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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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