(149 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 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. This feature facilitates the selection of the appropriate stent length.
The provided text is a 510(k) summary for the Alveolus TB-STS™ Tracheobronchial Stent System. While it discusses the device's design, intended use, and substantial equivalence to predicate devices, it does not contain a detailed study proving the device meets specific acceptance criteria with performance metrics, sample sizes, or ground truth establishment methods.
Therefore, I cannot directly extract the detailed table of acceptance criteria and reported device performance, nor can I provide information on sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies as requested. The document focuses on demonstrating substantial equivalence rather than presenting an efficacy study with specific performance targets.
Here's what can be inferred and what information is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated or quantified in this document. The document primarily focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and intended use.
- Reported Device Performance: The document mentions "an in vivo animal (porcine) study that demonstrates that the completely covered stent is removable like the silicone stent predicates up to 28 days." This is a performance characteristic, but it's not presented with specific acceptance criteria (e.g., "removable in X% of cases within Y days").
2. Sample size used for the test set and the data provenance:
- The text mentions "an in vivo animal (porcine) study."
- Sample Size: Not specified.
- Data Provenance: In vivo animal (porcine) study. The country of origin is not specified but it's part of a US FDA submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable based on the provided text. The animal study is observational for removability, not diagnostic, so a "ground truth" established by experts in the context of diagnostic accuracy is not relevant here.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This relates to diagnostic studies with multiple readers, which is not described.
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:
- No MRMC study mentioned. This device is a medical implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the animal study on removability, the "ground truth" would likely be the direct observation/outcome of whether the stent was successfully removed or not, as assessed by the researchers/veterinarians involved in the study. No mention of expert consensus, pathology, or separate outcomes data in this context.
8. The sample size for the training set:
- Not applicable. No training set for an algorithm is mentioned.
9. How the ground truth for the training set was established:
- Not applicable. No training set for an algorithm is mentioned.
In summary, the provided document is a regulatory submission demonstrating substantial equivalence to legally marketed predicate devices, not a detailed clinical study report with a focus on specific performance criteria and efficacy endpoints.
§ 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.”