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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 CorPath 200 System is intended for use in the remote delivery and manipulation of coronary guidewires and rapid exchange balloon/stent catheters during percutaneous coronary interventional (PCI) procedures.

The CorPath 200 System is intended for use by physicians in the delivery and manipulation of coronary guidewires and rapid exchange balloon/stent catheters during percutaneous coronary intervention ("PCI") procedures. The CorPath 200 System allows the physician to deliver and manipulate guidewires and balloon/stent catheters through the coronary 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 Console, as well as angiographic monitor(s). Commercially available guidewires and balloon/stent 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 balloon/stent 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 regarding the acceptance criteria and study for the CorPath 200 System:

1. Table of acceptance criteria and reported device performance:

The document primarily focuses on the clinical outcomes of the PRECISE Clinical Study and a subsequent study evaluating radial access. It doesn't explicitly state quantitative acceptance criteria for each- metric prior to the study. Instead, the reported results are presented as evidence of safety and effectiveness, implying that these results met internal criteria for substantial equivalence.

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The CorPath 200 System is intended for use in the remote delivery and manipulation of coronary guidewires and balloon/stent catheters during percutaneous coronary intervention (PCI) procedures.

The CorPath 200 System is intended for use by physicians in the delivery and manipulation of coronary guidewires and balloon/stent catheters during percutaneous coronary intervention ("PCI") procedures. The CorPath 200 System allows the physician to deliver and manipulate guidewires and balloon/stent catheters through the coronary 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 balloon/stent 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 balloon/stent 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 a breakdown of the acceptance criteria and study information for the Corindus CorPath® 200 System based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly list "acceptance criteria" with specific thresholds in a tabular format. Instead, it presents the results of a clinical study that demonstrates the device's acceptable performance. The key performance metrics and their reported outcomes are summarized below:

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