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Reusable dispersive electrode to collect and return electro-surgical current form the patient produced at the oloolis cargical during electrosurgical procedures back to the generator and earth ground.

Reusable Electrosurgical Dispersive Electrode

This document is a 510(k) clearance letter from the FDA for a medical device called the "ConMED Reusable Dispersive Electrode." It is not a study or a report that describes acceptance criteria and device performance.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer the questions about sample sizes, expert ground truth, adjudication methods, or MRMC studies. This information would typically be found in a clinical study report or a pre-market approval application, not in a 510(k) clearance letter.

The 510(k) process is primarily a demonstration of "substantial equivalence" to a legally marketed predicate device, rather than a full clinical study proving efficacy and safety against specific acceptance criteria.

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