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The RefStar™ RMT External Reference Patch is indicated for use with the NAVI-STAR™ RMT catheter and the CARTO™ RMT system to provide catheter tip location as well as electrogram information.

The RefStar RMT is an external reference catheter designed to be placed on the patient's back in order to compensate for movement during electrophysiology mapping of the heart. The back of the distal end of the RefStar RMT External Reference Patch has an adhesive backing, designed to be placed externally on the patient's back. The catheter contains a location sensor, that, when used together with the CARTO RMT system and the , NAVISTAR RMT Catheter provides catheter tip location information to construct a 3D electrophysiological maps of the human heart in the Stereotaxis Magnetic Navigation System magnetic field (K013484 and K021555) in real-time.

The provided text describes a 510(k) premarket notification for the RefStar RMT External Reference Patch. This device is seeking clearance based on substantial equivalence to a predicate device, not by proving efficacy via clinical trials with specific acceptance criteria. This means the submission doesn't contain a detailed study with acceptance criteria and device performance results in the way a novel device might.

Here's a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance

Based on the provided text, no specific quantitative acceptance criteria or detailed performance results (e.g., accuracy, precision) are explicitly stated for the RefStar RMT. The submission focuses on demonstrating substantial equivalence.

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" in the context of a clinical performance study. The testing mentioned is "bench testing under simulated use conditions." Therefore, no information on sample size for a test set or data provenance (country of origin, retrospective/prospective) is provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The document does not describe a clinical study requiring expert-established ground truth.

4. Adjudication method for the test set

Not applicable. The document does not describe a clinical study requiring adjudication.

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 surface reference patch for an electrophysiology system, not an AI-powered diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant to its clearance.

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

Not applicable. This device is a hardware component of a larger electrophysiology system and does not operate as a standalone algorithm.

7. The type of ground truth used

Not applicable in the context of a clinical performance study with "ground truth." The "truth" for this submission is the established performance and safety of the predicate device. The performance of the RefStar RMT was likely assessed against established engineering specifications and functional requirements to ensure it matched the predicate.

8. The sample size for the training set

Not applicable. The document does not describe a training set as this is not an AI/machine learning model.

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

Not applicable. The document does not describe a training set or its associated ground truth.

Summary of the Study (Bench Testing and Substantial Equivalence):

The RefStar RMT was cleared based on proving substantial equivalence to a predicate device, the Cordis-Webster RefStar™ External Surface Reference Device (K980961). The study described is bench testing under simulated use conditions. The core argument for safety and efficacy relies on:

• Identical Indication for Use: Both the RefStar RMT and the predicate device have the same indication for use: "to provide catheter tip location as well as electrogram information" when used with specific catheter and system components.
• Similar Design Requirements and Technological Characteristics: The new device meets the same design requirements and shares similar technological characteristics with the predicate.
• Functional Equivalence: Bench testing demonstrated that the devices are functionally equivalent. This would typically involve verifying that the new device performs its intended functions (e.g., providing location signals, electrical properties) within acceptable tolerances and in a manner consistent with the predicate.
• Compliance with Standards: The RefStar RMT complies with multiple external electrical and performance standards, although the specific standards are not listed.

Essentially, the "study" for this 510(k) was a comparison to an already cleared device, demonstrating that the new device performs its intended function similarly and does not raise new questions of safety or effectiveness.

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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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