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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

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Genesis MNS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart and coronary vasculature, neurovascular 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.

Stereotaxis Genesis RMN® with Navigant™ Workstation (NWS) and Cardiodrive® System (Genesis MNS) 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 using computer-controlled permanent magnets 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. Genesis MNS incorporates software that determines the direction the magnetic field should be applied based on physician interaction with the user interface devices.

Here's a summary of the acceptance criteria and study information for the Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System (Genesis MNS) based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

• ATTRAC: 7/182 (3.8%)
• ATTRAC II: 1/80 (1.3%)
• HEART Study: 7/129 (5.4%)
• VERSATILE: 5/120 (4.2%)
• Total: 20/511 (3.9%) |
  | In vivo testing (Efficacy - ablation success): | Acute Success RMN:
• ATTRAC: 175/182 (96.2%)
• ATTRAC II: 71/75 (94.7%)
• HEART Study: 108/121 (89.3%)
• VERSATILE: 119/120 (99.2%)
• Total: 473/498 (95.0%)
  90 day success RMN:
• ATTRAC: 145/147 (98.6%)
• ATTRAC II: 51/54 (94.4%)
• HEART Study: 82/87 (94.3%)
• VERSATILE: Not reported
• Total: 278/288 (96.5%) |
  | User assessment of device remote controls and safety features: | Same user assessment testing (device remote controls and safety features) as the predicate device was performed, and all safety features passed. |
  | Sterility of sterile disposable components: | Genesis System is not provided in sterile form. CardioDrive includes single-use disposable (QuikCAS) which underwent sterilization testing, resulting in a PASS. |
  | Shelf life of sterile disposable components: | Genesis System is not provided in sterile form. CardioDrive's single-use disposable (QuikCAS) underwent shelf-life/packaging and sterilization testing. All testing resulted in a PASS, and each component was validated for a shelf life of 3 years. |

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

The "test set" for clinical performance appears to be a collection of existing clinical studies that used the predicate device (Niobe MNS) and compatible components.

• Sample Size: A total of 511 patients were enrolled across 4 studies.
• Data Provenance: Clinical data from retrospective analyses of previously submitted studies to the FDA. These studies were sponsored by Stereotaxis. The specific countries of origin are not explicitly stated within the provided text, but these were part of FDA submissions (P050029, K071029, K140804) suggesting they are likely from clinical trials conducted in regions that align with FDA regulatory standards (e.g., US or international sites that adhere to similar clinical trial practices).

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

The document does not specify the number of experts used to establish the ground truth for the clinical outcomes (adverse events, acute success, 90-day success) in these studies, nor their specific qualifications. It mentions that "Clinical data to support the safety of the Magnetic Navigation System... was reviewed" and that "The DSM adjudicated these events to be possibly and probably related to the procedure, respectively" in the VERSATILE study. This suggests that a Data Safety Monitoring board or similar expert body was involved in reviewing adverse events.

4. Adjudication Method for the Test Set

For the VERSATILE study, adverse events were "adjudicated" by the DSM (Data Safety Monitoring board). The specific adjudication method (e.g., 2+1, 3+1) is not detailed, but it indicates an expert review process.

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

No MRMC comparative effectiveness study is mentioned in the document. The comparative effectiveness assessment for the Genesis MNS is primarily against its predicate device (Niobe MNS) and historical clinical data for both the MNS system and manual ablation.

• Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: Not applicable, as this is a robotic navigation system, not an AI-assisted diagnostic or interpretative device that augments human readers. The clinical studies compare outcomes of the magnetic navigation system to historical data or literature on manual ablation. The document states:
  • "More than 8,000 patients were reported in the literature using the MNS System with a major complication rate of 0.72% compared to a manual rate of 2.1%." (This implies a lower complication rate for MNS compared to manual.)
  • "Acute success rates and long-term success rates were similar in both the MNS and manual groups."

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

The device itself is a "Steerable Cardiac Ablation Catheter Remote Control System" and "Magnetic Navigation System," which is inherently designed for human-in-the-loop operation (a physician interacts with the user interface to control the magnetic field and system). Therefore, a standalone (algorithm only) performance study of the entire system as a diagnostic or interventional tool would not be relevant. The performance data presented focuses on the mechanical and electrical performance of the system and its clinical outcomes when used by an operator.

7. The Type of Ground Truth Used

The ground truth used for the clinical performance assessment consists primarily of:

• Clinical Outcomes Data: Major complication rates, acute success rates, and 90-day success rates, as recorded and adjudicated in the patient studies (ATTRAC, ATTRAC II, HEART, VERSATILE). These outcomes intrinsically serve as the "ground truth" for safety and efficacy in a clinical setting.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI. This device is a robotic system, and its development would typically involve engineering design, bench testing, and clinical validation rather than a distinct machine learning training phase. The "data" used for demonstrating its safety and effectiveness are the results from the various tests (mechanical, electrical, animal, and clinical studies of the predicate device).

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

As there is no explicitly defined "training set" in the context of AI/ML, this question doesn't directly apply. The establishment of "ground truth" related to the device's design and operation would have been through engineering specifications, physics principles governing magnetic fields, and established clinical endpoints for cardiac ablation procedures (e.g., successful ablation, absence of major complications).

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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 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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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 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 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 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-CAST™ is intended to control a compatible fixed curve transseptal sheath and catheter during diagnostic 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-CAST™ Disposable Kit – Handle Clamps, Catheter Support Tube and Drape. These components are disposable, sterile, single use devices.
4. V-Loop™ Disposable Kit (K140804)
5. V-Sono™ Disposable Kit (K122659)

The provided text appears to be a 510(k) summary for the Stereotaxis Vdrive, Vdrive with V-CAS, and Vdrive Duo systems. This document describes the device's intended use and performance data used to establish substantial equivalence to predicate devices, rather than a study designed to prove the device meets specific acceptance criteria in the context of an in-depth clinical performance evaluation for a high-risk device or AI/ML algorithm.

Specifically, the document outlines a premarket notification for a Class II medical device, which typically relies on demonstrating substantial equivalence to legally marketed predicate devices, often through non-clinical performance testing (bench, animal) and, if applicable, a review of existing clinical data or small, confirmatory clinical studies. The level of detail regarding acceptance criteria and ground truth establishment is much less stringent than what would be expected for a novel AI/ML device requiring robust clinical validation.

Based on the provided text, here's an attempt to answer your request, focusing on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly define a table of acceptance criteria with numerical targets for device performance in the same way an AI/ML study might, such as specific sensitivity, specificity, or AUC targets. Instead, it mentions that the device "met its performance and user requirements" through various tests and that the clinical study "supported the safety and effectiveness" of the system.

The closest we get to "performance" in a measurable sense for the V-CAS component is:

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

• Test Set (Clinical Data for V-CAS™): For the V-CAS™ disposable used with Vdrive Duo™, data was collected from 15 subjects in the VERSATILE Study.
• Data Provenance: The VERSATILE Study was a prospective, randomized multi-center clinical trial. No specific countries of origin are mentioned, but "multi-center" implies multiple clinical sites, likely within the US given the FDA submission. The study is cited with a ClinicalTrials.gov identifier (NCT01656772).

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

The concept of "ground truth" as typically applied to diagnostic AI/ML algorithms (e.g., expert consensus for image findings) is not directly applicable here. This device is a robotic catheter control system. Therefore, the "ground truth" or primary outcome measure in the clinical study was related to the clinical success of the procedure facilitated by the device and occurrence of adverse events.

• For the V-CAS™ disposable: The outcome was the achievement of electrical pulmonary vein (PV) isolation. This outcome would have been determined by the treating electrophysiologists using established clinical methods (e.g., electrophysiological mapping demonstrating no conduction). The study involved "investigators," who would be qualified medical professionals, most likely electrophysiologists. However, the specific number and qualifications are not detailed beyond "investigators."

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for establishing ground truth as might be done for image-based diagnostic decisions. For a procedural device, the primary "adjudication" would typically involve:

• Clinical assessment by the treating physician: The success of electrical PV isolation would be determined by the electrophysiologist performing the procedure based on real-time physiological data.
• Adverse event reporting and review: Safety outcomes would be documented and reviewed according to study protocols, likely by a clinical events committee or study monitors, but this isn't explicitly detailed as an adjudication method for defining "ground truth" in the diagnostic sense.

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

No, an MRMC comparative effectiveness study of human readers with vs. without AI assistance was not conducted and is not relevant to this device.

The clinical study (VERSATILE Study) was a prospective, randomized multi-center trial comparing the Vdrive® with V-Loop™ system to conventional manual methods of navigation for circular mapping catheters. This is a comparison of robotic assistance versus manual methods for catheter navigation, not an AI-assisted diagnostic task. The V-CAS™ component (the subject of this 510(k)) was evaluated for safety as part of the Vdrive Duo™ arm of this trial, but the primary comparison was for V-Loop™.

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

This device is fundamentally a "human-in-the-loop" system, as it is a remote control system for catheters operated by a physician. Therefore, a "standalone algorithm only" performance evaluation is not applicable. The device's function is to assist human control.

7. The Type of Ground Truth Used

The ground truth or primary outcome for the clinical evaluation of the V-CAS™ component (within the Vdrive Duo™ arm) was the clinical outcome of electrical PV isolation (a physiological/procedural outcome) and the occurrence of adverse events (safety outcome). This is distinct from "expert consensus," "pathology," or "outcomes data" in the sense of an independent, definitive diagnostic label. Rather, it's a measure of procedural success and safety during complex medical procedures.

8. The Sample Size for the Training Set

The document describes a 510(k) submission, which demonstrates substantial equivalence, not the development and training of an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The "training" for the device's development would involve engineering design, bench testing, and animal studies.

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

As there is no AI/ML training set, this question is not applicable. The device's functional integrity and safety were established through a combination of engineering specifications, bench testing, and animal studies.

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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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The Vdrive™ System is intended to stabilize, navigate and control compatible intracardiac echocardiography (ICE) catheters to facilitate visualization of cardiac structures during the performance of cardiac procedures when used in conjunction with Stereotaxis compatible V-Sono™ disposable sets in the Vdrive™ system. 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.

Vdrive™ with V-Sono™ is indicated for remotely controlling the advancement, retraction, rotation and anterior-posterior deflection of compatible ultrasound catheters inserted into the right atrium.

The Vdrive™ with V-Sono™ is comprised of three major components,

1. Vdrive™ Hardware - control box, adjustable arm, drive unit and support structure

2. Vdrive™ User Interface - combination of software driven (a) Tableside Controller and (b) dedicated Vdrive™ Controller

3. V-Sono™ Disposable Kit - Handle Clamps (w/catheter inserts), Telescoping Catheter Support and Drape. These components are disposable, sterile, single use devices.

The provided text describes a 510(k) summary for the Vdrive™ with V-Sono™ device. This document focuses on demonstrating substantial equivalence to a predicate device and includes performance data related to electrical safety, EMC compatibility, and software verification and validation. However, it does not contain specific acceptance criteria or a study detailing device performance against such criteria in the manner requested for AI/diagnostic devices.

Based on the provided text, here's what can be answered:

1. A table of acceptance criteria and the reported device performance

The provided document describes the device as being substantially equivalent to a predicate device (Vdrive™ with V-Sono™ K122659). The "Performance data" section states: "Changes were made under Design Controls to ensure that the modified device is as safe and effective as the predicate device and that the design outputs of the modified device meet the design input requirements. Performance testing for electrical safety, EMC compatibility and software verification and validation testing were performed."

This indicates that the acceptance criteria are implicitly tied to meeting the design input requirements and demonstrating safety and effectiveness comparable to the predicate device through:

• Electrical safety performance
• EMC compatibility performance
• Software verification and validation performance

The document does not provide specific quantitative acceptance criteria (e.g., specific thresholds for electrical leakage or EMC emissions) or detailed performance results (e.g., measured values) for these tests. It only states that these tests were "performed" and that the device was deemed "safe and effective for its intended use" based on the documentation.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not applicable. The document does not describe a test set or data provenance in the context of a clinical performance study using patient data. It refers to "performance testing for electrical safety, EMC compatibility and software verification and validation," which are engineering and software testing activities, not clinical trials with patient samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. As noted above, this document describes engineering and software testing, not a clinical study involving expert interpretation of medical data to establish ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. There is no mention of a test set requiring adjudication in the context of clinical performance.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a mechanical system for controlling intracardiac echocardiography catheters, not an AI or diagnostic imaging device that would typically undergo an MRMC study related to human reader performance with or without AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI algorithm. Its performance is inherent in its mechanical and software functions to control the catheter.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The performance testing mentioned (electrical safety, EMC, software V&V) uses engineering standards and software validation methods as their "ground truth," rather than clinical ground truth like pathology or expert consensus.

8. The sample size for the training set

Not applicable. This is not an AI device that would have a training set.

9. How the ground truth for the training set was established

Not applicable. As this is not an AI device, there is no training set or associated ground truth.

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The Vdrive™ System is intended to stabilize, navigate and control compatible intracardiac echocardiography (ICE) catheters to facilitate visualization of cardiac structures during the performance of cardiac procedures when used in conjunction with Stereotaxis compatible V-Sono™ disposable sets in the Vdrive™ system. 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.

Vdrive™ with V-Sono™ is indicated for remotely controlling the advancement, retraction. rotation and anterior-posterior deflection of compatible ultrasound catheters inserted into the right atrium.

The Vdrive™ with V-Sono™ is comprised of three major components,

1. Vdrive™ Hardware - control box, adjustable arm, drive unit and support structure
2. Vdrive™ User Interface - combination of software driven 1) Tableside Controller and 2) dedicated Vdrive™ Controller
3. V-Sono™ Disposable Kit - Handle Clamps (w/catheter inserts), Telescoping Catheter Support and Drape. These components are disposable, sterile, single use devices.

This 510(k) summary describes a medical device, the Vdrive™ with V-Sono™, which is a system intended to stabilize, navigate, and control compatible intracardiac echocardiography (ICE) catheters during cardiac procedures.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific quantifiable acceptance criteria for the device's performance nor does it report detailed performance metrics against such criteria in a table format.

Instead, it indicates that the device's performance was evaluated through:

• Comparative preclinical study: Conducted in animals with manual versus Vdrive™ manipulation of an ICE catheter using the V-Sono™ disposable.
• Performance testing for electrical safety, EMC compatibility, sterility, packaging, and verification and validation testing.

The conclusion drawn is: "Based upon the documentation presented in this 510(k) it has been demonstrated that the Vdrive™ with V-Sono™ device is safe and effective for its intended use." This is an overall statement of efficacy and safety rather than a report against specific, numerical acceptance criteria.

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

• Test Set Sample Size: The document mentions a "comparative preclinical study ... in animals." However, the exact number of animals (sample size) used in this preclinical study is not specified.
• Data Provenance: The study was a "preclinical study ... in animals." This suggests the data is preclinical/animal data, not human clinical data. The country of origin is not specified. It can be assumed to be prospective as it's a study designed to evaluate the device.

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. As it was an animal preclinical study, "ground truth" might refer to direct observation, imaging, or post-mortem analysis by veterinary or lab experts, but no details are given.

4. Adjudication Method for the Test Set

This information is not provided.

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

A MRMC comparative effectiveness study was not explicitly mentioned or described. The study mentioned is a "comparative preclinical study in animals with manual versus Vdriv™e manipulation of an Intracardiac Echocardiography (ICE) catheter." This is a comparison between two methods of catheter manipulation, but not a human reader study evaluating improved performance with AI assistance.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

The Vdrive™ with V-Sono™ is a system that physically manipulates catheters and has a user interface. It is described as remotely controlling catheter advancement, retraction, rotation, and deflection. Therefore, it inherently involves human interaction for operation and is not a standalone algorithm in the sense of an AI-only diagnostic tool. Its performance is tied to its mechanical and software functions under human control.

7. Type of Ground Truth Used

For the "comparative preclinical study in animals," the "ground truth" would likely be established through:

• Direct observation of catheter manipulation and visualization of cardiac structures.
• Imaging (e.g., the ICE images themselves, or other imaging modalities used to confirm catheter position/movement).
• Potentially pathological examination or other scientific methods to assess any adverse effects or successful manipulation in the animal models.

The document does not detail this, but the context of a preclinical animal study suggests these types of 'ground truth' would be relevant.

8. Sample Size for the Training Set

The document does not mention a training set sample size. This device is primarily a mechanical and software-controlled system, not an AI/machine learning device that typically requires extensive training data for its core function of catheter manipulation. The "software driven" user interface would involve verification and validation testing, but not a "training set" in the common AI sense.

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

As no training set is mentioned in the context of AI/machine learning, this information is not applicable/provided. The "ground truth" for the device's functional and safety testing would be based on engineering specifications, regulatory standards, and established medical principles.

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The Odyssey Workstation is an optional display and user interface package designed to consolidate the point of control of the Catheterization Lab.

The Odyssey Workstation is an optional (large screen) display and user interface package which allows the clinician to view multiple diagnostic tool screens (e.g. Navigant, X-Ray, ECG, Carto, etc.) in the catheter lab. on one large flat panel monitor to view and interpret a variety of sources on a single screen. There are multiple view formats available, and the clinician can customize layouts to facilitate their specific workflow.

Here's an analysis of the provided text regarding the Stereotaxis Odyssey™ Workstation, focusing on acceptance criteria and study information:

Stereotaxis Odyssey™ Workstation Acceptance Criteria and Study Information

The 510(k) summary for the Stereotaxis Odyssey™ Workstation does not explicitly define acceptance criteria in terms of numerical performance targets (e.g., sensitivity, specificity, accuracy) for a diagnostic device. Instead, the "acceptance criteria" are implied through the comparison of the device's characteristics to a legally marketed predicate device (the Odyssey™ Workstation in Catheter Lab w/Niobe MNS). The study described is a comparison of technological characteristics to demonstrate substantial equivalence, rather than a performance study aiming to meet specific numerical thresholds.

The primary "study" is a comparison of the proposed device's characteristics against a predicate device to affirm substantial equivalence regarding safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this submission (a display and user interface package, not a diagnostic algorithm), the acceptance criteria are based on functional and technical characteristics, demonstrating equivalence to the predicate device. The "reported device performance" is the proposed device's characteristics.

Note: The "Acceptance Criteria" column represents the characteristics of the predicate device that the proposed device aims to be substantially equivalent to or improve upon without raising new questions of safety or effectiveness. The "Reported Device Performance" column shows the characteristics of the proposed Odyssey Workstation. The differences (e.g., expanded display options, removal of "keypad controls only Navigant") are presented as improvements or modifications that do not alter the fundamental safety and effectiveness.

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

The document does not describe a traditional "test set" with a defined sample size of patient data. The evaluation is based on comparing the technical specifications and functional capabilities of the new Odyssey Workstation to those of the predicate device. Therefore, there is no patient or image data used for a test set. This is a technical comparison, not a performance study on clinical data.

Data Provenance: Not applicable, as there is no clinical data test set.

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

Not applicable. This submission concerns a display and user interface system, not an AI or diagnostic device requiring expert interpretation for ground truth establishment. The "ground truth" here is the confirmed functionality and technical specifications of the device itself and its predicate.

4. Adjudication Method for the Test Set

Not applicable. There is no test set or expert adjudication described.

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

No, an MRMC comparative effectiveness study was not done. The device is a display and user interface package, not a device that assists human readers in interpreting clinical cases.

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

Not applicable. The Odyssey Workstation is a display and control system for existing diagnostic tools, not an algorithm that performs a standalone diagnostic function. Its purpose is to consolidate existing information for a clinician, implying a human-in-the-loop scenario.

7. The Type of Ground Truth Used

The "ground truth" in this context is the verified technical specifications and functional capabilities of the device, confirmed through engineering design, testing, and comparison to the predicate device's established characteristics. It is not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI or machine learning algorithm and therefore does not have a "training set" in the conventional sense. Its functionality is based on software and hardware design, not data-driven learning.

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

Not applicable, as there is no training set.

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