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The Telstar® Magnetic Navigation System [TMNS] is intended to navigate a magnetic-tipped device through tissue to designated target sites in the right and left heart, coronary, peripheral, and neurovasculature by orienting the device tip in a desired direction.

The Stereotaxis Endovascular Guide Wire is intended to introduce and position over-the-wire catheters and other over-the-wire therapeutic devices within the neurovasculature, coronary and peripheral vasculature during PTCA or other intravascular interventional procedures.

The Telstar® Magnetic Navigation System [TMNS] is an interventional workstation for the intravascular navigation of a magnetic-tipped device through tissue to designated target sites in the right and left heart, coronary, peripheral, and neurovasculature. It combines a bi-planar fluoroscopy system with a computer controlled magnetic field generator, to provide both visualization and control of a magnetically actuated guidewire. The system employs magnetic fields to orient the guidewire.

The Stereotaxis Cronus® Modified is a steerable guidewire that has a nominal diameter of 0.014 in/0.36 mm and a nominal length of 210 cm or 300 cm. The guidewire is designed only for use in conjunction with a Stereotaxis Telstar® Magnetic Navigation System [TMNS]. The wire is configured with a tapered distal tip and an embedded magnet, which is used for navigating the wire through the vasculature. This device is sterilized with 100% ethylene oxide.

The provided document is a 510(k) summary for the Stereotaxis Cronus® Endovascular Guidewire and Stereotaxis Telstar® Magnetic Navigation System [MNS]. It describes the device, its intended use, and claims substantial equivalence to predicate devices based on performance data. However, the document does not contain the specific details required to fully address all parts of your request regarding acceptance criteria and the comprehensive study design.

Here's a breakdown of the information that can be extracted and what is missing:

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

The document mentions "Bench testing and pre-clinical and clinical in vivo testing demonstrate that the Stereotaxis Telstar® Magnetic Navigation System [TMNS] and the Cronus® Modified perform in an equivalent manner to the Stereotaxis Telstar® Magnetic Navigation System [TMNS], and the Stereotaxis Cronus® Predicate and the Boston Scientific TRANSEND™ EX Platinum Steerable Guide Wire predicate devices."

This statement confirms that performance data was gathered and compared to predicate devices for elements like:

• Navigational capabilities within the vasculature
• Ability to introduce and position over-the-wire catheters and therapeutic devices
• Compatibility with the Magnetic Navigation System

However, the document does not provide specific quantitative acceptance criteria (e.g., "must achieve X successful navigations out of Y attempts," "force to dislodge must be greater than Z Newton") nor detailed reported performance metrics (e.g., "average navigation time," "percentage of successful catheter placements," "specific force measurements"). It only states that the performance was "equivalent" to predicate devices.

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

The document mentions "pre-clinical and clinical in vivo testing," but does not specify the sample sizes used for these tests. It also does not provide information on the country of origin of the data or whether the studies were retrospective or prospective.

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)

The document does not provide any information regarding experts used to establish ground truth or their qualifications. Given this is a medical device for navigation, it's highly likely that medical professionals (e.g., interventional cardiologists, neurologists) would have been involved in assessing performance during in vivo testing, but this is not detailed in the summary.

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

The document does not specify any adjudication method used for the test set.

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

The document describes a medical device (guidewire and magnetic navigation system) for physical navigation, not an AI-assisted diagnostic or interpretative tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable in this context.

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

This refers to an algorithm for analysis or diagnosis. The Cronus® Guidewire and Telstar® MNS are physical devices used for interventional procedures, where a human operator is always in the loop. Therefore, a standalone algorithm-only performance assessment is not applicable in the context of this device. The "standalone" performance here would refer to the device mechanisms themselves, not an algorithm's output.

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

For a guidewire and navigation system, "ground truth" would likely involve objective measures of successful navigation, target site achievement, absence of damage to vessels, and functional success of the delivered therapeutic device. While clinical in vivo testing is mentioned, the specific type of ground truth used (e.g., confirmed catheter placement by fluoroscopy, absence of complications observed by clinical review, successful therapeutic outcome) is not explicitly detailed in this summary.

8. The sample size for the training set

The document does not mention a training set. This is expected as the device is not an AI/ML diagnostic or predictive algorithm that requires a "training set" in the typical sense. Performance validation for such a physical device usually relies on pre-clinical and clinical testing, not a dataset-based training approach.

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

Since no training set is mentioned or implied for this type of device, this question is not applicable.

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, which is the primary goal of a 510(k) submission. It broadly states that performance testing occurred and showed equivalence. However, it does not delve into the detailed methodological aspects of the studies, such as specific acceptance criteria, sample sizes, expert qualifications, or detailed ground truth determination, which would be expected for a comprehensive study report.

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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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The Niobe MNS is intended to navigate a magnetic device 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 Niobe Magnetic Navigation System [MNS] 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 provided text describes the Niobe Magnetic Navigation System (MNS) and its substantial equivalence to a predicate device, the Telstar MNS. However, it does not contain specific acceptance criteria or a detailed study outlining quantitative performance metrics.

Based on the provided information, here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly stated in the provided text. The document focuses on demonstrating substantial equivalence to a predicate device rather than defining new performance acceptance criteria. It only mentions:

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

• Test Set Sample Size: "three canine studies" are mentioned as demonstrating performance. No specific number of canines or individual test cases within those studies is provided.
• Data Provenance: Prospective animal studies (canine). The country of origin is not specified but implicitly assumed to be the USA given the FDA submission.

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

This information is not provided in the document. The studies were described as "performance" studies, implying measurement of the device's ability to navigate, but the method of establishing ground truth (e.g., target achievement confirmation) and the role of human experts in this process are not detailed.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of Human Readers Improvement with AI vs. Without AI Assistance

This information is not applicable/not provided. The Niobe MNS is a navigation system, not an AI-assisted diagnostic or interpretation tool for human readers. Its purpose is to steer a catheter, not to aid in interpretation of images by human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device.

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

The device is an "interventional workstation for the navigation of appropriately equipped, magnetically adapted, devices... through tissue to designated target sites." It relies on a "computer-controlled" system but is ultimately used by a physician for "remote tableside physician control." Therefore, it's not a purely standalone algorithm; it's an assistive technology where human-in-the-loop interaction is inherent to its intended use. The performance studies would have evaluated the system's ability to facilitate navigation, which implies its interaction with a user to achieve an outcome.

7. The Type of Ground Truth Used

The text does not explicitly state the type of ground truth used for the performance studies in canines. Given it's a navigation system, potential ground truth elements could include:

• Reached Target Site: Verification that the catheter tip reached the designated target in the heart or coronary vasculature. This could be confirmed by imaging (e.g., fluoroscopy) and/or post-mortem examination.
• Navigation Accuracy: Measurement of the deviation of the steered device from the intended path.
• Procedural Success: Broader outcomes like successful completion of a simulated procedure within acceptable parameters (e.g., time, safety).

However, the specific methods are not detailed.

8. The Sample Size for the Training Set

This information is not provided in the document. Magnetic navigation systems rely on physical principles and control algorithms, which typically don't involve "training sets" in the same way machine learning models do. Any internal calibration or algorithm development data would not typically be referred to as a "training set" in this context.

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

As no "training set" is described for this type of device, this information is not applicable/not provided. The performance capabilities would be derived from engineering design, physics principles, and iterative testing/refinement rather than a data-driven "ground truth" for training.

Summary of Study Information:

The core of the "study" demonstrating the device meets acceptance criteria (implicitly, substantial equivalence to the predicate device) is described as:

• Performance testing: "Performance testing has demonstrated substantial equivalence of the new device to the predicate device."
• Canine Studies: "Performance of the Niobe MNS was demonstrated in three canine studies."
• Preclinical Data: "Clinical data are not necessary to support the modifications. Clinical application data for magnetic navigation were provided in K013484 (for the predicate device)."

Essentially, the device's performance was evaluated in animal models to show it could achieve its intended purpose (navigating a magnetic device) in a manner comparable to the predicate device. Specific quantitative metrics, sample sizes beyond "three canine studies," and details on ground truth establishment are not disclosed in this 510(k) summary.

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