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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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