic console, cryo-catheter, nasal/oral gastric tube and cryogen delivery system. The SprayGenix™ Cryo 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 cryo-catheter to perform the cryo-ablation procedure. The catheter 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. Cryosurgical procedures are used when surgical resection is not indicated, and may also provide an alternative to typical resection in certain cases.

The provided text is a 510(k) safety summary for the SprayGenix™ Cryo Ablation System. It focuses on demonstrating substantial equivalence to predicate devices and does NOT contain information about specific acceptance criteria or a study proving the device meets them.

Therefore, I cannot fulfill your request as the necessary information is not present in the provided document. The document describes the device, its intended use, and lists predicate devices, but lacks details about performance metrics, study designs, sample sizes, ground truth establishment, or expert involvement for evaluating specific acceptance criteria.

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