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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 CorPath 200 System is intended for use in the remote delivery and manipulation of coronary guidewires and balloon/stent catheters during percutaneous coronary intervention (PCI) procedures.

The CorPath 200 System is intended for use by physicians in the delivery and manipulation of coronary guidewires and balloon/stent catheters during percutaneous coronary intervention ("PCI") procedures. The CorPath 200 System allows the physician to deliver and manipulate guidewires and balloon/stent catheters through the coronary vasculature under angiography-assisted visual guidance using computer controlled movements while in a seated position and away from the radiation source.

The CorPath 200 System is composed of two functional sub-units; the Bedside Unit and the Remote Workspace. The Bedside Unit consists of the Articulated Arm, the Robotic Drive and the single-use Cassette. The Remote Workspace consists of the Interventional Cockpit (radiation shield) which houses the Control Console, as well as angiographic monitor(s). Commercially available guidewires and balloon/stent catheters are loaded into the single-use Cassette. By using the joysticks or touch screen of the Control Console, the physician can send commands to the Robotic Drive via a communication cable that advances, retracts or rotates the guidewire, and/or advances or retracts the balloon/stent catheters. The CorPath 200 System's software continuously monitors the communication between the Control Console and the Robotic Drive and alerts the physician if any communication error occurs.

Here's a breakdown of the acceptance criteria and study information for the Corindus CorPath® 200 System based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly list "acceptance criteria" with specific thresholds in a tabular format. Instead, it presents the results of a clinical study that demonstrates the device's acceptable performance. The key performance metrics and their reported outcomes are summarized below:

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The CARTO® 3 System V3.0 is intended for catheter-based atrial and ventricular mapping. The mapping system allows real-time display of cardiac maps in a number of different formats. Maps may be displayed as anatomical maps, cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical potential maps, impedance maps, cardiac chamber geometry maps and ECG fragmentation maps. The acquired patient signals, including body surface ECG and intracardiac electrograms, may also be displayed in real time on the system's display screen. The CARTO® 3 System V3.0 is also intended to support EP procedures, maintaining CARTO® System capabilities in the presence of a high metallic environment and magnetic field strengths up to 0.1 T and provide a data communication channel to the Stereotaxis Niobe Catheter Navigation System. The CARTO® 3 System V3.0 includes CARTOMERGE® PLUS Module functionality to import, register and merge CT or MRI structural images with CARTO map's physiological information and real time catheter navigation. The system includes the Fast Anatomical Mapping (FAM) functionality that allows for the quick creation of cardiac anatomical volumes using catheters with magnetic location sensors. The system's CARTOSOUND® image integration functionality enables integration of intracardiac echo (ICE) to enable visualization of 3D combined maps. A fluoro background capability enables visualization of X-ray images as reference to the CARTO® Maps images and catheters. In addition to the use of specialized navigation catheters with magnetic location sensors, the system is also intended for use with conventional, non-navigational, electrophysiology catheters without magnetic location sensors.

The CARTO® 3 System V3.0 is a catheter-based atrial and ventricular mapping system designed to acquire and analyze data points, and use this information to display 3D anatomical and electroanatomical maps of the human heart in real-time. The location information needed to create the cardiac maps and the local electrograms are acquired using a specialized mapping catheter and reference device. The system allows realtime display of electrograms and cardiac maps based on the received intra cardiac signals from the catheters in a number of different formats. The acquired patient signals, including body surface ECG and intracardiac electrograms (IECG) may also be displayed on the display screen. The CARTO® 3 System V3.0 uses two distinct types of location technology - magnetic sensor technology and Advanced Catheter Location (ACL) technology.

Here's an analysis of the provided text regarding the acceptance criteria and study proving device efficacy, structured according to your request:

It's important to note that the provided text is a 510(k) Summary for a medical device (CARTO® 3 System V3.0), which focuses on demonstrating substantial equivalence to a predicate device rather than outright proving effectiveness in a clinical trial with specific performance metrics against a predefined acceptance criterion. As such, some of the requested information (like effect size of AI assistance, sample size for training sets, or detailed ground truth establishment for specific metrics) may not be explicitly present because the submission's goal is different.

Acceptance Criteria and Device Performance Study (CARTO® 3 System V3.0)

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) submission for the CARTO® 3 System V3.0 focuses on substantial equivalence to its predicate device (CARTO® 3 EP Navigation System, Version 2.2) and two reference devices. Instead of explicit quantitative "acceptance criteria" with specific performance metrics (e.g., sensitivity, specificity, accuracy against a numerical threshold), the criteria are framed around demonstrating that the new features work as intended and do not negatively impact existing features, making it "as safe, as effective, and performs as well as or better than" the predicate.

Therefore, the "acceptance criteria" are implied by the comprehensive non-clinical testing performed, and the "reported device performance" is a general statement of successful completion of these tests.

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

The document states: "The CARTO® 3 System V3.0 underwent extensive Bench and Animal Testing to verify the modified features and to demonstrate with regression testing that the new features did not negatively affect existing features."

• Test Set Description: "Bench and Animal Testing."
• Sample Size: Not specified in the provided text. The term "extensive" is used but no numerical count of tests performed, data points, or animals used is given.
• Data Provenance (Country of Origin, Retrospective/Prospective): Not specified. Animal testing is typically prospective, but bench testing methodology details are absent.

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

The 510(k) summary does not mention the use of human experts to establish ground truth for test sets. The testing described is primarily technical and functional ("Bench and Animal Testing") rather than clinical performance evaluated by human readers against a gold standard.

4. Adjudication Method for the Test Set

No adjudication method is described, as the testing performed was primarily technical/functional and animal testing, not human expert interpretation of device output.

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

No, an MRMC comparative effectiveness study is not mentioned in the provided 510(k) summary. The submission focuses on substantial equivalence via non-clinical testing. Therefore, there's no reported effect size of how much human readers improve with AI vs. without AI assistance. The device is a "Cardiac mapping system" and "Programmable diagnostic computer," which primarily assists electrophysiologists by providing real-time maps and data, rather than an AI-driven diagnostic tool designed for human-in-the-loop diagnostic improvement in the sense of image interpretation.

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

The device itself is a "Cardiac mapping system" and "Programmable diagnostic computer." Its primary function is to acquire, analyze, and display data for a physician's use in real-time procedures. The "Non-Clinical Performance Testing" described (Bench and Animal Testing) can be considered a form of standalone testing in that the device's technical specifications and functionalities were verified independently. However, this is not "standalone performance" in the context of an AI diagnostic algorithm's ability to interpret medical data without human intervention. The device's output (cardiac maps, electrograms) requires interpretation and action by a clinician, so there isn't a "standalone" diagnostic output in the way one might consider an AI-driven image analysis tool.

7. The Type of Ground Truth Used

For the "Bench and Animal Testing," the ground truth would be established through a combination of:

• Technical Specifications: Verification against predefined engineering and performance specifications.
• Physical Measurements & Known Conditions: In bench testing, this involves using phantoms, known electrical signals, or controlled environments where the "true" values are known and the device's measurements are compared against them.
• Physiological Observations (Animal Testing): In animal studies, ground truth would be based on direct physiological measurements, observations of physical effects, or pathological findings where applicable. The goal is to see if the device accurately reflects the physiological state of the animal heart.

8. The Sample Size for the Training Set

Not applicable/Not mentioned. The CARTO® 3 System V3.0 is a hardware/software system for cardiac mapping, not an AI/ML device in the modern sense that typically relies on large "training sets" for model development. Its functionalities are based on established biophysical principles and algorithms for signal processing and 3D reconstruction, rather than machine learning from a specific training dataset in the same way a diagnostic AI algorithm would be.

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

Not applicable/Not mentioned for the reasons stated above (not an AI/ML device relying on "training sets").

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The Guided Medical Positioning System (gMPS™) is intended for the evaluation of vascular and cardiac anatomy. It is intended to enable real time tip positioning and navigation of a gMPS™ enabled (equipped with a gMPS™ sensor) diagnostic or therapeutic invasive device used in vascular or cardiac interventions in the Cath Lab environment, on both live fluoroscopy or recorded background. The System is indicated for use as an adjunct to fluoroscopy.

The gMPS™, used in conjunction with an X-ray System, employs magnetic positioning technology to track a gMPS™ enabled diagnostic or therapeutic invasive device for the 3D position relative to any X-ray image, in real-time or previously recorded cine-loop.

The gMPS™ system is intended to provide the following:

Catheter tip positioning and navigation - The real time position of the gMPSTM sensor (and thus of the gMPS™ enabled device) is displayed in real time ("Live") fluoroscopy mode or in a recorded mode.

Smart trace (foreshortening indication) - A 3D trace of the gMPS™ enabled device trajectory is projected and superimposed on the 2D X-ray images (either on live fluoroscopy, recorded cine-loop or recorded still image).

3D reconstructed model - The system reconstructs a 3D model of the inspected anatomical structure.

Quantitative longitudinal measurements - The measurements are based on the 3D trace, thus overcoming length measurement errors induced by the foreshortening effect.

Quantitative Coronary Angiography (OCA) - While working in conjunction with gMPSTM enabled coronary device, the gMPS™ provides 3D QCA.

Virtual landmarking - A manually marked point or region of interest superimposed on X-ray images (real-time angiography and cine-loop) and on the 3D reconstruction.

Here's a breakdown of the acceptance criteria and study information for the Guided Medical Positioning System (gMPS™), based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly list quantitative acceptance criteria or specific performance metrics with target values. Instead, it makes a general statement about performance testing.

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

The provided text does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "Performance testing was conducted."

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

The provided text does not specify the number of experts used or their qualifications for establishing ground truth for the test set.

4. Adjudication Method for the Test Set

The provided text does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set.

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

The provided text does not mention if a multi-reader multi-case (MRMC) comparative effectiveness study was conducted. Therefore, no effect size of human readers improving with AI vs. without AI assistance can be determined from this document.

6. Standalone (Algorithm Only) Performance Study

The provided text describes the device's function as "real time tip positioning and navigation" and states "Performance testing was conducted in order to demonstrate the performance and accuracy of the gMPS™ and to verify that it does not raise any new safety and effectiveness issues in comparison to its predicate devices." This implies that the algorithm's performance in guiding the device was evaluated, which aligns with a standalone performance study. However, specific details of this study are not provided.

7. Type of Ground Truth Used

The provided text does not explicitly state the type of ground truth used (e.g., expert consensus, pathology, outcomes data). Given the device's function for "real time tip positioning and navigation" and "3D reconstructed model" of anatomical structures, it's highly likely that ground truth would involve either:
* Direct measurement/imaging: Comparing the system's reported position/reconstruction to a known physical measurement or a high-accuracy imaging modality.
* Expert validation: Clinical experts confirming the accuracy of the system's output against their anatomical knowledge or other reference images.

8. Sample Size for the Training Set

The provided text does not specify the sample size for the training set.

9. How Ground Truth for the Training Set Was Established

The provided text does not specify how ground truth for the training set was established.

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