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The device will be generally placed in the high right atrium, right ventricular apex, and His bundle, and in the coronary sinus of the cardiac anatomy, and be used for electrogram recording and cardiac stimulation during diagnostic electrophysiology study.

Slim Cath-Dx™ Cardiac Electrophysiology Diagnostic Catheter

I apologize, but the provided text from the FDA 510(k) clearance letter for the Slim Cath-Dx™ Cardiac Electrophysiology Diagnostic Catheter does not contain any information regarding acceptance criteria or a study proving the device meets those criteria.

This document is a clearance letter, which states that the FDA has reviewed the 510(k) submission and determined the device is substantially equivalent to a legally marketed predicate device for its stated indications for use. It outlines regulatory class, product codes, and general controls, but it does not detail the specific performance metrics, clinical study design, or results that demonstrate the device's efficacy or safety against pre-defined acceptance criteria.

Therefore, I cannot provide the requested table or answer the specific questions about the study design, sample sizes, ground truth establishment, or expert involvement based on the information given.

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