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It is a monopolar electrode intended for ablation and coagulation of soft tissues by means of electrical energy delivered by an electrical generator. It is used with compatible resectoscopes .

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This document is a 510(k) premarket notification letter from the FDA regarding "Modern Medical Resectoscope Electrodes." It confirms the device's substantial equivalence to legally marketed predicate devices.

The letter explicitly states that "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

This type of FDA letter (a 510(k) clearance) indicates that the device has been found substantially equivalent to a predicate device already on the market. A 510(k) clearance typically does NOT involve a comprehensive study with specific acceptance criteria and detailed performance data as would be required for a novel device or a PMA.

Therefore, based on the provided text, the document does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for training/testing.

The document primarily focuses on regulatory clearance based on substantial equivalence, rather than a detailed performance study report.

In summary, none of the requested information regarding acceptance criteria and a study proving device performance can be extracted from the provided text.

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