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The Navigant™ Navigation Workstation 2.1 [NWS2] is a component of the Niobe® MNS. The Niobe® MNS with NWS2 is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart and coronary vasculature by orienting the device tip in a desired direction. The Navigant™ feature provides an enhanced navigation interface for the physician to control the MNS.

The Niobe® Magnetic Navigation System [NMNS] is an interventional workstation for the navigation of appropriately equipped, magnetically adapted, devices (e.g., catheters or guidewires) through tissue to designated target sites. The system uses computer-controlled permanent magnets for orienting the tip of a magnetic device. The system employs magnetic fields to orient or steer the tip of a magnetic device. The Navigant Navigation Workstation 2.1 [NWS2] is a modification to the Niobe® Magnetic Navigation System (K021555). The changes introduce a new software design and mode of operation, but maintain the existing technology for orientation of magnetically-adapted devices and clinical utility. The NWS2 is a subsystem of the MNS, and requires both an MNS and a digital fluoroscopy system to function properly.

The provided text describes a modification to an existing device, the Niobe® Magnetic Navigation System (MNS), introducing the Navigant™ Navigation Workstation 2.1 (NWS2). The submission focuses on demonstrating substantial equivalence to the predicate device, not on presenting novel performance data based on new acceptance criteria. Therefore, several of the requested categories are not applicable or cannot be extracted from this specific document.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present specific acceptance criteria or performance metrics in a quantitative table format for the NWS2 device. Instead, it relies on demonstrating substantial equivalence to a predicate device (Niobe® MNS, K021555). The "performance" described is that the new device performs in a functionally equivalent manner regarding steering control.

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

This document states that "Animal and clinical data are not necessary to support the modifications." The Navigant™ Navigation Workstation 2.1 (NWS2) is presented as a software/interface modification to an existing system, rather than a new device requiring extensive animal or clinical testing for its own predicate. Therefore, there is no specific test set sample size or data provenance provided for the NWS2 itself in this submission. The historical data from the predicate devices (K013484 & K021555) are referenced but not detailed here.

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

Not applicable. As noted above, animal and clinical data were not deemed necessary for this specific modification submission. Therefore, no ground truth establishment by experts for a new test set is described.

4. Adjudication Method for the Test Set

Not applicable. No new test set requiring expert adjudication is described in this submission.

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 is not a diagnostic AI device or a device involving human "readers" or AI assistance in interpretation. It's a navigation system for interventional procedures controlled by a physician.

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

Not applicable. The Niobe® MNS with NWS2 is an interventional workstation that requires a human physician in the loop to control the magnetic devices for navigation. Its function is to facilitate physician control.

7. The Type of Ground Truth Used

Not applicable for the NWS2 modification. The submission relies on the established safety and effectiveness of the predicate Niobe® MNS (K021555) and the Telstar® Magnetic Navigation System (K013484), which involved previous animal and clinical data. For the modification itself, the "ground truth" seems to be that the updated software provides an "enhanced navigation interface" while maintaining the existing technology and clinical utility of the predicate device, confirmed through "physical testing" (which is not detailed).

8. The Sample Size for the Training Set

Not applicable. This document pertains to a device modification and substantial equivalence. It does not describe an AI/machine learning model that requires a training set in the conventional sense.

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

Not applicable. As mentioned, this is not an AI/ML submission requiring a training set with established ground truth.

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