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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 Amigo™ Remote Catheter System (RCS) is intended to facilitate manipulation, positioning and control of compatible percutaneous electrophysiological ablation catheters that deliver RF energy in the right atrium. Use of Amigo RCS should also be in accordance with the indications for use of compatible ablation catheters. The Amigo RCS should only be used with the Boston Scientific catheters (with the Blazer" " handle) and/or the Biosense Webster catheters (with the EZ Steer® handle) in the right atrium.

The Amigo™ Remote Catheter System (Amigo RCS) is designed to facilitate the manipulation, positioning and control of compatible cardiac electrophysiological catheters. It is designed to remotely control Boston Scientific catheters (with the Blazer™ handle) and Biosense Webster catheters (with the EZ STEER® handle).

The Amigo RCS consists of four (4) main reusable, non-sterile components including the remote catheter system (sled, track, and turret), a hard-wired remote control, 100 ft extension cable, and a bridge support with rail and frame. In addition, the Amigo RCS includes three (3) sterile, single-use disposable kits including the docking station and spreader) to interface with the compatible ablation catheter, and a sterile cover kit (sled cover, turret cover, nose sleeve and side covers) and track kit (track and nosecone) used to maintain a sterile field during device use. The Amigo RCS is intended to attach to the rails of an IEC 60601-1 compliant EP bed system.

The Amigo RCS only interfaces with the catheter's handle such that the Amigo RCS connects to and operates the manual handle of the compatible steerable cardiac ablation catheter to remotely control its advancement, retraction, rotation, and deflection.

Here's a breakdown of the acceptance criteria and the study details for the AMIGO REMOTE CATHETER SYSTEM based on the provided text:

Acceptance Criteria and Reported Device Performance

For non-clinical mechanical performance testing:

For non-clinical electrical performance testing:

For clinical performance (three prospective cohort studies):

Study Details

1. Sample Size and Data Provenance

• Clinical Studies:
  • Sample Size: 85 patients in total across three clinical studies.
  • Data Provenance: Not explicitly stated, but likely from the US where FDA approval is sought. The studies were described as "3-center study" and "single-center studies," implying medical centers where the procedures were performed. The studies were prospective.
• Non-Clinical (Animal) Study:
  • Sample Size: Not specified.
  • Data Provenance: Not specified, but generally conducted by the manufacturer or a contract research organization.

2. Number of Experts Used to Establish Ground Truth and Qualifications

• Clinical Studies:
  • The document implies that acute procedural success and chronic success were assessed by the treating physicians and follow-up clinical assessments. There's no mention of a separate panel of experts establishing "ground truth" for the outcomes in the same way one might for diagnostic imaging interpretation. The outcomes (absence of arrhythmia recurrence, procedural success) are clinical endpoints based on established diagnostic criteria.
• Non-Clinical Studies:
  • Not applicable in the same way as clinical or diagnostic studies. Performance was measured against engineering specifications and observed by testing personnel/engineers.

3. Adjudication Method

• Clinical Studies:
  • No specific adjudication method (e.g., 2+1, 3+1) is mentioned for the clinical outcomes (acute/chronic success, adverse events). The text notes "limited rigor in adverse event detection, documentation and adjudication," suggesting that a highly structured adjudication process by independent experts may not have been a primary component of these studies.
• Non-Clinical Studies:
  • Not applicable.

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

• No, an MRMC study was not explicitly conducted for the Amigo RCS. The clinical studies compared Amigo RCS-controlled ablation to manual ablation, but largely focused on patient outcomes and operator fluoroscopy time. There is no mention of a "multi-reader multi-case" design typical for evaluating diagnostic performance where multiple readers interpret cases for a ground truth.
• Effect Size of Human Readers Improvement with AI vs Without AI Assistance: Not applicable, as this device is a robotic catheter control system, not an AI-assisted diagnostic tool for human readers. Its benefit to the human operator is reduced radiation exposure, not improved diagnostic accuracy.

5. Standalone Performance

• Yes, a standalone (algorithm only without human-in-the-loop performance) was done for the mechanical and electrical tests. The device's mechanical and electrical functionalities were tested independently and in conjunction with compatible catheters to ensure it met performance specifications. The "Amigo RCS does not impact catheter function and performance" and "Accuracy and function of all device electrical controls" were assessed in non-clinical settings.

6. Type of Ground Truth Used for Test Set

• Clinical Studies:
  • Acute/Chronic success: Clinical endpoints (e.g., absence of arrhythmia recurrence based on follow-up evaluations using standard clinical diagnostic methods for arrhythmias).
  • Adverse events: Clinical diagnosis and documentation of events by medical staff and follow-up.
• Non-Clinical Studies:
  • Mechanical/Electrical Performance: Engineering specifications, measured physical parameters (e.g., 1° difference in catheter throw).
  • Animal Studies: Observed functionality, performance, and tip placement in an in vivo model.

7. Sample Size for Training Set

• The document does not specify a separate "training set" sample size in the context of device development or machine learning. This is a robotic control system, not a machine learning model that is "trained" on data in the same way. The development and refinement of the system would have involved iterative design, bench testing, and animal studies, which are analogous to a development/validation process but not a "training set" in the common AI sense.

8. How Ground Truth for Training Set Was Established

• As above, the concept of a "training set" in the context of a machine learning model isn't directly applicable here. The "ground truth" during the development phase would have been established by engineering specifications, performance targets, and preclinical testing results informing the design and functionality of the robotic system.

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