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The Tri-Lobe Balloon Catheter is intended to assist in the dilatation of self-expanding endoprostheses in large diameter vessels.

The GORE Tri-Lobe Balloon Catheter is a dual lumen catheter with a low pressure compliant balloon attached to the distal end of the catheter. The balloon is a tri-lobe design to allow for limited blood flow when used to touch up an endoprosthesis. The catheter is designed to be used with a 0.035" guidewire. Two 304 stainless steel markers provide angiographic visualization of the balloon length and facilitate intravascular placement of the balloon prior to inflation. The GORE Tri-Lobe Balloon Catheter is provided sterile for single-use.

Here's an analysis of the provided 510(k) summary regarding the GORE Tri-Lobe Balloon Catheter, focusing on acceptance criteria and supporting studies:

This 510(k) summary is for a medical device (GORE Tri-Lobe Balloon Catheter) seeking market clearance by demonstrating substantial equivalence to predicate devices, not for a software algorithm. Therefore, many of the typical acceptance criteria and study details relevant to AI/ML or diagnostic software (like sensitivity, specificity, MRMC studies, training/test set details, ground truth establishment) are not applicable.

The "acceptance criteria" for this type of device primarily revolve around meeting safety and performance specifications through mechanical/physical testing and demonstrating manufacturing quality, rather than diagnostic accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the device (a balloon catheter), the 'acceptance criteria' are related to the physical performance and integrity of the device. The document states that "All device integrity test results for the GORE Tri-Lobe Balloon Catheter met specified requirements," implying that the device successfully passed pre-defined performance benchmarks. However, the specific quantitative acceptance criteria (e.g., burst pressure minimum, inflation/deflation times, guidewire compatibility) are not detailed in this summary.

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

• Sample Size for Test Set: Not specified. Device integrity testing typically involves a statistically relevant sample size of the manufactured devices for each test (e.g., burst testing, fatigue testing). The specific number of catheters tested for "device integrity" is not provided in this summary.
• Data Provenance: Not applicable in the context of clinical data for AI/ML. The data provenance would be from internal lab testing conducted by W. L. Gore & Associates, Inc. (developer and manufacturer). It is retrospective in the sense that the testing was performed on completed devices before submission.

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

• Not applicable. "Ground truth" in the context of diagnostic accuracy is not relevant here. The "ground truth" for mechanical testing is simply the physical properties or behavior of the device under test, measured by calibrated equipment and assessed against engineering specifications. No human experts are establishing a "ground truth" in this context in the way they would for medical image interpretation.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements in expert annotation for diagnostic ground truth. This is not relevant for physical device integrity testing. The "adjudication" would involve engineering review and quality control processes to ensure test results are valid and meet specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported. MRMC studies are typically used for evaluating the performance of diagnostic imaging devices or software algorithms where human interpretation is involved. This device is a catheter, not a diagnostic tool requiring human interpretation comparison.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Yes, a form of "standalone" performance was inherently evaluated through the device integrity testing. The catheter's physical performance (e.g., balloon inflation, pressure resistance, guidewire tracking) was assessed independently of human interaction during these lab tests, against engineering specifications. It's not an "algorithm" in the AI sense, but the device's functional performance was evaluated in isolation.

7. Type of Ground Truth Used

• The "ground truth" for device integrity testing is based on engineering specifications and validated test methods. This includes:
  • Physical measurements: Dimensions, material properties.
  • Functional performance standards: Burst pressure limits, inflation/deflation characteristics, fatigue life, guidewire compatibility, bond strength, tensile strength, marker visibility.
  • These standards are often derived from industry benchmarks, regulatory guidance, and internal risk assessments.

8. Sample Size for the Training Set

• Not applicable. This is a medical device, not an AI/ML algorithm that requires a "training set" of data. The manufacturing process is refined through development and iterative testing, but not in the sense of an algorithm training on data.

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

• Not applicable, as there is no "training set" in the AI/ML sense for this device. For the manufacturing process and device design, the "ground truth" (i.e., optimal design and manufacturing parameters) would be established through:
  • Engineering design principles
  • Material science knowledge
  • Pre-clinical testing (benchtop, ex-vivo, in-vivo animal studies)
  • Quality control processes
  • Regulatory requirements and standards.

Summary of the Study

The study performed was focused on "device integrity testing." This involved a series of laboratory tests designed to ensure the physical and functional aspects of the GORE Tri-Lobe Balloon Catheter met its design specifications and would perform adequately for its intended use. The summary states that "All device integrity test results for the GORE Tri-Lobe Balloon Catheter met specified requirements," indicating successful completion of these tests. This type of testing is standard for demonstrating the safety and effectiveness of physical medical devices like catheters to support a 510(k) submission for substantial equivalence. The predicate devices (ANCURE® Iliac Balloon Catheter, Equalizer™ Balloon Catheter, LDOB Occlusion Balloon Catheter) also served as benchmarks for establishing equivalence in features, materials, and intended use.

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