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The Luma-Cath™ Fixed Curve Electrophysiology Catheters are used for measurement of electrical activity in the heart.

The Irvine Biomedical, Inc. Luma-Cath™ Fixed Curve Electriophysiology Catheter System is a multiple-electrode electrophysiology recording catheter and its connecting cable. The diameter of the catheter is between 5 and 8 French. The diameter of the electrodes is between 5 and 8 French. There is a lumen with nominal internal diameter of 0.036 inch for insertion of a guidewire.

The provided text for the Luma-Cath™ Fixed Curve EP Catheters describes its intended use, design, and biocompatibility, but it does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.

The document is a summary of safety and effectiveness, and a 510(k) clearance letter from the FDA. These documents primarily focus on demonstrating substantial equivalence to a predicate device and confirming adherence to general safety and manufacturing standards, rather than detailing specific performance studies with quantitative acceptance criteria.

Therefore, I cannot provide the requested table of acceptance criteria and device performance, nor can I answer the questions related to sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details. These types of details are typically found in more extensive preclinical or clinical study reports, which are not included in the provided text.

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