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The CorPath 200 System is intended for use in the remote delivery and manipulation of guidewires and rapid exchange catheters during percutaneous vascular interventional (PVI) procedures.

The CorPath 200 System is intended for use by physicians in the delivery and manipulation of guidewires and rapid exchange catheters during percutaneous vascular interventional (PVI) procedures. The CorPath 200 System allows the physician to deliver and manipulate guidewires and catheters through the vasculature under angiography-assisted visual guidance using computer controlled movements while in a seated position and away from the radiation source.

The CorPath 200 System is composed of two functional sub-units; the Bedside Unit and the Remote Workspace. The Bedside Unit consists of the Articulated Arm, the Robotic Drive and the single-use Cassette. The Remote Workspace consists of the Interventional Cockpit (radiation shield) which houses the Control Console, as well as angiographic monitor(s). Commercially available guidewires and rapid exchange catheters are loaded into the single-use Cassette. By using the joysticks or touch screen of the Control Console, the physician can send commands to the Robotic Drive via a communication cable that advances, retracts or rotates the guidewire, and/or advances or retracts the catheters. The CorPath 200 System's software continuously monitors the communication between the Control Console and the Robotic Drive and alerts the physician if any communication error occurs.

Here's an analysis of the provided text, focusing on the acceptance criteria and study data for the CorPath 200 System:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in the form of pre-defined thresholds that the device needed to meet. Instead, it presents the reported performance directly from two clinical studies. However, based on the studies' objectives and reported outcomes, we can infer the implicit "acceptance criteria" related to safety and effectiveness.

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

• PRECISE Clinical Study (PCI):
  • Sample Size: 164 subjects.
  • Data Provenance: Prospective, multi-center, non-randomized study. The document does not explicitly state the country of origin, but "nine (9) clinical sites" typically implies a domestic (US) study for FDA submissions unless otherwise specified.
• RAPID Study (PVI):
  • Sample Size: 20 Rutherford Class 2 to 5 subjects (with 29 treated lesions).
  • Data Provenance: Prospective, non-randomized feasibility evaluation. The document does not explicitly state the country of origin.

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

• PRECISE Clinical Study (PCI):
  • Specifics of ground truth experts are not explicitly detailed. However, it mentions "post-procedure stenosis of less than 30% (as evaluated by a Core Laboratory)." A Core Laboratory implies a specialized facility with imaging experts (e.g., interventional cardiologists, radiologists) responsible for standardized, blinded evaluation of angiographic images. The number and specific qualifications (years of experience) are not provided.
• RAPID Study (PVI):
  • Specifics of ground truth experts are not explicitly detailed. Angiographic assessments (e.g., <50% residual stenosis) would typically be made by the interventional cardiologists or radiologists involved in the study, likely with independent verification, but this is not explicitly stated.

4. Adjudication Method for the Test Set

• PRECISE Clinical Study (PCI):
  • The document refers to a "Core Laboratory" for stenosis evaluation. Core laboratories typically employ adjudicated methods to ensure consistency and minimize bias, often involving multiple readers and consensus, but the specific adjudication method (e.g., 2+1, 3+1) is not explicitly mentioned.
• RAPID Study (PVI):
  • The document does not describe the adjudication method for the performance metrics.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improving with AI vs. Without AI Assistance

• No, an MRMC comparative effectiveness study, as typically understood for AI-assisted diagnostic devices, was explicitly described. The provided studies (PRECISE and RAPID) evaluated the robotic system's performance during the procedure, not as an AI diagnostic tool assisting human readers in interpreting medical images.
• The PRECISE trial did demonstrate "a reduction of radiation exposure to the primary operator," which is a beneficial effect related to using the robotic system, allowing the operator to be further from the radiation source. This is a safety benefit for the human operator, not an improvement in diagnostic accuracy or speed for human readers.

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

• No, a standalone algorithm performance study was not done because the CorPath 200 System is a robotic-assisted catheter control system designed for human-controlled manipulation during procedures, not a diagnostic AI algorithm. Its function is to execute the physician's commands remotely, not to provide independent analysis or decisions. The performance metrics reflect the combined performance of the system and the physician using it.

7. The Type of Ground Truth Used

• PRECISE Clinical Study (PCI):
  • Expert Consensus/Clinical Outcomes: This includes evaluation by a "Core Laboratory" for angiographic stenosis, and clinical endpoints like Major Adverse Cardiac Events (MACE) and overall procedural success. MACE is an important clinical outcome.
• RAPID Study (PVI):
  • Clinical Outcomes/Procedural Success: This includes successful cannulation, <50% residual stenosis, absence of device-related SAEs, and absence of angiographic complications, all as determined by clinical assessment during and after the procedure.

8. The Sample Size for the Training Set

• Not Applicable / Not Provided. The CorPath 200 System, as described, is a robotic control system for physical manipulation of medical devices, not an AI/machine learning algorithm that requires a training set in the conventional sense. Its "software continuously monitors the communication," but this refers to operational control, not a learning algorithm that processes data to improve its diagnostic or predictive capability. Therefore, there is no mention of a "training set" for the device's core functionality.

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

• Not Applicable / Not Provided. As there is no described training set for an AI algorithm, the method for establishing its ground truth is not relevant to this device's description.

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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 (< 0.056" OD). There are no new materials or colorants used in the design of the Microcatheter Driver components. The main body of the catheter and the splayer remain unchanged. The optional proprietary non-articulating MRC 6Fr Leader (4.2 Fr OD x 3 Fr ID) is also available for use with the MRC eKit. The MRC 6Fr & eKit Leader is the same MRC 6Fr Leader cleared under K515463; only now it will be packaged with a Support Tube for use with the microcatheter driver.

Identical to the MRC 6Fr, the MRC eKit is provided sterile and is intended for single use only. The eKit is one of several compatible devices available for use with Hansen Medical's Magellan Robotic System (cleared under K111004, K132369, K141614, and K151730).

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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