(50 days)
The Wallstent® Tracheobronchial Endoprosthesis is intended for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.
The Wallstent Tracheobronchial Endoprosthesis with Permalume® Covering is intended for use in the treatment of tracheobronchial strictures or 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.
The provided text is a 510(k) premarket notification summary for the WALLSTENT® Tracheobronchial Endoprosthesis, specifically addressing an alternate delivery system. This document primarily focuses on establishing substantial equivalence to a predicate device for this alternate delivery system, rather than providing detailed acceptance criteria and performance data for the endoprosthesis itself.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for the device (the endoprosthesis) is largely not present in the provided text. The document states that the alternate delivery system was found substantially equivalent based on in vitro test results demonstrating comparable deployment forces and handling characteristics to the current delivery system.
Here's a breakdown of what can be extracted about the alternate delivery system and what is missing regarding the endoprosthesis:
Information available regarding the alternate delivery system:
- Acceptance Criteria & Performance:
- Acceptance Criteria (Implicit): The alternate delivery system should have deployment forces and handling characteristics comparable to the predicate delivery system.
- Reported Device Performance: In vitro test results demonstrate that deployment forces and handling characteristics are comparable to the current delivery system.
- Study Type: In vitro testing.
Missing Information (or implicitly not applicable) for the alternate delivery system and entire device (endoprosthesis):
- A table of acceptance criteria and the reported device performance: While comparability is stated for the delivery system, specific quantifiable criteria and results are not provided for either the delivery system or the stent itself.
- Sample size used for the test set and the data provenance: Not specified for the in vitro tests of the alternate delivery system. No information for the endoprosthesis.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as the testing mentioned is in vitro for the delivery system, not involving expert interpretation of patient data.
- Adjudication method for the test set: Not applicable for in vitro testing of the delivery system.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a physical medical device (stent and delivery system), not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the delivery system, "ground truth" seems to be the performance of the predicate delivery system in in vitro tests. For the endoprosthesis itself, the document doesn't provide this detail.
- The sample size for the training set: Not applicable. This is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
§ 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.”