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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.

This FDA 510(k) clearance letter for the Stereotaxis Niobe Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodrive (K192775) primarily references existing data from prior submissions and does not detail a new standalone clinical study. The submission relates to software modifications to an already cleared device, thus "special controls" testing and leveraging existing clinical data were used to demonstrate continued safety and effectiveness.

Here’s a breakdown of the acceptance criteria and the study information as presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document frames its "acceptance criteria" through how the device addresses a set of "Special Controls" established by the FDA for this class of device. The response to each control serves as the demonstration of meeting the criteria.

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

The document does not describe a novel "test set" in the context of typical AI/ML validation studies (i.e., a dedicated, novel set of cases exclusively for the purpose of algorithm validation). Instead, it relies heavily on retrospective clinical data from previously submitted studies and non-clinical engineering tests to demonstrate substantial equivalence for software modifications.

• Clinical Data (leveraged from prior submissions):
  • Total Patients: 511 patients (across 4 studies: ATTRAC, ATTRAC II, HEART Study, VERSATILE)
  • Attrition Data within Studies:
    • ATTRAC: 182 enrolled patients, 175/182 for acute success, 145/147 for 90-day success.
    • ATTRAC II: 80 enrolled patients, 71/75 for acute success, 51/54 for 90-day success.
    • HEART Study: 129 enrolled patients, 108/121 for acute success, 82/87 for 90-day success.
    • VERSATILE: 120 enrolled patients, 119/120 for acute success, "Not reported" for 90-day success.
  • Data Provenance: The studies were Stereotaxis-sponsored clinical trials, previously submitted to the FDA for other clearances (P050029, K071029, K140804). The country of origin for these studies is not specified in this document. These are prospective studies given the "enrolled patients" context and "7-day major complication rate".
• Non-Clinical Data (specific to this submission):
  • Software Verification and Validation: This involved internal testing by Stereotaxis under design controls. No specific "sample size" of software test cases is provided but it implies thorough testing.
  • Animal Studies: Four non-GLP animal validation studies were conducted. The number of animals is not specified, but these are prospective studies to validate specific software features and integration.

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

Not applicable in the traditional sense of image-based AI ground truth. The "ground truth" for the clinical efficacy and safety data primarily comes from the patient outcomes and procedural data recorded during the clinical trials themselves, which would be managed by the clinical investigators (physicians) and study staff.

For user assessment of device remote controls and safety features, it mentions "physician feedback forms." This implies physicians were the "experts," but the number and their specific qualifications are not detailed.

4. Adjudication Method for the Test Set

For the clinical studies, adverse events were generally reported and reviewed, and in the VERSATILE Study, it explicitly states that the "DSM adjudicated these events to be possibly and probably related to the procedure, respectively." DSM typically refers to a Data Safety Monitoring Board, which is an independent committee of experts (e.g., clinicians, biostatisticians) that monitors patient safety and treatment efficacy data during clinical trials. This suggests an adjudication method, at least for some adverse events.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI vs. Without AI Assistance

No MRMC study is mentioned. This submission is for a device that assists with navigation, not for an AI that interprets images or diagnoses conditions in a way that would typically involve multiple readers assessing cases. The device itself is the "AI" (automated navigation based on software). Comparative effectiveness is primarily drawn from historical controls or comparisons to manual procedures mentioned in the PMS section (e.g., complication rates vs. manual rates).

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device is a "Steerable Cardiac Ablation Catheter Remote Control System." Its core function is to automate or assist in catheter navigation, inherently requiring a human operator (physician) to interact with the system. Therefore, a standalone (algorithm only) performance study without human-in-the-loop is not directly relevant or performed for the primary function of controlling the catheter. However, the mechanical and electrical performance tests (Special Controls 1 & 2) represent isolated system performance without a human in the loop, validating individual components of the system.

7. The Type of Ground Truth Used

• Clinical Studies: Patient outcomes (acute success, 90-day success, complication rates) serve as the ground truth for safety and efficacy. This is primarily outcomes data, determined by clinical follow-up and assessments from physicians.
• Non-Clinical Studies: Ground truth for mechanical and electrical performance is established via measurement against engineering specifications and validated standards (e.g., THM-7025 Hall Effect tesla meter, IEC 60601 conformance).
• Animal Studies: The success of specific software features in animal models (e.g., successful targeting, ablation) serves as the ground truth. This is a form of experimental outcome data.

8. The Sample Size for the Training Set

This document does not describe the Niobe System as an AI/ML device in the modern sense (e.g., a deep learning model requiring a large training dataset of images or other raw data). The "software modifications" refer to updates to the control system. Therefore, there's no mention of a traditional "training set" size for an AI algorithm. The development of software would involve internal testing and validation, but not "training data" in the AI/ML context.

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

As no specific AI/ML training set is described, this question is not applicable. The traditional software development and verification/validation processes would have established "ground truth" through requirements documentation, test specifications, and expected outputs.

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The Vdrive® system is intended to stabilize, navigate and remotely control:

· Compatible Intracardiac Echocardiography (ICE) catheters to facilitate visualization of cardiac structure during the performance of cardiac procedure when used in conjunction with the V-Sono™ disposable sets in the Vdrive® system,

· Compatible loop (circular) mapping catheters to facilitate movement of the catheter during the performance of electrophysiological procedures when used in conjunction with the V-Loop™ disposable sets in the Vdrive® system, and

· Compatible fixed curve transseptal sheaths and catheters to facilitate movement of the sheath and catheter when used in conjunction with the V-CAS™ disposable sets in the Vdrive® system and with the Niobe® Magnetic Navigation System (MNS).

The Vdrive® with V-Sono™ disposable is indicated for remotely controlling the advancement, retraction, rotation and anterior-posterior deflection of compatible ultrasound catheters inserted into the right atrium. Compatible catheters at this time include Biosense Webster, Inc. Soundstar™ 3D Ultrasound Catheters and Acuson AcuNav™ Ultrasound Catheters. Other models of ICE catheters have not been tested with the Vdrive™ system.

The Vdrive® with V-Loop™ disposable is indicated to remotely control the advancement, retraction, tip deflection and loop size of compatible loop catheters inserted across the septum into the left atrium using conventional procedures. Compatible catheters at this time include Biosense Webster Lasso 2515 and Lasso 2515 NAV Circular Mapping Catheters. Other models of loop catheters have not been tested with the Vdrive® system.

The Vdrive® with V-CAS™ disposable is indicated for remotely controlling the advancement, retraction, and rotation of compatible fixed curve transseptal sheaths, and the advancement and retraction of compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System. Compatible fixed curve sheaths at this time include the St. Jude Medical® Transseptal Sheath and Swartz™ Braided Transseptal Sheath. Other models of transseptal sheaths and mapping/ablation catheters have not been tested with the Vdrive® system. Vdrive® with V-CAS™ is contraindicated for vascular access sites other than the groin. It is not intended to advance the EP mapping and ablation catheters through the coronary vasculature nor the coronary sinus. The transseptal sheath is not to be moved while the EP catheter is actively delivering therapy.

The Vdrive Duo™ is an optional accessory intended for remotely controlling the Vdrive® system when one arm of the device is equipped with one disposable set (V-Sono™, V-Loop™ or V-CAS™) and the other arm is equipped with a different available disposable set. During the procedure, the Vdrive Duo™ allows selection between the disposable sets.

Vdrive® with V-Sono™ is intended to control a compatible Intracardiac Echocardiography (ICE) catheter during and therapeutic cardiac procedures and is comprised of four major components:

1. Vdrive® Hardware - control box, adjustable arm, drive unit and support structure or Vdrive Duo™ (K133396) - with two adjustable arms
2. Vdrive® User Interface – combination of software-driven (a) Tableside Controller and (b) dedicated Vdrive® Controller
3. V-Sono™ Disposable Kit – Handle Clamps, Catheter Support Tube and Drape. These components are disposable, sterile, single use devices (K122659), including Vmotion™ functionality
4. V-Loop™ Disposable Kit (K140804)
5. V-CAS™ Disposable Kit (K141530)

The provided text describes the Stereotaxis Vdrive, Vdrive With V-sono (Vmotion), and Vdrive Duo system. Here's a breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance results in a quantitative manner. Instead, it describes general performance tests and states that the device "met its performance requirements" without providing specific metrics or thresholds.

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

• Animal Testing (for safety and effectiveness): The document states "an animal study in a porcine model." It does not specify the exact number of animals (sample size).
• Bench Testing: No specific sample sizes for bench tests are provided.
• Data Provenance: The animal study was conducted in a porcine model, indicating an animal study rather than human clinical data. The document implies these were prospective tests (bench and animal) conducted as part of the device's development and submission. No country of origin for the data is explicitly mentioned beyond the submitter's location (St. Louis, MO, USA).

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

This information is not provided in the document. The animal study evaluated the device's ability to perform movements, but it doesn't mention expert assessment of a "ground truth" in the way one might for diagnostic accuracy. The "ground truth" for the animal study appears to be the successful execution of programmed movements as per product requirements.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the tests (bench and animal), a clinical adjudication method in the traditional sense is unlikely to apply.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned in this document.
• The study described is an animal study and bench testing, focusing on the device's functional performance, not human reader performance with or without AI assistance.

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

• The document describes the device, including its "Vmotion control mode," which provides automated features like Spotlight, Sweep, and Stored Positions. These features imply an algorithm guiding the catheter movements.
• The "Performance data establish the substantial equivalence of the Vdrive® with Performance data V-Sono™, including software verification and validation data, bench performance testing and animal testing." The bench testing specifically included "software-controlled movements (Spotlight, Stored Position, and Sweep), which included testing for motion accuracy... motion limits... and motion safety..."
• This indicates that the performance of these automated/software-controlled movements (the "algorithm") was tested in a standalone manner (bench tests and animal study) to ensure they met specifications.

7. Type of Ground Truth Used

• For the bench testing, the ground truth appears to be the device's design specifications and predetermined performance requirements (e.g., specific sweep speeds, angles, limits, and safety stops).
• For the animal study, the ground truth was the device's ability to "perform movements of the ICE catheter tip according to product requirements," which aligns with predefined performance criteria and expected functional outcomes in a biological setting.

8. Sample Size for the Training Set

This information is not provided. The document describes a device with automated functions, but it does not detail any machine learning or AI models that would typically require a training set. The "Vmotion" features are described as "software-controlled movements," implying programmed logic rather than a trained AI model in the modern sense.

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

Since there is no mention of a "training set" or a machine learning model requiring one, this information is not applicable/provided.

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