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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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