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The NEUWAVE™ Microwave Ablation System and Accessories are indicated for the ablation (coagulation) of soft tissue in percutaneous, open surgical and in conjunction with laparoscopic surgical settings, including the partial or complete ablation of non-resectable liver tumors.

The NEUWAVE Microwave Ablation System is not indicated for use in cardiac procedures.

The NEUWAVE Microwave Ablation System is a self-contained stand-alone system of hardware and software designed for the ablation of soft tissue, including the partial or complete ablation of non-resectable liver tumors, which applies microwave energy to produce tissue heating effects generating tissue necrosis.

The system consists of three major components (1) a cart which contains the components necessary to deliver microwave power to the microwave ablation probes, monitor and control system functions, a graphical user interface for the user to interact with the system and a CO2 based cooling system, (2) a Power Distribution Module (PDM), (3) a range of microwave ablation probe accessories for energy delivery.

The provided text describes modifications to an existing microwave ablation system and does not contain information about an AI/ML powered device. Therefore, I cannot extract the acceptance criteria and study details as per your request, as the input document does not pertain to AI/ML device performance.

The document focuses on the NeuWave Microwave Ablation System and its accessories, specifically detailing changes and comparisons to predicate devices for a 510(k) submission. This is a medical device approval process based on substantial equivalence, not AI/ML performance metrics.

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