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The EnSite Array Multi-Electrode Diagnostic Catheter, when used with the EnSite System, is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone (i.e. linear mapping catheters).

The EnSite Array Multi-electrode Diagnostic Catheter (EnSite Array Catheter) is a single use, 9 French, percutaneous catheter. The EnSite Array Catheter is designed for use only with the EnSite System and for deployment in the right atrium. The proximal end contains the patient cable electrical connector, an inflation port for the distal balloon/braid multi-electrode array (MEA), luer port compatible with a 0.035" guidewire, and a push shaft to facilitate expansion and deployment of the MEA. The shaft is a coaxial design with a polyurethane outer sheath. At the distal end in addition to the MEA, there are three ring electrodes; one distal and two proximal mounted at specific locations to the MEA. The tip of the catheter is a pigtail shape to minimize trauma to the endocardium.

The EnSite Array Catheter does not require direct contact with the endocardium for the detection of intracardiac electrograms. The EnSite System connected to the EnSite Array Catheter utilizes proprietary software algorithms to reconstruct and display right atrial endocardiograms detected by the EnSite Array Catheters' MEA.

The provided text is a 510(k) Summary for the St. Jude Medical EnSite Array Multi-Electrode Diagnostic Catheter. It describes the device, its intended use, and comparison to a predicate device. However, it explicitly states that no clinical testing was submitted, referenced, or relied upon for the determination of substantial equivalence. The evaluation was based on non-clinical testing to verify device modifications and biocompatibility.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not available in the provided document. The device's substantial equivalence was determined based on non-clinical aspects and comparison to a predicate device (K983456).

Here's a breakdown of what can be extracted, and what is missing based on the prompt's requirements:

1. Table of Acceptance Criteria and Reported Device Performance:

• Missing. The document states "An evaluation of the modified EnSite Array Multi-Electrode Diagnostic Catheter was performed to verify the device modifications. It was concluded that the modified EnSite Array Multi-Electrode Diagnostic Catheter design meets the product specification and intended use." However, specific acceptance criteria and performance metrics are not detailed.

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

• Missing. No clinical test set was used.

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

• Missing. Not applicable as no clinical test set was used.

4. Adjudication Method for the Test Set:

• Missing. Not applicable as no clinical test set was used.

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

• Missing. No clinical testing, including MRMC studies, was performed or submitted.

6. Standalone (Algorithm only) Performance Study:

• Missing. The device is a physical catheter, not a standalone algorithm. While it works with an "EnSite System" that "utilizes proprietary software algorithms," the data provided focuses on the catheter's equivalence based on non-clinical aspects. No performance study for such algorithms is detailed.

7. Type of Ground Truth Used:

• Missing. Not applicable as no clinical data or ground truth for the device's diagnostic performance was established for this submission. The "ground truth" for the submission was that the device met its product specifications and intended use via non-clinical verification and biocompatibility testing.

8. Sample Size for the Training Set:

• Missing. Not applicable as no machine learning algorithm training set is mentioned for this submission.

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

• Missing. Not applicable as no training set is mentioned.

Summary of Non-Clinical Testing (from the provided text):

• Non-Clinical Testing Performed: Evaluation of modified EnSite Array Multi-Electrode Diagnostic Catheter to verify device modifications. Biocompatibility testing in accordance with ISO 10993-1.
• Conclusion: The modified design meets product specification and intended use. Biocompatibility was confirmed.
• Basis for Equivalence: Same intended use and fundamental scientific technology as the predicate device (EnSite Array Multi-Electrode Diagnostic Catheter, K983456). All technological characteristics (packaging, biocompatibility, sterilization, labeling) are substantially equivalent. Design modifications do not adversely affect safety and effectiveness.

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