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The GORE VIABAHN® Endoprosthesis is indicated for the treatment of tracheobronchial strictures produced by malignant neoplasms.

The VIABAHN™ Endoprosthesis is a self-expanding implantable endoprosthesis that is compressed and secured on the distal end of a catheter delivery system. The catheter delivery system provides a means for implanting the endoprosthesis at a target location within the tracheobronchial tract. The endoprosthesis consists of a fluoropolymeric tube with a within the factor over its external surface. The catheter delivery system is configured with radiopaque markers and is designed for use with guidewires.

I am sorry, but based on the provided text, I cannot extract the specific details regarding acceptance criteria and the comprehensive study information you're requesting. The document is primarily a 510(k) premarket notification summary for the GORE VIABAHN™ Endoprosthesis, informing of its substantial equivalence to a predicate device and its intended use. It does not contain the detailed methodology and results of a study that would lay out acceptance criteria, sample sizes, ground truth establishment, or human-in-the-loop performance.

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets or data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. Information on a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
6. Confirmation or details of a standalone performance study.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

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The GORE VIABAHN® Endoprosthesis is indicated for the treatment of tracheobronchial strictures produced by malignant neoplasms.

The VIABAHN™ Endoprosthesis is a self-expanding implantable endoprosthesis that is compressed and secured on the distal end of a catheter delivery system. The catheter delivery system provides a means for implanting the endoprosthesis at a target location within the tracheobronchial tract. The endoprosthesis consists of a fluoropolymeric tube with a nitinol structure located over its external surface. The catheter delivery system is configured with radiopaque markers and is designed for use with guidewires.

This is a premarket notification (510(k)) for the GORE VIABAHN® Endoprosthesis. This submission is for substantial equivalence to legally marketed predicate devices, not for a new device requiring a clinical study with acceptance criteria.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable in this context.

The document states:

• "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."
• "A variety of tests, assessments, and comparisons demonstrate that the VIABAHN™ Endoprosthesis is substantially equivalent to the cited predicates in terms of composition, design, intended use, and performance attributes."

The study undertaken here is a demonstration of substantial equivalence to predicate devices, not a study setting acceptance criteria for a novel device.

Ask a specific question about this device