(122 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 intervention procedures. During the use of the CorPath GRX System, the physician maneuvers interventional devices using intuitive controls under independent angiographic fluoroscopy visual guidance 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:
- Bedside Unit Which consists of the Extended Reach Arm, Robotic Drive and Single-use Cassette
- 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 describes a 510(k) premarket notification for the CorPath GRX System, a steerable catheter control system used in percutaneous coronary and vascular procedures. The submission states that the device is substantially equivalent to previously cleared predicate devices (CorPath 200 System and an earlier CorPath GRX System).
However, the document does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and a study proving the device meets those criteria. Specifically, it lacks:
- A table of acceptance criteria with reported device performance.
- Sample sizes for test sets, data provenance, specific ground truth methods, or expert qualifications for performance evaluation.
- Details on MRMC studies or standalone algorithm performance.
- Information regarding training set size or how ground truth was established for training.
The document primarily focuses on demonstrating substantial equivalence through non-clinical laboratory testing (Device Compatibility Testing and Simulated Use Testing) and referencing prior clinical evaluations of predicate devices for safety. It does not provide performance metrics or studies of the current device against specific acceptance criteria.
Therefore, I can only extract limited information based on what is available in the text:
1. A table of acceptance criteria and the reported device performance:
The document does not provide a specific table of acceptance criteria or quantitative performance metrics for the CorPath GRX System itself. It asserts that "All testing has demonstrated that the device is substantially equivalent to the predicate devices." and "The testing demonstrated that the device is safe for its intended use and can be considered substantially equivalent to the predicate devices."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not specify the sample size used for the "non-clinical laboratory tests" (Device Compatibility Testing and Simulated Use Testing) for the CorPath GRX System. It also does not mention data provenance.
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. The non-clinical testing described does not involve expert-established ground truth in the context of diagnostic or interpretive performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. The non-clinical testing described does not involve an adjudication method among experts for establishing ground truth.
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 is mentioned for the CorPath GRX System itself. This device is a steerable catheter control system, not an AI diagnostic tool, so such a study would not be directly relevant in the context of human reader improvement with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The CorPath GRX System is a robotic control system for medical procedures, inherently designed for human-in-the-loop operation, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the non-clinical laboratory tests (Device Compatibility Testing and Simulated Use Testing) conducted for the CorPath GRX System, the "ground truth" would be the engineering specifications, functional requirements, and expected performance under simulated conditions. This is not comparable to clinical ground truth types like pathology or expert consensus.
The document mentions a "clinical evaluation of the predicate device (reference K152999) demonstrates that the device is safe for use in a clinical setting." However, it does not detail the specific ground truth used in that predicate device's clinical evaluation.
8. The sample size for the training set:
Not applicable. As a robotic control system, the CorPath GRX System does not describe a "training set" in the context of machine learning or AI models. Its development would involve engineering design, calibration, and verification/validation testing.
9. How the ground truth for the training set was established:
Not applicable, for the same reasons as #8.
§ 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).