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The RadioTherapeutics Corp. RF Generator is a medium power electrosurgical generator intended for use with separately approved electrodes for the thermal coagulation of soft tissues.

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I am sorry, but based on the provided text, I cannot provide the detailed information you requested about acceptance criteria and the study that proves the device meets them.

The document is a 510(k) clearance letter from the FDA for the RadioTherapeutics RF Generator Model #RF-2000. It states that the device has been reviewed and determined to be "substantially equivalent" to predicate devices marketed prior to May 28, 1976. This letter primarily focuses on the regulatory clearance and indications for use, rather than detailed performance study results or acceptance criteria.

The text does not contain:

• A table of acceptance criteria and reported device performance.
• Information about sample sizes for test or training sets.
• Data provenance, number of experts, qualifications, or adjudication methods.
• Details about MRMC comparative effectiveness studies or standalone algorithm performance.
• The type of ground truth used or how it was established.

This document is a regulatory approval, not a scientific study report describing the device's performance in detail against specific criteria.

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