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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.

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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 Medrobotics Flex® System is a device that is intended for robot-assisted visualization and surgical site access to the oropharynx, hypopharynx, and larynx in adults (≥ 22 years of age). The Flex System also provides accessory channels for compatible flexible instruments used in surgery.

The Flex System is an operator-controlled flexible endoscope that provides the benefits of both a rigid endoscope and a computer assisted controller. The Flex System allows for the endoscope to be introduced via an operator-controlled user interface, providing visualization and surgical site access to structures within the oropharynx, and larynx. Like some other video endoscopes, visualization is provided by a digital camera incorporated in the distal end of the endoscope. The Flex System's endoscope also provides two accessory channels for use of varied flexible instruments.

The Medrobotics Flex System acceptance criteria and performance are as follows:

1. Table of Acceptance Criteria & Reported Device Performance:

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

• Clinical Study: 45 subjects.
• Data Provenance: European post-market clinical follow-up study (prospective, originating from Europe).

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

• The document does not explicitly state the number of experts or their specific qualifications (e.g., "radiologist with 10 years of experience") used to establish the ground truth for the clinical study. It mentions that "investigator visualized and accessed" the anatomical locations, implying the assessment was made by the medical professionals conducting the study.

4. Adjudication method for the test set:

• The document does not specify an adjudication method like 2+1 or 3+1 for the clinical study results. The reported percentages (e.g., "45 (100%)" or "44 (98%)") suggest direct observation and recording by the study investigators.

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 to compare human readers with and without AI assistance described in this document. The Flex System is a robot-assisted visualization and surgical access device, 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:

• The Flex System is an "operator-controlled flexible endoscope" and "robot-assisted visualization and surgical site access" device, explicitly designed for human-in-the-loop operation. Therefore, a standalone algorithm-only performance study would not be applicable or conducted for this type of device.

7. The type of ground truth used:

• Clinical Study: The ground truth was based on direct observation and assessment by the study investigators (medical professionals) during the "Five-Point Visualization & Access Procedure" and "Surgical Procedures." This is best described as expert consensus/direct observation by medical professionals.
• Bench, Animal, Electrical Safety, EMC, Biocompatibility, Sterilization, Packaging, Cleaning, Software Testing: Ground truth established through compliance with recognized standards, specifications, and validated test methodologies.

8. The sample size for the training set:

• The document does not provide details about a "training set" in the context of machine learning, as the device primarily involves robotic assistance and control rather than a learning algorithm. The software was verified and validated, but no specific training set size is mentioned.

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

• This question is not applicable as there is no mention or indication of a machine learning "training set" or corresponding ground truth establishment process for the Flex System in the provided text. The software validation refers to standard engineering verification and validation processes against requirements and specifications.

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