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The MedWaves AveCure™ Ablation System is intended for use in percutaneous, laparoscopic, and intraoperative coagulation-ablation of soft tissue.

The MedWaves AveCure™ Ablation System is not intended for use in cardiac procedures.

The MedWaves AveCure® Ablation System is designed to deliver ultrahigh radiofrequency (RF) through an antenna placed next to or embedded into soft-tissue for coagulating a volume of that tissue.

The MedWaves AveCure® Ablation System is composed of a durable generator-controller, and single-patient-use sterile accessories consisting of four antenna sizes and extension cable sets.

Each antenna-probe assembly is composed of one of the four antennas mounted at the distal end of one of many shaft configurations that are stiff, flexible or combination of both. The extension cable set is used to connect antennas to the generator controller. The material compositions of antennas and extension cables are nonmagnetic in nature and MRI safe. Therefore, the devices can be used in intraoperative, laparoscopic and percutaneous methods with CT, MR and Ultrasound imaging techniques to positions the antenna for ablation of softtissues.

The MedWaves AveCure® Ablation System is very efficient in transmitting RF power from the generator-controller to the antenna. With the low-power loss, the system does not need cooling pump, CO- or other mechanism to irrigate the antenna shaft and RF transmission lines for patient and user safety.

The provided document does not contain acceptance criteria for device performance based on a study, nor does it describe a study that proves the device meets specific performance criteria.

Instead, the document is a 510(k) summary for the MedWaves AveCure™ Ablation System, indicating that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. The "Performance Data" section primarily discusses compliance with design specifications, risk analysis, and medical device standards (electrical safety-EMC, biocompatibility, sterility, and packaging shelf-life). It makes a general statement about mechanical and coagulation-ablation performance:

"The mechanical and coagulation-ablation performance ex-vivo and in-vivo meets the intended design and shows to be similar to the predicated devices."

This statement does not provide specific acceptance criteria or detailed study results. Therefore, I cannot generate the requested table and information.

To answer your request, I would need a document that explicitly details:

• Specific, quantifiable acceptance criteria (e.g., minimum ablation zone diameter, maximum ablation time for a certain volume, specific temperature achieved).
• The methodology and results of a study designed to test these criteria.

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