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The Amigo Remote Catheter System (Amigo) 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 CATHETERS OTHER THAN the Boston Scientific Blazer® Dx-20 and Biosense Webster EZ STEER" diagnostic catheters has not been established.

The Amigo Remote Catheter System (Amigo) 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 xray radiation field. The Amigo system includes several disposable components which help to maintain the sterile field.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Amigo Remote Catheter System:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, specific quantifiable acceptance criteria and device performance metrics are not detailed. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.

The "performance" described is in terms of meeting design specifications and customer requirements through various verification and validation tests:

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not applicable. No clinical test set (human patient data) was used. The testing was non-clinical (benchtop, in-vitro, etc.).
• Data Provenance: Not applicable. The data comes from internal non-clinical laboratory testing (e.g., electrical, mechanical, biocompatibility labs).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

• Number of Experts: Not applicable. Since no clinical test set was used, no experts were needed to establish ground truth for patient data. Expert judgment would have been involved in defining design specifications and interpreting non-clinical test results, but this is not a "ground truth" establishment in the typical sense for a clinical study.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No clinical test set requiring adjudication was used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done? No. The document explicitly states: "No additional clinical evaluations of the Amigo for the intended use were performed." This means no human reader studies, with or without AI assistance, were conducted.
• Effect Size: Not applicable.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

• Was standalone performance done? Yes, in a non-clinical context. The "standalone performance" refers to the device itself (the Amigo system) performing its intended functions without human intervention acting as a variable in the performance metric. The non-clinical tests (electrical/mechanical safety, functional performance, cleaning, biocompatibility, sterilization, shelf life, transit studies) assess the device's inherent performance against specifications. However, this is not an "algorithm" in the typical sense of AI/ML.

7. Type of Ground Truth Used

• Type of Ground Truth: For the non-clinical tests, the "ground truth" was established by engineering design specifications, industry standards (ISO 14971, IEC 60601-1, IEC 60601-1-2, ISO 10993-1), and customer requirements. The device's performance was compared against these pre-defined benchmarks.

8. Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device is a mechanical/electrical catheter control system, not an AI/ML algorithm that requires a training set. The "design verification and validation testing" serves as the assessment of the final product, not a "training set" in the machine learning context.

9. How the Ground Truth for the Training Set Was Established

• How Ground Truth for Training Set Was Established: Not applicable. No training set was used.

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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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