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The Niobe® MNS with Navigant™ NWS is intended to navigate a magnet-tipped device through tissue to designated target sites in the right and left heart, coronary vasculature, neurovasculature and peripheral vasculature by orienting the device tip in a desired direction.

The Stereotaxis Niobe® MNS with Navigant™ NWS 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 system uses computer-controlled permanent magnets for orienting the tip of a magnetic device. It is important to note that the system employs magnetic fields only to orient or steer the tip of a magnetic device.

The Niobe® MNS with Navigant™ NWS is an interventional workstation designed for the intravascular navigation of magnetic devices. The referenced document (K060967) does not contain a typical "acceptance criteria" table with specific quantitative benchmarks for performance metrics (like sensitivity, specificity, accuracy, etc.) that would typically be found for diagnostic or screening devices.

Instead, the submission primarily focuses on demonstrating substantial equivalence to predicate devices for expanded indications. The "performance data" section describes a clinical study that was used to support this claim, rather than detailing specific acceptance criteria the new device had to meet.

Here's an analysis based on the provided text, focusing on how the device "meets acceptance criteria" through substantial equivalence and the study cited:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, there isn't a conventional table of acceptance criteria with quantified performance metrics for the Niobe® MNS with Navigant™ NWS itself in this document. The "acceptance criteria" for this 510(k) submission appear to be centered around demonstrating that the device is substantially equivalent to predicate devices for its expanded indications, particularly given the new neurovasculature indication.

The primary "performance" that is reported in support of this is the safety and efficacy of magnetically guided devices when used in the neurovasculature, as demonstrated by a predicate device's clinical study.

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

The document states: "A Clinical Study was performed using the Stereotaxis Telstar® MNS and Cronus® Guidewires to demonstrate the safety and efficacy of magnetically guided devices when used in the neurovasculature."

• Sample Size: The document does not specify the sample size used in this clinical study.
• Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective. It only states it was a "Clinical Study."

3. Number of Experts and Qualifications

The document makes no mention of experts used to establish ground truth for a test set, nor their qualifications. The study described is a clinical study on a predicate device demonstrating safety and efficacy in actual procedure, not an evaluation of diagnostic accuracy requiring expert interpretation of outputs.

4. Adjudication Method

The document does not describe any adjudication method. This is consistent with the nature of the study, which evaluated the safety and efficacy of a medical procedure/device rather than the interpretation of data/images.

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

No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned. The device in question (Niobe® MNS with Navigant™ NWS) is a steerable catheter control system for navigation, not a diagnostic imaging system that would typically involve human readers interpreting results with or without AI assistance.

6. Standalone (Algorithm Only) Performance

The concept of "standalone performance" (algorithm only performance without human-in-the-loop) is not applicable or discussed in this context. The Niobe® MNS with Navigant™ NWS is an interventional workstation that requires a human operator (interventional cardiologist/radiologist) to direct the navigation based on real-time imaging and clinical judgment. It does not operate as a standalone "algorithm" in the way a diagnostic AI might.

7. Type of Ground Truth Used

The "ground truth" for the clinical study referenced would have been clinical outcomes data related to the safety and efficacy of the procedure. This would include (but isn't explicitly detailed):

• Successful navigation to target sites.
• Absence of adverse events or complications.
• Achievement of the therapeutic goal for which the navigation was used.

This is inferred from the description "demonstrate the safety and efficacy of magnetically guided devices when used in the neurovasculature."

8. Sample Size for the Training Set

The document does not refer to a "training set" in the context of an AI/algorithm development. The "performance data" section refers to a clinical study of a predicate device, which would be an evaluation or validation study for that device, not a training set for an AI.

9. How Ground Truth for Training Set Was Established

As no training set (in the AI sense) is mentioned, there is no information on how its ground truth would have been established. The clinical study for the predicate device used real-world patient outcomes as its "truth" for evaluation.

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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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