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The Hansen Medical Magellan™ Robotic Catheter 9Fr is intended 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 Long Length (80 cm) is also indicated for use as a conduit for manual placement of therapeutic devices in the neuro vasculature.

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

The proposed change to the Hansen Medical Magellan™ Robotic Catheter (MRC) 9Fr is to the Indications for Use only; there is no change to the fit, form, or function of the device or to any of its components and accessories cleared under K132369.

The MRC 9Fr is a telescoping design comprised of a steerable Leader within a steerable Guide and is designed to be used with the Hansen Medical Magellan™ Robotic System (Magellan System). The distal sections of each Hansen Catheter component articulate individually and the distal end of the Leader can extend up to 21cm beyond the distal end of the Guide.

The Leader is a tubular catheter with four pull wires articulating the distal 3cm. The Leader has a 6Fr outer diameter and 3Fr inner diameter, and is available in 125cm, 141cm, and 158cm lengths. The Leader fits inside the Guide and is only used in conjunction with the Guide. The distal end of the Leader has a 3cm flexible articulating section. The Leader has a radiopaque marker band between the articulating section and the atraumatic tip. The tip extends 4mm distal to the marker band.

The Guide is a tubular catheter with four pull wires articulating the distal 2.8cm. The Guide has a 6Fr inner diameter and 9Fr outer diameter. The Guide is available in 50cm, 65cm, or 80cm lengths. The Guide fits around the Leader and may be used with or without the Leader. When the Leader is removed from the Guide, a 6Fr compatible percutaneous catheter may be delivered through the Guide.

The Hansen Catheter family consists of three different lengths of Leader and Guide pairs, and all sizes are sterilized via EtO for single use only. However, the MRC 9Fr Short (50cm) and MRC 9Fr Medium (65cm) catheters are not included for the expanded indication as they are not long enough to access the target anatomy.

This document is a 510(k) premarket notification for the Hansen Medical Magellan Robotic Catheter 9Fr, which is intended to facilitate navigation to anatomical targets and provide a conduit for therapeutic devices. The submission focuses on expanding the indications for use of the 80cm long version of the catheter to include neurovasculature.

Here's an analysis of the provided text with respect to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of a numerically defined threshold for performance for a new AI/medical device. Instead, it relies on demonstrating substantial equivalence to a predicate device. This is a common approach for Class II medical devices seeking 510(k) clearance in the US. The "performance" assessment is a comparison of technological characteristics and intended use.

Here's a table based on the "Performance Attribute and Characteristic Comparison" table (on page 8) for the expanded indication compared to the predicate device:

Reported Device Performance (against the predicate): The document states: "The minor differences in the characteristics between the two products do not alter the performance and do not present any new issues of safety or effectiveness." It concludes that the device "is substantially equivalent with respect to intended use and technological characteristics as the predicate device, and is expected to perform equivalently in accessing the neuro vasculature." The "performance" is demonstrated through design validation and verification activities described in Section 18.0 Performance Testing (which is not included in the provided text but is referenced).

2. Sample size used for the test set and the data provenance

The document explicitly states: "Clinical evaluation is not required for this device." Therefore, there is no "test set" in the sense of patient data for clinical evaluation, nor is there information on sample size or data provenance for such a test. The evaluation relies on comparing technological characteristics and performance data from internal design validation and verification.

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

Not applicable, as no clinical test set was required or used.

4. Adjudication method for the test set

Not applicable, as no clinical test set was required or used.

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

Not applicable. This is a robotic steerable catheter, not an AI-assisted diagnostic or interpretative device that augments human readers.

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

Not applicable. This is a physical robotic catheter, not a standalone algorithm.

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

The document does not detail specific "ground truth" as would be used in an AI or diagnostic imaging study. Instead, the "truth" for this device's performance relies on engineering and performance testing data (referenced as "design validation and verification activities described in Section 18.0 Performance Testing" on page 7) to ensure physical characteristics (dimensions, flexibility, guidewire compatibility, etc.) meet specifications and are comparable to the predicate device for the intended use in neurovasculature.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. This is not an AI/machine learning device that requires a training set.

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

The Hansen Medical Magellan™ Robotic Catheter eKit (MRC eKit) incorporates Microcatheter Driver components to be used in conjunction with the Magellan Robotic Catheter 6Fr (MRC 6Fr ) cleared under K515463. Both the predicate device (MRC 6Fr) and the MRC eKit are comprised of a Guide (Outer Catheter) with dual bend articulating sections (distal and proximal) paired with a non-articulating Leader. The devices are both provided in two lengths (60cm and 95cm) and have been designed to be used with Hansen Medical Magellan Robotic System. Both the MRC 6Fr and the MRC eKit are intended to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices.

The MRC eKit is comprised of the Hansen Medical 6Fr Guide catheter that is found in the commercialized product MRC 6Fr, and Microcatheter Driver components. The Microcatheter Driver components include a Microcatheter Support, a Microcatheter Driver base, a Connector Tube, a Support Tube packaged with and for use with the Leader, and a Microcatheter Valve. These components function the same as the Wire Support in the MRC 6Fr device to robotically insert and retract the Leader. Modifications have been made to now allow for robotic insertion and retraction of third-party inner catheters / microcatheters compatible with 5F Guiding catheters (

Here's an analysis of the provided text regarding the acceptance criteria and study for the Hansen Medical Magellan Robotic Catheter eKit:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The document states that "All of the pre-determined acceptance criteria were met," but it does not explicitly list the specific numerical or qualitative acceptance criteria for each test. This is a significant gap in the provided information.

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

The document does not specify the sample sizes used for any of the tests (Dimensional Analysis, Burst Pressure Testing, Joint Separation Force Testing, Simulated Use Testing).

The data provenance is from in-house design verification testing conducted by Hansen Medical, Inc. based in Mountain View, CA, USA. The studies appear to be prospective as they were conducted as part of the device's design verification.

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

This information is not applicable to the type of testing performed. The studies described are engineering/mechanical and functional performance tests of a medical device, not clinical studies requiring expert ground truth for interpretation of medical data (e.g., image analysis, diagnosis). The "ground truth" here is the adherence to design specifications and mechanical performance standards, which would be assessed by engineers and quality control personnel.

4. Adjudication Method for the Test Set

This information is not applicable as the described tests are objective measurements of physical properties and functional operation, rather than subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The provided text indicates that "Clinical evaluation is not required for this device." The studies focused on confirming the device's physical and functional performance against pre-determined criteria.

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

This question is not applicable as the device is a physical robotic surgical catheter, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the tests performed was based on engineering design specifications and performance standards. For example, burst pressure would be measured against a specified maximum pressure tolerance dictated by the design. Similarly, joint separation force would need to meet a minimum threshold. The "reliability of inserting and retracting a third party microcatheter" in simulated use testing would be assessed against a defined successful operation criterion.

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical medical instrument, not an AI model that requires a training set.

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

This question is not applicable as there is no training set for this device.

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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 v1.2 and accessories are a modification of the predicate Magellan Robotic Catheter 6Fr (MRC 6Fr) and accessories cleared under K133552. Both the predicate device and the modified Magellan Robotic Catheter 6Fr are comprised of a Guide (Outer Catheter) with dual bend articulating sections (distal and proximal) paired with a nonarticulating Leader (Inner Catheter). The devices are provided in two lengths (60cm and 95cm). Like the predicate device, the MRC 6Fr v1.2 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. Both the MRC 6Fr v1.2 and the predicate may also be used for delivery of diagnostic contrast agents. The modified MRC 6Fr is compatible with power contrast injection systems up to a maximum of 600 psi. Whereas, the predicate device is rated for a maximum pressure of 100 psi. The device is provided sterile and is intended for single use only. The catheter is one of several compatible devices available for use with Hansen Medical's Magellan Robotic System cleared under K111004, K132369 and K141614.

This document, an FDA 510(k) summary for the Hansen Medical Magellan Robotic Catheter 6Fr v1.2, is a premarket notification for a medical device. It focuses on demonstrating "substantial equivalence" to a previously cleared predicate device, rather than proving performance against specific acceptance criteria for a novel AI device or diagnostic. Therefore, the information required to answer your specific questions about acceptance criteria, a study proving the device meets those criteria, and details about a test set, expert involvement, and ground truth is largely not present in this document.

The document mainly describes modifications to an existing device (increased pressure rating for contrast injection) and uses design verification testing to show that the performance remains substantially equivalent to the predicate device.

However, I can extract the following information that is tangentially related or directly stated:

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

The document states:

• "All of the pre-determined acceptance criteria were met."
• "Testing performed on the Magellan Robotic Catheter 6Fr v1.2 included the following:
  • Tensile Strength Testing
  • Simulated Use Testing
  • Pressure Burst Testing
  • ISO MEM Elution Cytotoxicity Testing
  • ASTM Hemolysis
  • Chemical Characterization Testing"

However, the specific numerical or qualitative acceptance criteria themselves and the reported device performance values are NOT detailed in this public summary. This level of detail would typically be found in the full test reports submitted to the FDA, not in the summary document.

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

• Sample size: Not specified. The document only mentions "testing" and "design verification testing."
• Data provenance: Not specified, but given it's a 510(k) for a US market device, the testing would typically be conducted under US regulatory standards. It's pre-market testing, so it's inherently prospective for the device modifications being assessed.

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)

• Not applicable / Not specified. This type of information relates to clinical studies, particularly for diagnostic devices or AI, which is not the focus of this 510(k) given its scope is modification of a previously cleared Class II catheter. The document explicitly states: "Clinical evaluation is not required for this device."

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

• Not applicable / Not specified. See point 3.

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. This is not an AI device or a diagnostic device. It's a robotic catheter used for navigation and delivery of therapeutic devices. MRMC studies are not relevant here.

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

• Not applicable. This is a physical medical device (catheter) used with a robotic system, not a standalone algorithm.

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

• For the engineering tests conducted (Tensile Strength, Pressure Burst, etc.), the "ground truth" would be the engineering specifications and validated test methods. For example, a pressure burst test would have a defined pass/fail pressure, which is the ground truth. There is no expert consensus, pathology, or outcomes data used as "ground truth" for these types of mechanical and material tests.

8. The sample size for the training set

• Not applicable. This isn't an AI/machine learning device that requires a training set.

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

• Not applicable. This isn't an AI/machine learning device.

In summary: This document is a regulatory submission for a minor modification to an existing robotic catheter. It confirms that the modified device remains substantially equivalent to its predicate. The proof of meeting acceptance criteria lies in standard engineering and material compatibility testing, not in clinical studies involving human interpretation or AI performance that would require the detailed information you are seeking.

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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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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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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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The Hansen Medical Sensel® X Robotic Catheter System and Accessories are intended to facilitate manipulation, positioning and control of Hansen Medical's robotically steerable catheters for collecting electrophysiological data within the heart atria with electro-anatomic mapping and recording systems, using the following percutaneous mapping catheters: the Polaris-Dx™ Steerable Diagnostic catheters made by Boston Scientific Corporation and the Livewire™ Electrophysiology catheters made by St. Jude Medical.

The Hansen Medical Sensei X Robotic Catheter System and Accessories, when used in conjunction with compatible Hansen Control Catheters, are designed to facilitate manipulation, positioning and control of mapping percutaneous catheters within the atria of the heart. 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 heart, while enabling a physician to remain seated and away from the x-ray radiation source. The modifications to the Sensei X Robotic Catheter System include an enhancement to the motion scaling feature.

The provided document is a 510(k) summary for the Hansen Medical Sensei® X Robotic Catheter System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a performance study in the way one would expect for a new, non-substantially equivalent device.

Therefore, the requested information regarding acceptance criteria, specific performance metrics, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies is not present in this 510(k) summary.

Key takeaways from the document:

• Device: Hansen Medical Sensei® X Robotic Catheter System.
• Purpose: To facilitate manipulation, positioning and control of robotically steerable catheters for collecting electrophysiological data within the heart atria.
• Modification: An enhancement to the motion scaling feature.
• Predicate Device: Earlier Sensei System (K091808).
• Basis for Approval: Substantial equivalence, meaning the modified device performs as safely and effectively as the previously cleared (predicate) device, and the modifications do not affect its intended use or fundamental scientific technology.

Since the submission is a "Special 510(k)" for a modification, the focus is on demonstrating that the change does not raise new safety or effectiveness concerns, rather than conducting a full performance study as if it were a novel device. The FDA typically relies on the established safety and effectiveness of the predicate device.

To directly answer your questions based only on the provided text, many fields will be "Not Reported" or "Not Applicable" for this type of submission:

1. Table of acceptance criteria and the reported device performance

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

• Sample Size (Test Set): Not reported.
• Data Provenance: Not reported. (For a Special 510(k) focusing on a modification, often internal verification and validation data are used rather than clinical studies in the traditional sense, but the specifics are not disclosed here.)

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

• Not applicable/Not reported. This type of performance study for ground truth establishment is typically not part of a Special 510(k) submission for a device modification.

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

• Not applicable/Not reported.

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

• Not applicable. This device is a robotic catheter system, not an AI-assisted diagnostic tool. No human reader study is mentioned.

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

• Not applicable. This is a robotic system, not a standalone algorithm. The performance evaluation focuses on the safety and functionality of the robotic system itself and its interaction with compatible catheters, implicitly with a human operator.

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

• Not applicable/Not reported. The submission focuses on demonstrating substantial equivalence, often through engineering and functional testing rather than direct clinical ground truth comparison in the context of diagnostic accuracy.

8. The sample size for the training set

• Not applicable/Not reported. (This is not an AI/machine learning device that would have a "training set" in that context.)

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

• Not applicable/Not reported.

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The Hansen Medical Sensei® Robotic Catheter System and Accessories are Intended to facilitate manipulation, positioning and control of Hansen Medical's robotically Steerable electrophysiological catheters for collecting electro-anatomic mapping and recording data within the heart atria with collecting mapping catheters: the Polarissystems, using the following percutaneous catheters made by Boston Scientific Corporation DX™ Steerable Diagnostic catheters made by St. Jude Medical.

The Hansen Medical Sensei Robotic Catheter System and Accessories, when used with compatible Control Catheters, are designed to facilitate manipulation, positioning and control of mapping percutaneous catheters within the atria of the heart. The fundamental concept of the system is based on a master-slave control system that enables and visualizes catheter tip at a desired point inside the heart, while enabling a physician to remain seated and away from the x-ray radiation source. The modifications to the Sensei Robotic Catheter System include the ability to import electroanotomic maps from a 3D party mapping system.

This 510(k) submission (K091808) for the Hansen Medical Sensei Robotic Catheter System does not contain a study that provides acceptance criteria and reported device performance in the way typically expected for a performance study evaluating diagnostic or therapeutic efficacy.

Instead, this is a Special 510(k) Submission for a modification to an already cleared device (K090365). The documentation focuses on demonstrating substantial equivalence to the predicate device, not on presenting new performance data against specific acceptance criteria. This type of submission would typically involve engineering analysis, bench testing, and sometimes limited animal or human use data to show that the modifications do not negatively impact safety or effectiveness or alter the fundamental scientific technology.

Therefore, the specific information requested cannot be fully extracted from the provided text, as the document does not describe a clinical performance study with acceptance criteria and results.

However, I can extract information related to the device's predicate, intended use, and the FDA's decision, which are relevant to its acceptance.

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, a formal table of acceptance criteria and reported device performance in the context of a validation study is not provided in this Special 510(k) summary. This type of submission relies on demonstrating that the modified device is substantially equivalent to a previously cleared device (K090365) and that the modifications do not raise new questions of safety or effectiveness.

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

This information is not provided as there is no described clinical performance study with a 'test set' in the context of efficacy or diagnostic accuracy. The submission focuses on substantial equivalence based on prior clearance and potentially engineering testing for the modifications.

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

This information is not provided as there is no described clinical performance study requiring expert ground truth establishment for a test set.

4. Adjudication Method for the Test Set

This information is not provided as there is no described clinical performance study requiring adjudication for a test set.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size

An MRMC comparative effectiveness study is not mentioned or described in the provided documents.

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

A standalone algorithm performance study is not mentioned or described in the provided documents. The device is a "Robotic Catheter System" designed for physician control and manipulation of catheters.

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

This information is not provided as there is no described clinical performance study requiring ground truth.

8. The Sample Size for the Training Set

This information is not provided as there is no described algorithm training set.

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

This information is not provided as there is no described algorithm training set or ground truth establishment for it.

Summary of FDA's "Acceptance" (Substantial Equivalence Determination):

• Predicate Device: The modified Hansen Medical Sensei Robotic Catheter System (K091808) is deemed substantially equivalent to the earlier Sensei System (K090365).
• Basis for Equivalence: The modifications described "do not significantly affect the safety or effectiveness of the device or alter the fundamental scientific technology associated with the device."
• Intended Use: The modified device has the same intended use as the predicate: "to facilitate manipulation, positioning and control of Hansen Medical's robotically Steerable Electrophysiological Control Catheters of Hansen Medical or to facilitate manipulation, positioning and control of mapping percutaneous catheters within the atria of the heart to acquire electro-anatomic mapping and recording data within the heart atria with our existing mapping catheters: the Polaris X™ Steerable Diagnostic catheters made by Boston Scientific Corporation, and the DX-S™ Steerable Diagnostic catheters made by St. Jude Medical."
• FDA Limitation/Warning: The FDA imposed a critical labeling limitation: "The safety and effectiveness of this device for use with cardiac ablation catheters, in the treatment of cardiac arrhythmias including atrial fibrillation, have not been established." This warning must be prominently displayed on the device, packaging, and all promotional materials. This indicates a specific aspect where the device's performance (for ablation) was not accepted without further evidence.

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The Hansen Medical Artisan S Control Catheter is intended to facilitate manipulation, positioning and control, for collecting electrophysiological data within the heart atria with electro-anatomic mapping and recording systems, using the following percutaneous mapping catheters: the Polaris-Dx™ Steerable Diagnostic catheters made by Boston Scientific Corporation and the Livewire™ Electrophysiology catheters made by St. Jude Medical.

The Control Catheter is intended to be used with the Hansen Medical Sensei® Robotic Catheter System.

The Hansen Medical Artisan S Control Catheter is designed to facilitate manipulation, positioning and control of mapping percutaneous catheters within the atria of the heart. The Control Catheter consists of an Inner Guide and an Outer Guide Catheter. The Control Catheter is designed to be used with the Hansen Medical Sensei® Robotic Catheter System.

The provided text is a 510(k) summary for the Hansen Medical Artisan S Control Catheter. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria, device performance testing, study design, sample sizes, ground truth establishment, or expert involvement, as these are typically detailed in the full 510(k) submission, not the public summary.

Therefore, I cannot fulfill your request for specific details about the acceptance criteria and the study that proves the device meets them based solely on the provided text.

The document states:

• Device Information: Hansen Medical Artisan S Control Catheter
• Intended Use: To facilitate manipulation, positioning, and control for collecting electrophysiological data within the heart atria with electro-anatomic mapping and recording systems, using specific percutaneous mapping catheters (Polaris-Dx™ and Livewire™). Intended for use with the Hansen Medical Sensei® Robotic Catheter System.
• Predicate Device: Hansen Medical Steerable Guide Catheter (SGC) and Sheath ("Artisan Control Catheter") (K073225).
• Comparison to Predicate: The Artisan S Control Catheter is a "minor modification" to the predicate, with modifications not affecting intended use or fundamental scientific technology.
• Substantial Equivalence: Based on indications for use and "design and engineering data provided in this pre-market notification," it has been shown to be substantially equivalent.

Key Missing Information (which would be in the full 510(k) submission, but not in this summary):

• Acceptance Criteria Table: No specific performance metrics or acceptance criteria are listed.
• Reported Device Performance: No test results or performance data are provided.
• Sample Sizes/Data Provenance for Test Set: Not mentioned.
• Number of Experts/Qualifications for Ground Truth: Not applicable as no specific test data or ground truth seems to be discussed in the summary.
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: No mention of such a study.
• Standalone Performance: Not explicitly stated, but the summary focuses on comparing it to a predicate rather than detailed performance numbers.
• Type of Ground Truth: Not mentioned.
• Training Set Sample Size/Ground Truth Establishment for Training Set: Not applicable as this is not an AI/machine learning device; it's a medical device (catheter). The concept of "training set" is not relevant here.

The document indicates that the substantial equivalence was based on "design and engineering data," which would include bench testing, biocompatibility, sterilization validation, etc., but these details are not provided in this 510(k) summary. The FDA's letter (K090365 page 2/2) confirms the substantial equivalence determination and establishes a labeling limitation regarding its use with cardiac ablation catheters for treating arrhythmias. This limitation suggests that efficacy for these specific applications was not established.

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