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The Hansen Medical Magellan Robotic Catheter 6Fr is 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 Magellan Robotic Catheter 6Fr is intended to be used with the Hansen Medical Magellan Robotic System and accessories.

The Magellan Robotic Catheter 6Fr (MRC 6Fr) and accessories are a modification of the predicate Magellan Robotic Catheter 9Fr (MRC 9Fr) and accessories cleared under K132369. The Magellan Robotic Catheter 6Fr is a smaller size catheter comprised of a Guide (Outer Catheter) with dual bend articulating sections (distal and proximal) paired with a non-articulating Leader (Inner Catheter). The device is provided in two lengths (60cm and 95cm). Like the predicate device, the MRC 6Fr is designed to be used with Hansen Medical Magellan Robotic System and is intended to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices. The MRC 6Fr may also be used for delivery of diagnostic contrast agents. The device is provided sterile and is intended for single use only. The catheter is designed to expand Hansen Medical's market offering of compatible devices available for use with the Magellan Robotic System cleared under K132369.

The provided text describes a 510(k) summary for the Hansen Medical Magellan Robotic Catheter 6Fr. It is a submission for a modified device, primarily focusing on its substantial equivalence to a predicate device (Magellan Robotic Catheter 9Fr).

Therefore, the acceptance criteria and study information pertain to demonstrating this substantial equivalence through non-clinical testing.

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

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

The document states: "All of the pre-determined acceptance criteria were met." However, it does not explicitly list the quantitative acceptance criteria for each test or the specific numerical performance results. It only lists the types of tests performed.

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

The document does not specify the sample sizes used for any of the non-clinical tests. It also does not provide information on the country of origin of the data or whether the data was retrospective or prospective. Given these are non-clinical (bench and lab) tests, these details are typically less relevant than for clinical studies.

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)

This information is not applicable and not provided. The study performed consists of non-clinical, benchtop and lab-based engineering, and biocompatibility tests, not clinical studies requiring expert ground truth for interpretation.

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

This information is not applicable and not provided. As noted above, the study involved non-clinical tests, which do not typically involve adjudication methods for "ground truth" in the way clinical diagnostic image interpretation studies would. The "ground truth" for these tests would be the established scientific and engineering standards and methods.

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

No MRMC comparative effectiveness study was done. The document explicitly states: "Clinical evaluation is not required for this device." This is a submission for a modified steerable catheter, demonstrating substantial equivalence through non-clinical testing.

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

This information is not applicable. The device is a robotic catheter, not an algorithm or AI system for diagnostic interpretation that would have "standalone" performance in the context of diagnostic accuracy. The performance testing described is for the physical and biological characteristics of the catheter itself.

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

The "ground truth" for the non-clinical tests described would be the established scientific and engineering principles, specifications, and regulatory standards to which the device was tested. For example, for biocompatibility, the ground truth is defined by ISO 10993-1, and for physical tests, it's defined by engineering specifications and industry standards for catheter performance (e.g., specific thresholds for tensile strength, leak rates, articulation angles, etc.). These are not "expert consensus" or "pathology" in the diagnostic sense.

8. The sample size for the training set

This information is not applicable and not provided. This device is a physical medical device (catheter) and not an AI/ML algorithm that requires a "training set."

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

This information is not applicable and not provided for the same reasons as point 8.

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