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The Catheter is intended for use in electrogram recording and cardiac stimulation during diagnostic electrophysiology study.

6-French 20-Electrode Electrophysiology Diagnostic Catheter

The provided text is a 510(k) clearance letter from the FDA for a medical device. This document does not contain the information requested about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth methods.

The letter simply states that the FDA has reviewed the 510(k) notification for the "6-French 20-Electrode Electrophysiology Diagnostic Catheter" and determined it to be substantially equivalent to legally marketed predicate devices for its intended use (electrogram recording and cardiac stimulation during diagnostic electrophysiology study).

To answer your questions, I would need access to the actual 510(k) submission document, which would include the performance testing data and clinical study reports.

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