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The Tri-Loop™ Microwave Ablation Probe is intended for coagulation of soft tissue. Not for use in cardiac procedures.

The device consists of 3 pre-shaped curved microwave antennas which is contained within 3 delivery cannulas. The cannulas are attached to a handle mechanism that deploys the antennas into the targeted tissue. RF energy can be used to facilitate deployment of the antennas into tissue. The Vivant VivaWave™ Microwave Generator (K011676) is used to deliver the microwave energy to the curved antennas which heats the tissue within and around the antennas.

The provided text is a 510(k) summary for the Tri-Loop™ Microwave Ablation Probe. It states the device's intended use and claims substantial equivalence to a predicate device. However, it does not contain any studies, acceptance criteria, or performance data to directly answer your specific questions about device performance and study methodology.

The supplied document is a regulatory submission for premarket clearance, which focuses on demonstrating equivalence to an already legally marketed device (predicate device). Such submissions typically do not include detailed performance studies with acceptance criteria in the way you've described for AI/diagnostic devices.

Therefore, I cannot populate the table or answer the subsequent questions based on the provided input. The document explicitly states:

• "Summary of Substantial Equivalence: The Tri-Loop™ Microwave Ablation Probe is equivalent to the predicate products. The indications for use, basic overall function, methods of manufacturing, and materials used are substantially equivalent."

This indicates that the clearance was based on equivalence, not on independent performance studies against defined acceptance criteria for a novel functionality.

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