(87 days)
The Ultraflex Tracheobronchial Stent System is indicated for treatment of tracheobronchial strictures produced by malignant neoplasms.
The proposed Ultraflex Tracheobronchial Stent System is comprised of two components, a metallic expandable stent and a flexible delivery catheter. The stent is mounted on a delivery catheter. The delivery catheter is placed over a guidewire and through the working channel of an endoscope to deliver the stent. The stent is available in a variety of diameters and lengths.
The provided text is a 510(k) premarket notification for a medical device (Ultraflex Tracheobronchial Stent System). It focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study that proves the device meets specific performance acceptance criteria.
Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth cannot be extracted from this document, as it describes a different regulatory pathway (510(k) clearance based on substantial equivalence) than one requiring extensive clinical performance studies with predefined acceptance criteria for AI or diagnostic devices.
However, I can provide the following based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or provide specific performance metrics in a table. The regulatory submission is for substantial equivalence to an existing predicate device (Boston Scientific Corporation's Wallstent Tracheobronchial Stent System) for the treatment of tracheobronchial strictures produced by malignant neoplasms.
The "performance" demonstrated is that the device has "similar" design characteristics and that bench testing was conducted to evaluate features and demonstrate substantial equivalence.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable/not provided. This document states "Bench testing was conducted to evaluate the design features," implying in-vitro or simulated testing, not testing on human patient data with a "test set" in the context of diagnostic accuracy.
- Data Provenance: Not applicable/not provided. The device is a physical stent system, and the submission focuses on its physical characteristics and intended use in comparison to a predicate, not on a data-driven diagnostic or AI system.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/not provided. This is not a study involving expert-established ground truth for diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/not provided.
5. 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 is a traditional medical device submission for a physical stent, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study or AI-related effectiveness is discussed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. As above, this is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The "ground truth" in this context would implicitly be the established safety and efficacy profile of the predicate device, against which the new device's engineering and performance characteristics were compared to demonstrate equivalence.
8. The sample size for the training set
- Not applicable. No training set is mentioned as this device is a physical stent and not an AI or machine learning model.
9. How the ground truth for the training set was established
- Not applicable.
§ 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.”