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Arox bipolar, passive-fixation, endocardial pacing leads (Arox xx-BP and Arox xx-JBP) are intended to provide permanent pacing and sensing in the atrium and or ventricle when used with a compatible pulse generator.

The BIOTRONIK Arox lead is a bipolar, passive-fixation, endocardial pacing lead available in straight and " J"-shaped configurations, for placement in the ventricle or atrium. The designation Arox xx-BP refers to Arox straight leads, which are available in lengths (xx) of 53 or 60 cm; Arox xx-JBP refers to Arox "J"-shaped leads, which are available in lengths of 45 and 53 cm.

The Arox xx-JBP model has a permanent bend proximal to both lead electrodes, resulting in the distal portion of the lead body having what is commonly referred to as a "U" or "J" shape. This lead shape facilitates placement in the right atrial appendage.

Arox xx-BP and Arox xx-JBP leads feature four silicone tines for passive-fixation in the heat's trabeculae. The tip electrode is made of a platinum/iridium base material, with a fractal iridium surface and electrically active surface area of 3.5 mm². The ring electrode is made of a platinum/iridium base material, with a fractal iridium surface and electrically active surface area of 22.6 mm². The lead conductor consists of quadrifilar MP35N wire in a coaxial configuration, insulated with silicone rubber tubing. All Arox leads utilize a 3.2 mm IS-1 connector.

The provided text is a 510(k) summary for the BIOTRONIK Arox Passive-Fixation, Bipolar, Endocardial Pacing Lead. This document describes the device, its intended use, and its substantial equivalence to previously cleared predicate devices. It does not contain information about acceptance criteria, study methodologies, sample sizes, ground truth establishment, or expert involvement for a study proving device performance against acceptance criteria.

The 510(k) process is primarily a premarket notification for demonstrating substantial equivalence to a legally marketed predicate device, not necessarily a comprehensive clinical study to prove performance against specific acceptance criteria in the way a clinical trial would. Therefore, I cannot extract the requested information from this document.

The document mainly focuses on:

• Device Description: Physical characteristics, materials, and configurations.
• Device Modification: Differences from a previously marketed device (Merox leads) and similarities to another (Polyrox leads).
• Predicate Devices: Identification of existing devices to which the Arox leads are compared for substantial equivalence.
• Indications for Use: The medical conditions and manner in which the device is intended to be used.

To answer your questions, one would typically need access to the full 510(k) submission, including any testing reports, bench test results, or, if applicable, clinical study summaries, which are not provided in this specific excerpt.

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