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The IBI Luma-Cath™ Steerable Electrophysiology Catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies. The catheters are commonly placed in the high right atrium, right ventricular apex, and the His bundle.

The Irvine Biomedical, Inc. Luma-Cath™ Steerable Electrophysiology Catheter System is a multiple-electrode electrophysiology recording catheter and its connecting cable. The diameter of the catheter is between 6 and 8 French. The diameter of the electrodes is between 6 and 8 French. There is a lumen with nominal internal diameter of 0.036 inch.

The provided text does not contain information regarding detailed acceptance criteria, a specific study proving device performance against those criteria, or the methodology typically associated with such studies (like sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies).

The text is a summary of safety and effectiveness for a 510(k) submission, confirming the device's substantial equivalence to predicate devices and its compliance with general controls. It focuses on biocompatibility, performance tests (without detailing them or their outcomes), manufacturing quality, and regulatory approval.

Therefore, I cannot fulfill your request for the specific points listed (Table of acceptance criteria, sample sizes, expert qualifications, ground truth, MRMC study, standalone performance, training set details) because this information is not present in the provided document.

The document indicates:

• Device: Luma-Cath™ Steerable Electrophysiology Catheter System
• Purpose: Electrophysiology recording and cardiac stimulation during diagnostic electrophysiologic studies.
• Safety and Effectiveness Claim: Based on biocompatibility, passed unnamed performance tests, manufacturing process following GMP, and substantial equivalence to predicate devices.
• Predicate Device: K961924 for accessory cables (though this is for the cables, not the catheter itself, which is stated to have patient contact materials "the same as the predicate devices").
• Regulatory Conclusion: Device is "substantially equivalent" to legally marketed predicate devices.

Without specific performance metrics and a study design, I cannot populate the requested table or answer the detailed questions about the study's execution.

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