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The Wallstent® Tracheobronchial Endoprosthesis is intended for use in the treatment of tracheobronchial strictures and fistulas produced by malignant neoplasms.

The Wallstent Tracheobronchial Endoprosthesis is a self-expanding prosthesis constructed of biomedical superalloy and an elastomeric polymer. Smaller diameter models may utilize a radiopaque core. The prosthesis is a braided wire structure which may be covered with an elastomeric polymer in selected models. The outward radial force along with the ends of the device serve to stabilize the prosthesis after implanted. The prosthesis is offered in covered and uncovered version to allow physicians to select the most appropriate models based on their preference and individual patient condition. The stents purpose is to increase or maintain the inner luminal diameter of the tracheobronchial passage.

The stent is placed by means of a delivery system. The delivery system is a coaxial tubing assembly which constrains the prosthesis until it is release in a controlled manner. The release of the stent is accomplished by retracting the outer sheath. The prosthesis is packaged constrained on the delivery system ready for placement. The system is sterile and intended for single use only.

This document is a 510(k) summary for the Boston Scientific WALLSTENT® Tracheobronchial Endoprosthesis, specifically focusing on a modification of the indications for use. As such, it does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria, particularly in the context of an AI/algorithm-driven device.

This document is for a physical medical device (a stent) and describes its design, materials, and intended use. The performance data section explicitly states: "No modifications to the device were included, therefore bench data was not required. A summary of clinical cases and information from clinical literature is included in the 510(k) submission." This indicates that no new primary performance studies were conducted for this specific submission; instead, it relies on existing clinical information and literature, likely related to the predicate devices.

Therefore, I cannot extract the following information because it is not present in the provided text:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done.
6. If a standalone (algorithm only) performance study was done.
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.

This document primarily serves to demonstrate substantial equivalence to previously cleared devices for a slight modification in the stated indications for use, rather than presenting a de novo performance study with acceptance criteria for a new AI/algorithm device.

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