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The Coronary Sinus Deflectable Mapping Catheter is indicated for electrophysiological mapping of cardiac structures; i.e., stimulation and recording only.

The Coronary Sinus Deflectable Mapping Catheter is a 10 pole deflectable mapping electrophysiology (EP) catheter with the ability to map electrical activity within the Coronary Sinus through distal Platinum/Iridium electrodes located along the catheter's pre-shaped tip. The pre-shaped tip MZ curve facilitates introduction of the catheter into the Coronary Sinus Ostium when approaching the Right Atrium through the inferior Vena Cava. This catheter includes a handle with a thumbknob, which allows deflection of the distal end of the catheter. The handle also has a 10 pin connector for interfacing to a recording system through a standard catheter cable. The catheter has a braided shaft and a distal tip that is unbraided to impart flexibility and softness, which enhances safety to the patient by reducing the chance of perforation. The catheter will be provided in 4, 5, 6 and 7 french sizes with either 2-5-2 or 2-8-2 electrode spacing.

The provided text focuses on a 510(k) summary for a medical device modification. It details the device, its intended use, and substantial equivalence to a predicate device, along with the testing performed. However, it does not contain information regarding a study with specific acceptance criteria and reported device performance metrics in the way you've outlined for AI/ML device studies.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as this information is not present in the provided document.

The document states:

• The modified device was assessed with "non-clinical bench tests to verify conformance with design and performance specifications."
• These tests included those "conducted to test performance and integrity after the device had been subjected to accelerated aging equivalent to 1 year of real-time aging."

This indicates that internal bench testing was performed to ensure the physical and functional aspects of the modified catheter met its design requirements, but it doesn't provide the detailed study design, acceptance criteria, or performance results typically found in clinical or AI/ML performance studies.

In summary, based only on the provided text, I cannot complete your request.

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