(141 days)
The Alveolus TB-STS™ Tracheobronchial Stent System is indicated for use in the treatment of tracheobronchial strictures and airway compression (stenosis) produced by malignant neoplasms. Because the device is removable it may also be used to treat conditions such as tracheo-esophageal fistula resulting from malignancies and strictures resulting from surgical anastomosis of the airway in patients with malignancies.
The Alveolus Tracheobronchial Stent Technology System is comprised of two components: the radiopaque stent and the delivery system. The nitinol stent is completely covered with a biocompatible polyurethane (ChronoFlex™) membrane and is self-expanding. The inner lumen of the expanded stent is coated with a hydrophilic polymer to improve lubricity. The stent expansion results from the mechanical properties of the metal and the proprietary geometry. The stent is designed with a slightly larger diameter near the distal and proximal ends to minimize the possibility of migration. The stent ends are slightly vaulted inwardly in order to minimize possible airway injury from the stent edges. The overall stent geometry is designed to maintain a constant length over the entire range of possible diameters. As a result of this unique design the stent has virtually no foreshortening, thus facilitating the selection of the appropriate stent length.
The provided text is a 510(k) premarket notification for a medical device (Alveolus, TB-STS™ Tracheobronchial Stent System) and focuses on establishing substantial equivalence to previously cleared devices. It does not contain information about specific acceptance criteria or a detailed study proving the device meets particular performance metrics.
However, based on the text, I can extract information related to the device and the general approach to demonstrating its safety and effectiveness:
Acceptance Criteria and Reported Device Performance:
The document does not specify quantitative acceptance criteria. Instead, it relies on demonstrating substantial equivalence to predicate devices, which implies the new device performs at least as well as the predicates for its intended use.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (Not specified as quantitative metrics) | The data presented demonstrate that the device is biocompatible and is suitable for its indicated use. |
| (Implied: Mechanical properties similar to predicates) | Stent expansion results from the mechanical properties of the metal and the proprietary geometry. Stent designed with a slightly larger diameter near the distal and proximal ends to minimize migration. Stent ends slightly vaulted inwardly to minimize airway injury. Stent geometry designed to maintain constant length over entire range of possible diameters, resulting in virtually no foreshortening. |
| (Implied: Biocompatibility) | The device is biocompatible. |
Study Information (Based on available text):
- Sample size used for the test set and the data provenance: Not explicitly mentioned. The document refers to "summaries of physical test results, and biocompatibility test results" but does not detail the specific sample sizes or data provenance (e.g., country of origin, retrospective/prospective).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The document does not describe a clinical study with ground truth established by experts. It refers to "physical test results" and "biocompatibility test results."
- Adjudication method for the test set: Not applicable. No clinical study with adjudication is described.
- 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 tracheobronchial stent 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 medical device, not an algorithm.
- The type of ground truth used: For physical and biocompatibility testing, the "ground truth" would be established according to standard testing methodologies and regulatory guidelines (e.g., ISO standards for biocompatibility). The document states the tests were conducted "as specified in the FDA Guidance Document for Testing Esophageal and Tracheal Prostheses (April 28, 1998)."
- The sample size for the training set: Not applicable. This document describes a medical device, not a machine learning algorithm that requires a training set.
- How the ground truth for the training set was established: Not applicable. (See above)
Summary of Device and Evidence:
The Alveolus, TB-STS™ Tracheobronchial Stent System is described as a self-expanding nitinol stent, completely covered with a biocompatible polyurethane membrane, and coated with a hydrophilic polymer. Its design aims to minimize migration, airway injury, and foreshortening.
The device's safety and effectiveness were demonstrated by showing substantial equivalence to a number of previously cleared predicate devices, including:
- Alveolus, Inc. TB-STS™ Tracheobronchial Stent System [510(k) K030947]
- Boston Scientific Corp. Inc. Ultraflex™ Tracheobronchial Stent System [501(k) Number K963241]
- Vascular Architects, Inc. aSpire™ Covered Stent and CONTROLLED EXPANSION™ Delivery System [510(k) Number K003173 and K012544]
The submission included "summaries of physical test results, and biocompatibility test results as specified in the FDA Guidance Document for Testing Esophageal and Tracheal Prostheses (April 28, 1998)." These tests established that the device is biocompatible and suitable for its indicated use. The materials used have an "established history of use in clinical applications."
In essence, the "study" demonstrating the device meets "acceptance criteria" is a demonstration of substantial equivalence through physical and biocompatibility testing consistent with FDA guidance, rather than a clinical trial with specific performance metrics and ground truth established by experts.
§ 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.”