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The Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheter can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.

The Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheter is a flexible electrode catheter constructed of a polyurethane insulation/shaft and incorporates platinum electrodes. The active tip may be manipulated by remote means located at the proximal end of the catheter.

The provided document is a 510(k) premarket notification letter and summary for a Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheter. This document describes the device's technical characteristics, predicate devices, and the testing performed to demonstrate its safety and effectiveness.

Crucially, this document pertains to a medical device that is reprocessed (reused after cleaning and sterilization), not an AI/ML-enabled medical device. Therefore, the information requested in your prompt regarding acceptance criteria, study methodologies (e.g., MRMC studies, standalone AI performance), ground truth establishment, expert adjudication, and sample sizes for AI training/test sets is not applicable to this specific document.

The document focuses on demonstrating substantial equivalence to a predicate device through:

• Technological Characteristics: Stating that the reprocessed device has identical purpose, design, materials, function, and intended use as the predicate devices, with no changes to claims, clinical applications, patient population, performance specifications, or method of operation.
• Functional and Safety Testing: A list of bench and laboratory tests performed, including biocompatibility, cleaning validation, sterilization validation, functional testing (visual inspection, dimensional verification, electrical continuity and resistance, simulated use, mechanical characteristics), electrical safety testing (dielectric and current leakage), and packaging validation.

Since this is not an AI/ML device, I cannot fill in the requested table and study information as it's designed for AI/ML performance evaluation. The "acceptance criteria" for this device would be its ability to meet the performance and safety standards of the predicate device after reprocessing, as demonstrated by the functional and safety testing listed.

In summary, based on the provided text, I cannot describe acceptance criteria and study proving device meets acceptance criteria related to AI/ML performance, because the document is about a reprocessed medical catheter, not an AI/ML device.

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