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The Hansen Medical Vascular Catheter Control System, Hansen Catheter and accessory components are intended to be used to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices.

The Hansen Medical Magellan Robotic System and NorthStar Robotic Catheter and Accessory Components are designed to facilitate remote navigation to anatomical targets in the peripheral vasculature. Subsequent to navigation, the system provides a conduit for manual placement of therapeutic devices. The Magellan Robotic System's operating principles are similar to those of the Sensei X Robotic Catheter System. The fundamental concept of the robotic system is based on a master/slave control system that enables and visualizes positioning of a steerable catheter tip at a desired point inside the vasculature, while enabling a physician to remain seated and away from the x-ray radiation source.

Here's a breakdown of the acceptance criteria and study information for the Hansen Medical Magellan™ Robotic System, NorthStar™ Robotic Catheter, and Accessory Components, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state numerical acceptance criteria in a table format with corresponding performance results. However, it describes the types of tests conducted and concludes that the device successfully met established specifications and did not raise new questions of safety or effectiveness.

Therefore, the table below reflects what was stated as satisfactorily completed or demonstrated success rather than explicit numerical acceptance criteria.

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

The clinical study involved:

• Sample Size: 20 procedures (15 enrolled subjects).
• Data Provenance: The study was a "prospective, single center" study. The country of origin is not explicitly stated, but given the applicant's US address and the FDA submission, it is highly likely to be a US-based study. It was prospective.

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

The provided text describes a clinical study focused on the device's performance in navigating and delivering therapeutic devices rather than an image-based diagnostic task requiring ground truth established by experts interpreting images. Therefore, this information is not applicable in the context of the provided text. The "ground truth" for the clinical study was the actual successful cannulation of vessels and completion of procedures, along with safety outcomes.

4. Adjudication Method for the Test Set

As this was a performance study of a robotic system in a clinical setting (not an image interpretation study), an "adjudication method" in the sense of reconciling differing expert opinions on a diagnosis is not applicable. The primary outcome measures (successful cannulation, completion of angiography, navigation to lesion, absence of adverse events) would have been observed and recorded by the operating physicians and study staff according to the study protocol.

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

There was no MRMC comparative effectiveness study described in the provided text. The clinical study was a single-arm study evaluating the device's performance, not comparing human readers with and without AI assistance.

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

The provided text describes the device as a "master/slave control system" where the physician inputs commands to control the robotic catheter. This inherently describes a human-in-the-loop system. Therefore, a standalone (algorithm only) performance, in the sense of a fully autonomous AI system making decisions without human input, was not performed nor is it relevant to this device's intended use or design.

7. The Type of Ground Truth Used

• Bench/Preclinical Testing: Engineering specifications, ISO standards, and established biological/material science outcomes (e.g., successful visual verification, tensile strength values, biocompatibility panel results, sterility levels, tracking pathways in simulated anatomy).
• Animal Studies: Observed in-vivo functionality, performance against system design requirements, comparison of vascular injury rates (fewer and less severe injuries compared to manual control).
• Clinical Study: Direct observation of successful robotic navigation (cannulation, guidance to target), successful completion of angiography, absence of device-related adverse events, and ultrasound confirmation of no access site complications. This is essentially outcomes data and direct procedural success.

8. The Sample Size for the Training Set

The provided text describes the Magellan Robotic System as having operating principles "nearly identical" to the predicate Sensei X Robotic Catheter System (K102168). It is a robotic control system for a catheter, not a machine learning or AI algorithm that requires a "training set" in the conventional sense used for diagnostic imaging AI. Therefore, the concept of a "training set" with a specific sample size for a machine learning model is not applicable to this device as described. The system's "training" would have been through engineering design, software development, and iterative testing/refinement.

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

As explained above, the concept of a "training set" for a machine learning model is not applicable here. The "ground truth" for the development of such a robotic system would be its adherence to engineering specifications, safety standards, and functional requirements established through design, simulation, and rigorous testing against known physical and mechanical principles.

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