(25 days)
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:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method for the test set.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
- Confirmation or details of a standalone performance study.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
§ 878.3720 Tracheal prosthesis.
(a)
Identification. The tracheal prosthesis is a rigid, flexible, or expandable tubular device made of a silicone, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the trachea or trachealbronchial tree. It may be unbranched or contain one or two branches. The metal tracheal prosthesis may be uncovered or covered with a polymeric material. This device may also include a device delivery system.(b)
Classification. Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”