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The Amigo Remote Catheter System (RCS) is intended to facilitate manipulation, positioning and control of percutaneous diagnostic catheters for stimulating cardiac tissue and for recording electrophysiological data in the right atrium and right ventricle.

The safety and effectiveness of this device for ablation in the treatment of cardiac arrhythmias including atrial fibrillation, has not been established.

The safety and effectiveness of this device for cardiac mapping when used with any catheter other than the Boston Scientific Blazer™ Dx-20 has not been established.

The Amigo RCS is designed to create a simple interface with commercially available catheters allowing the physician to insert, withdraw and rotate the catheter, and deflect the catheter tip via the remote controller. Catheter placement and positioning is performed under direct visualization using standard imaging equipment, while enabling the physician to remain seated and away from the x-ray radiation field. The Amigo RCS system includes several disposable components which help to maintain the sterile field.

The provided text describes the Amigo Remote Catheter System (RCS) and its 510(k) clearance (K113628) but does not contain a table of acceptance criteria or a detailed study description with specific performance metrics against those criteria.

Instead, it states that:

• Design verification and validation testing was performed to ensure the device met design specifications and customer requirements.
• Testing activities included: electrical/mechanical safety tests, functional performance tests, cleaning, biocompatibility, sterilization, shelf life, and transit studies.
• Risk analysis activities were completed based on ISO 14971.
• Electrical/mechanical device safety and electromagnetic compatibility testing were conducted in accordance with IEC 60601-1 and 60601-1-2, respectively.
• Biocompatibility studies were performed in accordance with ISO 10993-1.
• A clinical evaluation was performed and "confirmed that Amigo RCS is safe and effective and operates as designed for its intended use and as described in its proposed labeling."

Without access to the actual verification and validation reports or the clinical study report, it's impossible to extract the specific acceptance criteria and detailed reported device performance in a tabular format as requested. The document only provides general statements about testing and compliance with standards.

Therefore, I cannot fulfill your request for item 1, 2, 3, 4, 5, 6, 7, 8, and 9 as the detailed information on the study, including specific performance metrics, sample sizes, ground truth establishment, and expert involvement, is not present in the provided 510(k) summary. The summary focuses on demonstrating substantial equivalence to predicate devices and general compliance with regulatory standards.

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