(282 days)
The CorPath GRX is intended for use in the remote delivery and manipulation of guidewires and rapid exchange balloon/ stent catheters, and remote manipulation of guide catheters during percutaneous coronary intervention (PCI) procedures.
The CorPath GRX System is intended to allow physicians to deliver and manipulate commercially available coronary guidewires, rapid exchange balloon/stent catheters, and guide catheters during percutaneous coronary intervention (PCI) 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 Articulated Arm, Robotic Drive and Single-use Cassette, and the
- Remote Workspace: Which consists of the Interventional Cockpit (radiation shielded) which houses the Control Console, angiographic monitor(s), hemodynamic monitors and X-ray foot pedal.
Commercially available guidewires, rapid exchange balloon/stent catheters, and guide catheters are loaded into the Single Use Cassette. By using the joysticks or the Control Console touch screens the physician can control the Robotic Drive to advance, retract, and rotate the guide wire, advance and retract the balloon/stent catheter, and advance, retract and rotate the guide catheter. The Robotic Drive and Control Console communicate via a single communication cable.
The provided document describes the CorPath GRX System, a robotic system for remote delivery and manipulation of guidewires, balloon/stent catheters, and guide catheters during percutaneous coronary intervention (PCI) procedures. The document confirms substantial equivalence to a predicate device, the CorPath 200 System.
Here's an analysis of the acceptance criteria and study information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria in a table format with corresponding reported device performance values. Instead, it describes various tests performed to demonstrate safety and effectiveness for substantial equivalence. The focus is on functionality and performance matching the predicate device.
| Acceptance Criteria Category (Inferred) | Reported Device Performance (Summary) |
|---|---|
| Functional Equivalence | Device design and operational principles are substantially equivalent to the predicate CorPath 200 System. |
| - Manipulation of Guidewires | Allows linear and rotational movement, similar to predicate. |
| - Manipulation of Rapid Exchange Balloon/Stent Catheters | Allows linear movement, similar to predicate. |
| - Manipulation of Guide Catheters | New capability for linear and rotational movement, which the predicate did not have for guide catheters. This is a key difference but still deemed substantially equivalent based on testing. |
| Material Biocompatibility | Single-use cassette materials tested and deemed biocompatible. |
| Software Functionality | Software verification and validation testing performed. |
| Electromagnetic Compatibility (EMC) | EMC testing performed. |
| Particulate Release | Guide Catheter Particulate Analysis performed. |
| Simulated Procedure Performance | Simulated procedure testing performed. |
| In-Vivo Performance (Safety) | Successful PCI (balloon angioplasty and stent deployment) in porcine study using CorPath GRX, comparable to manual control group. |
2. Sample size used for the test set and the data provenance
- Bench Testing: The document lists several bench tests (Performance, Functional, Guide Catheter Particulate Analysis, Simulated Procedure Testing, Biocompatibility, Software V&V, EMC).
- Sample Size: Not specified. Standard testing typically uses a statistically appropriate number of units or iterations per test, but the exact numbers are not provided.
- Data Provenance: Not specified, but generally, bench tests are conducted in a controlled laboratory environment by the manufacturer.
- Pre-Clinical Study (In-vivo):
- Sample Size: Eight (8) pigs underwent PCI using the CorPath GRX System, and four (4) pigs served as a control group for manual treatment.
- Data Provenance: This was an animal study (porcine), conducted specifically for this device (prospective). Country of origin is not specified but is typically within the country of the manufacturer or a designated contract research organization.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Bench Testing: Not applicable in the sense of expert consensus for ground truth. Tests are against defined specifications or engineering standards.
- Pre-Clinical Study (In-vivo): The document implies that the study involved performing PCI and comparing outcomes, likely assessed by veterinary or interventional cardiology experts. However, the number of experts used to establish "ground truth" (e.g., successful PCI, absence of adverse events) and their specific qualifications are not explicitly stated in this document. It implies standard veterinary/clinical assessment.
4. Adjudication method for the test set
- Bench Testing: Adjudication methods are not specified. Typically, these tests are objective, with pass/fail criteria.
- Pre-Clinical Study (In-vivo): Adjudication method for the animal study outcomes (successful PCI, comparison to control) is not specified.
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, an MRMC comparative effectiveness study was not done. The CorPath GRX System is a robotic surgical assistance system, not an AI-assisted diagnostic imaging device that would typically involve human readers interpreting images. The study involved device performance during PCI procedures, not diagnostic accuracy improvement for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable in the typical sense of AI standalone performance. The CorPath GRX System is explicitly described as a "robot-assisted" system where the physician *maneuvers interventional devices using intuitive controls... using computer controlled movements." It's a human-in-the-loop system by design; it doesn't operate independently as a standalone algorithm without a physician. The pre-clinical study compared robotic-assisted PCI (human + robot) vs. manual PCI (human only).
7. The type of ground truth used
- Bench Testing: Ground truth is established by engineering specifications, functional requirements, and recognized standards for biocompatibility, software validation, and electromagnetic compatibility.
- Pre-Clinical Study (In-vivo): The ground truth for the animal study would be based on clinical outcomes observed during and after the PCI procedures in the pigs (e.g., successful guidewire advancement, balloon inflation, stent deployment, patency of the vessel, lack of complications upon necropsy/follow-up). This is outcomes data combined with direct observation and assessment by veterinary/medical professionals.
8. The sample size for the training set
- Not applicable / Not specified. The CorPath GRX System is a robotic control system for medical devices, not a machine learning or AI system that requires a "training set" in the conventional sense of data-driven model training. Its functionality is based on electromechanical design and control algorithms, not learning from large datasets.
9. How the ground truth for the training set was established
- Not applicable. As the device does not employ a machine learning model requiring a training set, the concept of establishing ground truth for a training set is not pertinent to this submission.
§ 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).