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The Reflexion Spiral™ catheter can be used for recording intracardiac signals and for cardiac stimulation during electrophysiology studies. The Reflexion Spiral™ catheter is to be used to map the atrial regions of the heart.

The St. Jude Medical (SJM) Reflexion Spiral™ Variable Radius Catheter (Reflexion Spiral catheter) is a flexible, asymmetric, bi-directional, radiopaque variable radius loop electrophysiology catheter constructed of a polymer shaft that incorporates platinum electrodes.

The Reflexion Spiral catheter has a proximal handle (ComfortGrip™) that contains: 1) A shaft actuator mechanism for varying the asymmetrical sweep (90° sweep) and curl (180° curl) of the distal portion of the shaft. 2) A loop actuator mechanism for varying the loop diameter from approximately 25mm to approximately 15mm. 3) An electrical connector fitted into the proximal end of the handle.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state specific acceptance criteria in terms of numerical performance targets. Instead, it relies on demonstrating equivalence to a predicate device. The performance is described in a comparative manner rather than against pre-defined numerical thresholds.

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

• Sample Size for Test Set: The document does not specify a patient or clinical sample size for the test set. The testing described is primarily non-clinical (bench and animal data).
• Data Provenance: The data comes from bench testing and animal studies conducted by St. Jude Medical. No information on country of origin of data or whether it was retrospective or prospective is provided for the non-clinical tests.

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

• Number of Experts: This information is not provided in the document.
• Qualifications of Experts: This information is not provided in the document.

Given that the studies were primarily non-clinical (bench and animal), "ground truth" would likely refer to engineering specifications or physiological measurements in the animal model, rather than expert interpretation of clinical data.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:

• Adjudication Method: Not applicable/Not mentioned. Since the studies were non-clinical (bench and animal) and no expert review of clinical cases is described, there would be no need for a human adjudication method for establishing ground truth as would be relevant in a clinical imaging or diagnostic study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The device in question is a physical medical catheter, not an AI-assisted diagnostic tool for human readers. Therefore, the concept of human readers improving with AI assistance is not relevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Standalone Performance: Not applicable/Not done in the context of an algorithm. The device is a physical catheter, not an algorithm. The "standalone performance" was demonstrated through bench testing and animal data to show its functional capabilities and safety, independent of human interpretive assistance (as it's a tool for direct physiological measurement/stimulation).

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

• Ground Truth Type: For the non-clinical tests, the "ground truth" would be established by:
  • Engineering Specifications: For bench testing of loop radius control, sweep/curl positioning, and electrical characteristics.
  • Physiological Measurements/Observation: In animal studies, to ensure the catheter can record intracardiac signals and provide cardiac stimulation as intended, and to assess biocompatibility and safety.
  • Compliance with Standards: Meeting the requirements outlined in FDA Guidance and ISO 10555-1.

8. The Sample Size for the Training Set:

• Sample Size for Training Set: Not applicable. As this is a physical medical device and not an AI/machine learning model, there is no "training set."

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

• Ground Truth for Training Set Establishment: Not applicable. There is no training set for this device.

Summary of Study and Device Performance:

The study described for the Reflexion Spiral™ Variable Radius Catheter is a non-clinical study primarily consisting of:

• Bench Testing: To evaluate functional performance aspects like loop radius control and sweep/curl positioning, comparing them to the predicate device.
• Animal Data: Likely to assess in-vivo performance, safety, and biocompatibility.

The purpose of these studies was to demonstrate substantial equivalence to a currently marketed predicate device (Irvine Biomedical, Inc., (IBI) Inquiry™ Optima™ Steerable Electrophysiology Catheter K042775) and conformance to relevant industry standards (FDA Guidance and ISO 10555-1). The document asserts that the device achieves functional equivalence to the predicate and does not introduce new safety or effectiveness concerns, thereby meeting the requirements for 510(k) clearance by the FDA.

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