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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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The Vdrive™ system is intended to stabilize, navigate and remotely control:
• 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.
• 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.

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

The Vdrive™ with V-Loop™ is provides a remote method of controlling the advancement, retraction, rotation, tip deflection, and loop size of a LASSO® Circular Mapping catheter during electrophysiology 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 1) Tableside Controller and 2) dedicated Vdrive™ Controller,
3. V-Loop™ Disposable Kit – Handle Clamps (w/catheter inserts), Telescoping Catheter Support and Drape. These components are disposable, sterile, single use devices, and
4. V-Sono™ Disposable Kit (K122659) if Vdrive Duo™ will be used.

The STERETAXIS Vdrive™ with V-Loop™ and Vdrive Duo™ system is a catheter control system designed to stabilize, navigate, and remotely control compatible loop mapping catheters and Intracardiac Echocardiography (ICE) catheters during electrophysiological and cardiac procedures, respectively. The following information details the acceptance criteria and the study proving the device meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state quantitative acceptance criteria in a table format. However, based on the performance data section, the implicit acceptance criteria are:

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

The primary clinical study supporting efficacy and safety was a prospective, randomized multi-center clinical trial.

• Sample Size: A total of 137 subjects were randomized.
  • Vdrive Group: 77 subjects
  • Control (Manual) Group: 43 subjects
  • (Note: The total of 77 + 43 = 120 subjects is less than the stated 137 randomized subjects. This may indicate some exclusions post-randomization or that 137 was the total randomized and 120 subjects actually underwent the procedure for data collection).
  • Vdrive Duo™ specific performance: 33 subjects used Vdrive Duo™ in the VERSATILE trial.
• Data Provenance:
  • Country of Origin: Not explicitly stated, but given the FDA review and the company being based in St. Louis, MO, USA, it is highly likely the clinical sites were in the United States.
  • Retrospective or Prospective: Prospective. The study is described as a "prospective, randomized multi-center clinical trial."

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

The document does not describe the establishment of a "ground truth" in the typical sense of expert annotation for an AI device. This is a medical device for catheter control, and the "ground truth" for its performance would be the clinical outcomes and procedural success, evaluated by the participating physicians.

• The study was a randomized clinical trial comparing the device to manual navigation. The clinical outcomes (e.g., efficacy of PV isolation, safety profile) were the direct measures of performance, as assessed by the clinical trial investigators.
• The qualifications of the experts (physicians) performing the procedures and assessing outcomes are implicitly assumed to be board-certified electrophysiologists, as they are conducting complex EP studies and ablation procedures. However, their specific qualifications (e.g., years of experience) are not detailed in this summary.

4. Adjudication Method for the Test Set

The document does not describe an explicit "adjudication method" for the clinical trial data in the way one might for image interpretation studies (e.g., 2+1, 3+1). Clinical trial data for efficacy and safety would typically be collected and analyzed according to a predefined statistical analysis plan, with internal and external monitoring to ensure data integrity. Adverse events would be reported and reviewed by the investigators and potentially an independent Data Safety Monitoring Board (DSMB), but this is not typically referred to as "adjudication" in the same context as ground truth establishment for AI.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not conducted in the context of human readers improving with AI assistance. The study was a clinical trial comparing a device-assisted procedure (Vdrive™ with V-Loop™) directly against a manual procedure, not an evaluation of how AI assistance impacts human interpretation. Therefore, there is no mention of an effect size for human readers improving with AI vs. without AI assistance.

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

No, this is a robotic catheter control system, not an AI algorithm for diagnostic interpretation. The device's function is to assist in real-time catheter manipulation. Therefore, a "standalone algorithm only" performance evaluation is not relevant or applicable for this type of medical device. The device's performance is inherently tied to its use by a human operator in a procedural context.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance was established through:

• Clinical Outcomes/Procedural Success: In the randomized clinical trial, the effectiveness was measured by the ability to achieve the procedural goal (e.g., PV isolation where a circular mapping catheter is used to evaluate PVs), with non-inferiority to the manual method as the success criterion.
• Safety Profile: Comparison of adverse events between the device and control groups.
• Performance Requirements: Meeting specific technical "performance and user requirements" evaluated in bench and animal testing.

It is a performance-based ground truth, not an "expert consensus," "pathology," or "outcomes data" in the typical AI diagnostic context, but rather a direct assessment of the device's ability to perform its intended function safely and effectively in a clinical setting compared to standard of care.

8. The Sample Size for the Training Set

This document describes a premarket notification (510(k)) for a medical device that is not an AI/ML-driven diagnostic or therapeutic algorithm that relies on a "training set" of data for its core function. The device is a robotic control system. Therefore, the concept of a "training set" as it applies to machine learning models is not relevant here, and no such sample size is reported.

The "training" for this device would refer to the developmental and testing phases, including bench testing, animal studies, and the clinical trial, which validate its mechanical and software functions as designed.

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

As explained in point 8, the concept of a "training set" and its "ground truth" in the context of machine learning does not apply to this robotic catheter control system as described in the provided document. The device's functionality is based on engineering principles and validated through a traditional medical device development pathway (bench, animal, and human clinical studies) rather than a data-driven model learning from a labeled training set.

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