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The Hansen Medical Magellan Robotic System 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 Magellan Robotic System is intended to be used with compatible Hansen Medical robotically steerable catheters.

The Hansen Medical Magellan Robotic System and Accessory Components are designed to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices. The fundamental concept of the 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. The modification to the Magellan Robotic System is software update referred to as Magellan v1.9.1.

This document is a 510(k) premarket notification for the Hansen Medical Magellan Robotic System and Accessory Components (K151730). It primarily details a software update (Magellan v1.9.1) to an already cleared device (K141614). The core argument for substantial equivalence relies on the fact that the modifications do not change the intended use, fundamental scientific technology, or operating principles.

As such, this submission does not describe a study to prove a device meets acceptance criteria in the way a new or significantly modified device submission might. Instead, it aims to demonstrate that a software update to an existing device does not degrade performance and maintains substantial equivalence.

Therefore, many of the requested elements (like sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance details, training set size, etc.) are not applicable or not provided in this type of submission because the focus is on maintaining existing safety and effectiveness rather than establishing new performance benchmarks.

However, I can extract information related to the acceptance criteria and the study type that was mentioned:

1. Table of acceptance criteria and the reported device performance

Important Note: The document states that "All of the pre-determined acceptance criteria were met," but it does not explicitly list what those specific acceptance criteria were (e.g., specific thresholds for accuracy, reliability, or safety metrics). The document focuses on confirming that the updated software did not introduce new risks or deviations from the predicate device's expected performance.

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

• Sample Size: Not specified.
• Data Provenance: Not specified. Given the nature of software verification and system validation, these would typically be internal laboratory tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable/Not specified. This type of information is typically relevant for clinical studies or studies involving human interpretation of data, which was not the focus here. The performance was assessed through engineering and system-level tests.

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

• Not applicable/Not specified. Adjudication methods are typically used in clinical trials where multiple human readers assess cases, which is not the case for this software update 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

• No. An MRMC comparative effectiveness study was not done. This submission concerns a software update to a robotic navigation system, not an AI-assisted diagnostic tool for human readers.

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

• Yes, in a sense. The "Software Verification Testing" and "System Validation Testing" represent standalone evaluations of the updated software and system to confirm they perform as expected without human intervention impacting the robotic movement or calculations directly. However, the performance is evaluated against the system's designed specifications, not necessarily an "algorithm only" in the AI sense.

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

• For "Software Verification Testing" and "System Validation Testing," the ground truth would be based on the design specifications, functional requirements, and safety standards established for the device. For example, a navigation system's ground truth could be its ability to accurately move the catheter to a programmed position within a defined tolerance. It does not involve medical ground truth like pathology or expert consensus on a diagnosis.

8. The sample size for the training set

• Not applicable/Not specified. This document pertains to a software update to an existing robotic control system, not a machine learning or AI model that uses a training set in the conventional sense.

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

• Not applicable. (See #8)

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The Hansen Medical Magellan Robotic System 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 Magellan Robotic System is intended to be used with compatible Hansen Medical robotically steerable catheters.

The Hansen Medical Magellan Robotic System and accessory components are designed to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices. The fundamental concept of the 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. The modification adds a mechanical joint between the Magellan Robotic System Rail and Adapter Plate to facilitate removal.

The Magellan Robotic System and accessory components are compatible with Hansen Medical robotically steerable catheters approved under previous 510(k)s.

This document describes a 510(k) premarket notification for the Hansen Medical Magellan Robotic System, which is a steerable catheter control system. The submission is for a modification to an already cleared device (K132369).

Here's the breakdown of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not detail specific sample sizes for the visual, dimensional, IEC, table compatibility, or life cycle testing. It simply states that testing was performed and all pre-determined acceptance criteria were met. The data provenance is not explicitly mentioned (e.g., country of origin or retrospective/prospective). Given that the testing categories are related to engineering and regulatory standards, it's highly likely this was internal, prospective testing performed by the manufacturer or a contracted lab.

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

Not applicable. The testing described (visual, dimensional, IEC, table compatibility, life cycle) are engineering and technical verification tests, not clinical performance tests requiring expert ground truth establishment for a test set in the traditional sense of AI/clinical studies.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human readers or clinical adjudication. The acceptance criteria were met based on the results of the specified engineering and technical tests.

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 performed or described. This submission is for a robotic system for facilitating navigation in the peripheral vasculature, not an AI-assisted diagnostic or interpretative device that would typically involve human readers. The document explicitly states: "No additional clinical evaluation of the Magellan Robotic System is required as a result of these changes."

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

This is not directly applicable in the context of an algorithm's standalone performance for diagnostic or interpretive tasks. The "device" itself (the Magellan Robotic System) operates in a master/slave control system with a physician-in-the-loop for navigation. The testing performed was "Design verification testing," which focuses on the device's technical specifications and adherence to standards rather than an algorithm's standalone clinical accuracy.

7. The Type of Ground Truth Used

The "ground truth" for the engineering and technical tests would be the established specifications, standards (e.g., IEC 606061-1), and design requirements for the device. For example, for dimensional verification, the ground truth would be the engineering drawings and specified tolerances. For IEC testing, the ground truth would be the pass/fail criteria defined by the standard.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML product developed using a training set in the typical sense. It is a robotic system with physical and operational characteristics verified through engineering tests.

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

Not applicable, as there is no training set for this type of device and submission.

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Magellan Robotic System: The Hansen Medical Magellan Robotic System 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 Magellan Robotic System is intended to be used with compatible Hansen Medical robotically steerable catheters.

Magellan Robotic Catheter 9Fr. The Hansen Medical Magellan Robotic Catheter 9Fr 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 9Fr is intended to be used with the Hansen Medical Magellan Robotic System and accessories.

The Hansen Medical Magellan Robotic System and Magellan Robotic Catheter 9Fr and Accessory Components are designed to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices. The fundamental concept of the 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. The modifications to the Magellan System were made to expand system-quide wire compatibility, provide alternate quide wire navigation using the Master Input Device in addition to the existing Workstation and Bedside Controllers and to provide support for future compatible Hansen vascular catheters.

This document describes a Special 510(k) submission for modifications to the Hansen Medical Magellan Robotic System and Magellan Robotic Catheter 9Fr. This type of submission focuses on demonstrating that the modified device remains substantially equivalent to the previously cleared predicate device, rather than proving new clinical effectiveness. Therefore, the information typically associated with studies proving device performance against acceptance criteria (like sample sizes, ground truth establishment, or clinical effectiveness studies) is largely absent or stated as not required.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list quantitative acceptance criteria in a table format with specific performance metrics (e.g., sensitivity, specificity, accuracy) for an AI/algorithm-based device. This is because the submission is for a robotic catheter system, not an AI diagnostic tool.

Instead, the "acceptance criteria" are implied by the comprehensive design verification and validation testing performed to ensure the modified system continues to meet design specifications and customer requirements. The reported device performance is that it successfully passed these tests and was found to be substantially equivalent to the predicate device.

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

The document does not specify a "test set" in the context of an AI algorithm with data samples. The testing described is verification and validation of a physical/software system. Therefore, details like country of origin or retrospective/prospective data are not applicable. The testing would involve a combination of simulated scenarios, bench testing, and potentially animal/cadaveric studies (though not detailed here for this specific submission).

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

This information is not applicable. The "ground truth" for a robotic catheter system's performance is typically established through engineering specifications, regulatory standards, and objective measurements during verification and validation testing, not through expert consensus on medical images or diagnoses.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods are relevant for studies involving human interpretation or subjective assessments, which is not the primary focus of this submission for a robotic system.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC study was done, nor would it typically be expected for this type of device modification submission. The device is a robotic system to facilitate navigation, not a diagnostic tool that humans would use to interpret cases. The focus is on the functional equivalence of the system, not on comparing human reading performance with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This is not applicable. The Magellan system is a master/slave control system, inherently designed for human-in-the-loop operation. It is not an autonomous algorithm operating without human intervention for diagnostic or treatment decisions.

7. The Type of Ground Truth Used

The "ground truth" for the verification and validation tests performed for this robotic system would be based on:

• Engineering Specifications: Whether the system performs according to its design parameters (e.g., catheter tip movement, guide wire compatibility).
• Customer Requirements: Whether the system meets the functional needs for which it was designed.
• Regulatory Standards: Compliance with relevant standards like electrical safety (implied by "Electrical Safety Test") and risk management (ISO 14971).
• Performance against Predicate Device: Demonstration of substantial equivalence in intended use, technological characteristics, and safety/effectiveness.

8. The Sample Size for the Training Set

This is not applicable. The Magellan system is not an AI/machine learning model in the sense of requiring a "training set" of data samples. Its software modifications relate to system functionality, user interface, and compatibility, not learning from a dataset.

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

This is not applicable, as there is no "training set." The software modifications were likely developed and tested against established engineering requirements and functional specifications based on the device's intended use and the predicate device's performance.

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