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For the simultaneous cutting and cauterization of soft tissue during surgery.

The Starion Instruments Thermal Cautery Probe is a single use, handheld surgical instrument intended for simultaneous cutting and cauterization of soft tissue during surgery. The Starion Instruments Thermal Cautery Probe allows the surgeon to position the probe in the region of tissue to be cauterized. The Thermal Cautery Probe features a handle, a finger/footswitch control and power cord for connection to a Starion Instruments power supply.

The provided text is a 510(k) summary for the Starion Instruments Thermal Cautery Probe, which describes its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance results, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

Therefore, I cannot provide the requested table and details because the information is not present in the given document.

The document primarily focuses on the regulatory submission process and the FDA's determination of substantial equivalence based on the device's intended use, target population, energy source, and principles of operation being similar to the predicate device. It does not include a technical performance study with quantitative results against specific acceptance criteria.

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