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

The RithmID-SD Steerable Diagnostic Electrophysiology Catheter are biocompatible, flexible, radiopaque electrophysiology catheters that are available in a variety of diameters, lengths, curve shapes, and electrode number and spacing configurations, with a high-torque shaft with an array of platinum iridium alloy electrodes at the distal tip that can be used for recording electrical signals. The catheter is designed to facilitate the electrophysiological mapping of the heart.

The RithmID-SD Steerable Diagnostic Electrophysiology Catheter consist of a handle, a shaft and a steerable diagnostic tip. The catheter is introduced through the sheath and into the femoral vein, from the inferior vena cava into the heart and coronary sinus. The RithmID-SD Steerable Diagnostic Electrophysiology Catheter are available in 6F in various curves, including B, D, Y, and R curves.

The provided text is a 510(k) summary for a medical device called the "RithmID-SD Steerable Diagnostic Electrophysiology Catheter". This document focuses on demonstrating substantial equivalence to predicate devices, primarily through bench testing, biocompatibility testing, and comparisons of technical characteristics.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list acceptance criteria for each test in a separate column. Instead, for most tests, it states "All test samples met the acceptance criteria," indicating that the criteria were satisfied. The performance results are qualitative; for a few tests, comparative statements are made relative to the reference device.

Here's a compilation of the tests and their reported performance:

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