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The Niobe System is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart and coronary vascular and peripheral vasculature by orienting the device tip in a desired direction.

The Cardiodrive Catheter Advancement System (CAS) is intended to automatically advance and retract compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis MNS.

The Cardiodrive system is not intended to advance the EP mapping and ablation catheters through the coronary vasculature or the coronary sinus.

The Cardiodrive system is not intended to advance or retract non-compatible catheters and/or other non-compatible devices into the neurovasculature.

The Stereotaxis Niobe Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodrive (a.k.a. the Niobe System) is an interventional workstation for the intravascular navigation of appropriately equipped, magnetically adapted, devices (e.g., catheters or guidewires) through tissue to designated target sites. The Niobe System uses computer-controlled permanent magnets for orientating the tip of a magnetic device and employs magnetic fields only to orient or steer the tip of a magnetic device and remotely advance and retract only compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart. The Niobe System incorporates software that determines the direction the magnetic field should be applied based on physician interaction with the user interface devices.

The provided text describes the acceptance criteria and the studies that demonstrate the Stereotaxis Niobe® Magnetic Navigation System (MNS) with Navigant™ Workstation (NWS) and Cardiodrive® meets these criteria. The information is extracted from a 510(k) premarket notification.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from the "Special Controls" section, and the reported performance is from "How Special Control Has Been Met."

• "Overwhelming evidence" from four submitted studies (3.9% major adverse event rate, 95.0% acute success, 96.5% 90-day success).
• More than 8,000 patients reported in literature using MNS with a major complication rate of 0.72% (compared to manual rate of 2.1%).
• Acute and long-term success rates were similar in MNS and manual groups in literature.
  Stereotaxis proposes continued monitoring through literature and Post Marketing Surveillance program. |
  | 5. Training program for clinical and supporting staff | Representatives from the company train physicians and staff. The Niobe ES User's Manual provides operating instructions. Information is reviewed during simulation sessions and phantom training with the actual system. |
  | 6. Performance data for sterility of sterile disposable components | The Niobe System is not sterile and not required to be sterilized. The Cardiodrive includes a single-use disposable (QuikCAS) (sterile component). Sterilization testing for QuikCAS resulted in a PASS. |
  | 7. Performance data for shelf life (sterility, package integrity, functionality) | The Niobe System is not sterile and thus shelf life for system components is not applicable. The Cardiodrive includes a single-use disposable (QuikCAS) (sterile component). Shelf-life/packaging and sterilization testing for QuikCAS resulted in a PASS, and each component was validated for a shelf life of 3 years. |
  | 8. Labeling requirements (Instructions, warnings, cautions, limitations, training, compatibility, testing summaries, technical parameters, expiration) | The Niobe ES User's Manual includes compatible catheters, indications for use, warnings, and safety controls. It has instructions for procedure room components, system positions, table-side magnet controller, power up, cover force sensor, navigation position assistance, software info, Cardiodrive CAS user interface, and activation codes. It explicitly states the Niobe System doesn't have reusable components requiring reprocessing/disinfection. Cleaning instructions for magnet pods are provided. A list of compatible catheters (Biosense Webster Navistar RMT, Navistar RMT Thermocool, Celsius RMT, Celsius RMT Thermocool; Stereotaxis Helios II) and mechanical performance testing is included. Summaries of in vivo testing, adverse events, procedure-related complications, study outcomes, and endpoints are summarized. Fluoroscopy times are reported. Relevant warnings based on complaints and clinical studies have been included. The system generates a directional 0.08T or 0.1T magnetic field within a 6-inch diameter navigation volume. Not applicable for system expiration date/shelf life; for QuikCAS, it is 3 years. |

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

• Test Set (Clinical Data):
  • Sample Size: A total of 511 patients across 4 clinical studies (ATTRAC, ATTRAC II, HEART Study, VERSATILE).
  • Data Provenance: The data comes from Stereotaxis-sponsored clinical studies that were previously submitted to the FDA for other regulatory approvals (P050029, K071029, K140804). The location of these studies (e.g., country of origin) is not explicitly stated in the provided text.
  • Retrospective/Prospective: All four studies were prospective in nature.

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

• The document does not specify the number of experts used to establish ground truth for the clinical outcomes (e.g., major complications, acute success, 90-day success).
• However, it does mention that:
  • For the VERSATILE study, the DSM (Data Safety Monitoring) adjudicated these events (referring to cardiac tamponade events). This implies expert review of adverse events, but the number and qualifications of DSM members are not provided.
  • Physician feedback forms were used for "User assessment of device remote controls and safety features," suggesting clinical expert input on device usability.

4. Adjudication Method for the Test Set

• For adverse events in the VERSATILE study, the DSM (Data Safety Monitoring) was involved in adjudication. The specific method (e.g., 2+1, 3+1) is not detailed.
• For other clinical endpoints like acute and 90-day success, the adjudication method is not described in detail, though it would typically involve clinical follow-up and determination by clinicians/investigators within the study protocols.

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

• The provided text describes a medical device (a robotic catheter navigation system), not an AI-powered diagnostic or interpretive tool. Therefore, the concept of a "multi-reader multi-case (MRMC) comparative effectiveness study" focusing on human readers improving with AI assistance is not applicable here. The device assists the physician in physically performing a procedure.
• The document does mention a comparison to "manual rates" for major complications and similar success rates in the literature between the MNS and manual groups, indicating some level of comparative safety and efficacy analysis against conventional methods. However, this is not an MRMC study comparing human reader performance with and without AI assistance for interpretation.

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

• This question is not applicable to this device. The Niobe System is an interventional workstation designed to be operated with a human-in-the-loop (a physician) to navigate catheters. It is not an algorithm performing a task independently.

7. The Type of Ground Truth Used

• Clinical Outcomes Data: For the in-vivo efficacy and safety studies, the ground truth was based on:
  • Major Complication Rates: Clinically diagnosed complications within 7 days post-procedure.
  • Ablation Success: Acute success (immediate outcome of the ablation procedure) and 90-day success (long-term absence of arrhythmia recurrence). These are definitive clinical endpoints.
  • Manipulation and Positioning: Demonstrated ability to reach pre-specified cardiac locations and achieve proper anatomical placement.
• Bench Testing Data: For mechanical, electrical, and sterility testing, ground truth was established by:
  • Measurements: Using instruments like a Hall Effect tesla meter for magnetic field strength.
  • Conformance to Standards: Meeting established engineering and safety standards (e.g., IEC 60601-1, ISO 62304, ISO 14971).
  • Pre-determined Requirements: The testing "demonstrated that the Niobe System met pre-determined requirements."
• Animal Model Data: For simulated-use testing, the animal studies likely provided physiological and anatomical ground truth for the performance of the system and software features.

8. The Sample Size for the Training Set

• The document refers to "software verification and validation activities" and "non-GLP animal validation studies" for specific software versions (Navigant 4.4, 5.0.1, 5.0.2, 5.0.3). These can be considered part of the development and testing process, but the document does not specify a distinct "training set" sample size in the context of an AI/machine learning model. The clinical studies (511 patients) would be considered the main validation or test set for clinical performance.

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

• As mentioned above, the concept of a "training set" in the context of AI/machine learning is not directly applicable here. For the non-clinical and animal studies used in development and validation:
  • Non-clinical (bench) testing: Ground truth was established through direct physical measurements, adherence to engineering specifications, and compliance with recognized standards.
  • Animal Validation Studies: The ground truth would have been established through controlled experimental conditions, physiological measurements, and post-procedure analysis (e.g., ablation lesion assessment).

In summary, this submission focuses on a mechanical-robotic system, not an AI diagnostic, thus many aspects related to AI performance metrics are not applicable. The core of the evidence relies on thorough non-clinical engineering validation and prospective human clinical trials demonstrating safety and efficacy.

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