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

The next generation GORE Tri-Lobe Balloon Catheter is designed to be used in conjunction with the implantation of an endoprosthesis. The triangular arrangement of balloons allows for continuous blood flow through the implanted device during inflation of the balloon. The next generation GORE Tri-Lobe Balloon Catheter is available in two balloon sizes.

This 510(k) submission for the GORE Tri-Lobe Balloon Catheter references bench testing performance evaluations to demonstrate that the device met acceptance criteria and was comparable to predicate devices. However, it does not provide specific details about the acceptance criteria or the study methodology beyond this general statement.

Therefore, I cannot provide a complete answer to your request with the given information for many of the sections.

Here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: Not explicitly stated in the provided text. The document broadly mentions "met the acceptance criteria."
Reported Device Performance: "demonstrated that the next generation GORE Tri-Lobe Balloon Catheter met the acceptance criteria and that its performance was comparable to the predicate devices."

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

Sample Size for Test Set: Not specified.
Data Provenance: The document states "In vitro bench testing performance evaluations," indicating laboratory testing, not human data. No country of origin is mentioned for data. It is inherently "prospective" as it's testing of the new device.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This was bench testing, not an expert-driven assessment of medical images or conditions.

4. Adjudication Method for the Test Set

Not applicable. This was bench testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This was bench testing. MRMC studies are typically for evaluating diagnostic accuracy with human readers.

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

While the device itself is a standalone medical device, the context of this question usually refers to AI algorithms tested in isolation. Since this is a physical medical device (balloon catheter), this question isn't directly applicable in the AI context implied. The performance evaluation was on the device's physical and mechanical properties.

7. The Type of Ground Truth Used

The "ground truth" for bench testing typically refers to engineering specifications, physical measurements, or established mechanical properties. The document doesn't specify what these were, but it would have been objective physical measurements (e.g., burst pressure, inflation/deflation times, dimensions, material integrity).

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

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

Not applicable, as there is no training set for a physical device.

Summary of what is known from the provided text:

• Study Type: In vitro bench testing.
• Purpose: To demonstrate the device met acceptance criteria and was comparable to predicate devices.
• Conclusion: The device met acceptance criteria, performance was comparable to predicate devices, and no new safety or effectiveness issues were raised.

Key Missing Information: The specific acceptance criteria (e.g., maximum burst pressure, specific inflation/deflation characteristics, material strength requirements) and the detailed methodology of the bench testing are not provided in this 510(k) summary. These details would typically be found in the full submission.

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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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