(179 days)
The GORE® Tri-Lumen Catheter (TLC) is a multi-lumen catheter indicated for use in endovascular procedures requiring multiple guidewires and through-and-through access, in which the catheter leading tip exits the patient, for the implantation of branched stent grafts. Standard techniques for placement of vascular access sheaths, catheters, and wires should be employed.
The GORE® Tri-Lumen Catheter (TLC) is a 140cm long multi-lumen accessory catheter designed to assist with multiple wire introduction and control during endovascular procedures. The central lumen can accommodate one 0.035" guidewire or two 0.018" guidewires while the two auxiliary lumens can each accommodate one 0.014" quidewire. The trailing end of the device has two distinct extension tubes to assist in the introduction of the guidewires into the auxiliary lumens. The leading end of the device is radiopaque to assist in visibility under fluoroscopy. The GORE® Tri-Lumen Catheter is designed to minimize entanglement of multiple quidewires and facilitate through and through access during cardiovascular procedures with fewer snaring maneuvers.
The provided text describes the 510(k) premarket notification for the GORE Tri-Lumen Catheter (TLC), primarily focusing on its substantial equivalence to a predicate device. It details the device's technical characteristics, intended use, and the performance data gathered. However, the document does not present "acceptance criteria and the study that proves the device meets the acceptance criteria" in the format typically used for AI/ML device evaluations, which would involve metrics like sensitivity, specificity, or AUC against a ground truth.
Instead, the performance data section (page 8) focuses on engineering and biocompatibility testing for a medical catheter, confirming its functionality and safety characteristics by comparing it to established standards (BS EN ISO 10555-1:2013) and a predicate device. The information provided is for a physical medical device, not an AI/ML algorithm.
Therefore, many of the specific questions regarding acceptance criteria for AI models, sample sizes for test sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance are not applicable or cannot be answered from the provided text for an AI/ML device.
Here's an attempt to extract relevant information and note the absence of others based on your request, understanding that the device is a physical catheter, not an AI solution:
1. A table of acceptance criteria and the reported device performance
Since this is a physical medical device (catheter) and not an AI/ML algorithm, the "acceptance criteria" are based on engineering performance tests and biocompatibility, demonstrating that the device meets general requirements for intravascular catheters and is substantially equivalent to a predicate. The document doesn't provide specific quantitative acceptance criteria or reported performance values in a table format that are directly comparable, but lists the types of tests performed.
| Acceptance Criteria Category (based on ISO 10555-1:2013 general requirements & equivalency) | Reported Device Performance (as described) |
|---|---|
| Guidewire Compatibility | Verified by testing |
| Catheter Tip Bond Strength | Verified by testing |
| Radiopacity | Verified by testing (Radiopaque Tip) |
| Device Dimensions | Verified by testing |
| Device Trackability | Verified by testing |
| Device Pushability | Verified by testing |
| Device Flushability | Verified by testing |
| Biocompatibility | Biocompatible per ISO 10993-1 |
| Design Verification | Performed |
| Design Validation | Performed |
| Sterilization Validation | Performed (Ethylene Oxide method) |
| Packaging Integrity | Performed |
| Product Shelf-Life | Performed |
| Introducer Sheath Compatibility | Performed (Compatible with ≥ 12 Fr catheters) |
| Device Torqueability | Performed |
| Surface Integrity | Performed |
| Clinical Performance (safety and effectiveness) | Performed safely and effectively with no procedural or device related events in an Early Feasibility Study |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: The clinical "test set" (referred to as an Early Feasibility Study) involved 13 patients.
- Data Provenance: The study was an "Early Feasibility Study to evaluate the initial safety of an investigational aortic stent graft," which used the GORE Tri-Lumen Catheter as an accessory device. The document does not specify the country of origin of the data, but W.L. Gore & Associates, Inc. is a U.S.-based company, suggesting the study likely took place in the US or a region with similar regulatory standards. The study appears to be prospective as it involved treating patients with an investigational device.
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. For a physical catheter, "ground truth" as understood in AI/ML is not relevant. The assessment of the catheter's performance in the clinical study would have been conducted by the medical professionals involved in the procedures. The document states the "intended user" includes "Physicians trained in and/or familiar with endovascular procedures and similar devices," which may include "vascular surgeons, interventional radiologists, and interventional cardiologists." No specific number or qualifications for establishing ground truth are provided, as clinical observation and reporting of events served as the outcome assessment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As this is not an AI/ML device requiring interpretative output to be adjudicated against a ground truth, no such adjudication method is mentioned or relevant. The clinical study assessed the catheter's safe and effective performance.
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
Not applicable. This is not an AI/ML device, so no MRMC comparative effectiveness study was performed, and thus no effect size related to AI assistance can be reported.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the clinical performance, the "ground truth" was based on outcomes data and observational reports during the Early Feasibility Study. Specifically, it states, "The GORE® Tri-Lumen Catheter performed this task safely and effectively with no procedural or device related events reported as a result of using the catheter." This indicates safety and efficacy were assessed through direct observation of procedural success and lack of adverse events.
8. The sample size for the training set
Not applicable for a physical medical device. There is no concept of a "training set" for AI/ML in this context. The device's design and manufacturing are based on engineering principles and validated through the performance tests mentioned.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI/ML model for this device.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).