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The MAGiC Sweep™ EP Mapping Catheter is intended for intracardiac electrophysiological recording and/or stimulation for pacing in the heart.

The MAGiC Sweep™ EP Mapping Catheters are biocompatible, flexible, radiopaque fixed catheters that are 130cm in length and available in multiple electrode spacing configurations and multiple magnet spacings. They have magnets encapsulated in the device shaft to allow manipulation through the vasculature and placement by a physician controlled robotic magnetic navigation system. Each device consists of 19 electrodes plus one tip electrode and come in three (3) different electrode spacings. In addition there are twenty (20) different magnet spacings for each electrode spacing configuration. The catheters are 8F diameter tapering to 5F at the distal end of the device shaft. The variety of configurations facilitate the navigation of the device to specific areas of the heart and facilitate recording of intracardiac signals and/or stimulation in the atrial and ventricular regions of the heart during electrophysiology studies.

The MAGiC Sweep™ EP Mapping Catheter is designed to be positioned in various endocardial and intravascular sites utilizing the Stereotaxis magnetic navigation system (MNS) along with the Stereotaxis catheter advancement system (CAS). The MAGiC Sweep™ EP Mapping Catheter is designed for recording intracardiac signals when connected to a recording system and for cardiac stimulation when connected to a stimulation system.

The MAGiC Sweep™ EP Mapping Catheter is comprised of a Pebax catheter shaft, platinum-iridium ring electrodes, platinum-iridium electrode tip, Neodymium Boron Magnets attached to a safety cable, and Redel electrical connectors. The Neodymium Boron Magnets are encapsulated within the catheter shaft.

The provided 510(k) clearance letter and summary describe the acceptance criteria and the study that proves the device meets the acceptance criteria for the Stereotaxis MAGiC Sweep™ EP Mapping Catheter.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document details two primary types of testing: Bench Testing and Animal Testing.

• Bench Testing: The sample size for each specific bench test (visual, dimensional, electrical, mechanical, biocompatibility, packaging) is not explicitly stated in the provided text. It is generally understood that such testing involves a sufficient number of samples to ensure statistical validity, but the exact numbers are not given.
• Animal Testing: The sample size for animal testing is not explicitly stated. It mentions "an animal studies (porcine model)," indicating that some number of porcine subjects were used, but the specific count is not provided.
• Data Provenance:
  • Bench Testing: This is laboratory-based testing, so the data provenance is derived from the manufacturer's internal testing facilities.
  • Animal Testing: The animal study was conducted using a porcine model. The country of origin for the animal study data is not specified. The study was prospective as it involved actively using the device in live subjects to assess its performance.

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

The document does not specify the number of experts used or their qualifications for establishing ground truth, particularly for the animal study. The animal study reports that the catheter was "advanced, positioned and successfully mapped" by presumably a researcher or veterinary expert, but no details on their number or credentials are provided. For bench testing, the "ground truth" is typically established by engineering specifications and standards, not by human experts interpreting results.

4. Adjudication Method for the Test Set

The document does not mention any specific adjudication method (e.g., 2+1, 3+1) for the test set. For bench and animal testing, adjudication usually means verifying that the device performance meets pre-defined engineering and biological specifications rather than a consensus among human reviewers.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed, nor is it applicable to this device. This device is an EP mapping catheter, a hardware medical device used for recording and stimulation, not an AI/software device that assists human readers in interpreting medical images or data. Therefore, there is no mention of human readers improving with or without AI assistance, or an effect size.

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

Since this is a hardware device (EP mapping catheter) and not a software/AI algorithm, the concept of "standalone performance" in the context of an algorithm without human-in-the-loop performance is not applicable. Its performance is inherently linked to its physical interaction for recording and stimulation, guided by a physician using a robotic system.

7. Type of Ground Truth Used

• Bench Testing: The ground truth for bench testing was established by adherence to existing standards and test methods. This means the performance metrics (e.g., electrical continuity, tensile strength, biocompatibility profiles) were compared against pre-defined engineering specifications and regulatory limits.
• Animal Testing: The ground truth for animal testing was established by observational functional performance during live animal studies. This involved observing whether the catheter could be successfully advanced, positioned, and used to map the defined heart chambers. This can be considered a form of "outcomes data" in a controlled experimental setting.

8. Sample Size for the Training Set

The document does not mention a training set. This is expected because the MAGiC Sweep™ EP Mapping Catheter is a physical medical device (hardware), not an artificial intelligence (AI) or machine learning (ML) algorithm that requires a training set. The development and testing of this device involve engineering design, material selection, and rigorous physical and biological testing, not data-driven model training.

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

As there is no training set for this hardware device, the concept of establishing ground truth for a training set is not applicable.

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