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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.

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.

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The GORE® Molding and Occlusion Balloon Catheter is intended for temporary occlusion of large vessels or to assist in the expansion of selfexpanding endovascular prostheses (stent grafts).

The GORE® Molding and Occlusion Balloon Catheter is a sterile (EtO), single use, single-lobed polyurethane balloon catheter. The compliant polyurethane balloon is mounted on the leading end of a 3 lumen catheter shaft (two inflation lumens and one quidewire lumen). Termination of the leading end of the catheter is an atraumatic catheter leading tip for smooth transition from the quidewire to catheter transition. Radiopaque markers (approximately 40 mm apart) indicate the proximal and distal end of the balloon which aid in proper balloon placement under fluoroscopy. Both of the (2) inflation lumens are in communication with each end of the balloon to facilitate balloon catheter preparation, inflation and deflation. At the trailing end of the balloon catheter is a dual port (balloon inflation and quidewire) yarm. The inflation port of the y-arm is in communication with both of the balloon inflation lumens and is affixed with a luer lock and three way stopcock via an extension tube. The quidewire lumen of the v-arm allows introduction of a 0.035" (0.89 mm) diameter guidewire for over-the-wire access. The trailing end of the quidewire lumen is affixed with a flushing / guidewire port with luer lock used for flushing the guidewire lumen. The balloon catheter proximal y-arm is provided within a housing which contains markings of the balloon length and inflation range diameter. The balloon can be inflated to diameters of 10 mm to a maximum inflation diameter of 37 mm. The balloon catheter profile is 10 Fr introducer sheath compatible.

Here's an analysis of the provided text regarding the acceptance criteria and study for the GORE Molding and Occlusion Balloon Catheter:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes a series of "Design Verification Testing" activities as the performance data. While specific pass/fail criteria (e.g., a numerical range for "Inflation Time") are not explicitly listed in this summary, the document states that these tests "demonstrated the subject device performed as intended and was substantially equivalent to the predicate device." This implies that the device met internal specifications and expectations derived from the predicate device's performance.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify the exact sample sizes for each of the "Design Verification Testing" activities. It only references "bench study" data.

• Sample Size: Not specified.
• Data Provenance: The studies were "bench studies," which are laboratory-based tests. The country of origin is not explicitly stated, but the company (W.L. Gore & Associates) is based in the U.S. (Flagstaff, Arizona), suggesting the studies were likely conducted in the U.S. These are retrospective tests performed to verify design specifications.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. This device is a physical medical device, and the "ground truth" for its performance is established through objective engineering and materials testing, not through expert human interpretation of data like in an AI/imaging device.

4. Adjudication Method for the Test Set:

Not applicable, as the tests are objective bench tests.

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 a physical medical device, not an AI or imaging diagnostic tool that would involve human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This is a physical medical device.

7. The Type of Ground Truth Used:

The ground truth used for this device's performance evaluation is based on objective engineering specifications, material properties, and functional requirements for a balloon catheter intended for occlusion and stent graft expansion. These are derived from established medical device standards and comparison to a predicate device. For example, "Burst Volume" would have a defined expected value, and the tested device's performance would be compared against that.

8. The Sample Size for the Training Set:

Not applicable. There is no concept of a "training set" for physical medical device bench testing in the same way there would be for an AI algorithm. The design and manufacturing processes are refined based on general engineering principles and iterative development, not a specific training dataset.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set in the context of this device. The "ground truth" for the device's design and manufacturing is derived from industry standards, regulatory requirements, scientific principles, and iterative design and testing.

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