(69 days)
The CorPath GRX System is intended for use in the remote delivery and manipulation of guidewires and rapid exchange catheters, and remote manipulation of guide catheters during percutaneous coronary and vascular procedures.
The CorPath GRX System is intended to allow physicians to deliver and manipulate commercially available guidewires, rapid exchange catheters and guide catheters during percutaneous coronary and vascular procedures. During the use of the CorPath GRX System, the physician maneuvers interventional devices using intuitive controls under independent angiographic fluoroscopy visual quidance using computer controlled movements while in a seated position away from the radiation source.
The CorPath GRX System is composed of the following two functional sub-units:
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- Bedside Unit Which consists of the Extended Reach Arm, Robotic Drive and Single-use Cassette
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- Remote Workspace Which consists of the Control Console, angiographic monitor(s), hemodynamic monitors, X-ray foot pedal, and optional Interventional Cockpit.
Commercially available guidewires, rapid exchange catheters, and guide catheters are loaded into the Singleuse Cassette. By using the joysticks or the Control Console touch screen, the physician can control the Robotic Drive to advance, retract, and rotate the guidewire, advance and retract the rapid exchange catheter, and advance, retrace, and rotate the guide catheter. The Robotic Drive and Control Console communicate via a single communication cable.
The provided text is a 510(k) summary for the CorPath GRX System, a medical device used for remote delivery and manipulation of guidewires and catheters during percutaneous coronary and vascular procedures. However, the document does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria for the following reasons:
- This is a 510(k) for a modified device, not a new AI/algorithm driven device. The current 510(k) (K221464) describes a modification to a previously cleared device (CorPath GRX System, K202275). The modification is specifically "limited to modified cassette design to allow an alternate off-the-shelf hemostasis valve to be utilized with the Single-Use Cassette."
- The testing described is for substantial equivalence of the modification. The "Verification/validation testing" mentioned focuses on demonstrating that the modified system is substantially equivalent to the predicate, specifically through "Performance Testing Single-Use Cassette." This is typical for a 510(k) update for a minor change.
- There is no mention of AI, machine learning, or algorithm performance. The questions you've posed (acceptance criteria for AI, training/test sets, human readers, ground truth, etc.) are highly relevant to AI/ML medical devices where the algorithm's performance is the primary subject of evaluation. This document describes a mechanical/hardware modification, not an AI component.
Therefore, based solely on the provided text, I cannot answer the questions about acceptance criteria for an AI device or a study proving an AI device meets those criteria. The information required (e.g., performance metrics like sensitivity/specificity, sample sizes for AI validation, expert consensus for ground truth) is not present because this 510(k) is not about an AI-driven device or its performance.
§ 870.1290 Steerable catheter control system.
(a)
Identification. A steerable catheter control system is a device that is connected to the proximal end of a steerable guide wire that controls the motion of the steerable catheter.(b)
Classification. Class II (performance standards).