(50 days)
The Alveolus TB-STS™ Tracheobronchial Stent System is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.
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 the possible airway injury from the stent edges. The overall stent geometry is designed to maintain a constant length and has virtually no foreshortening, thus facilitating the selection of the appropriate stent length.
This document is a 510(k) summary for the Alveolus TB-STS™ Tracheobronchial Stent System. It details the device's description, indications for use, and a claim of substantial equivalence to predicate devices, but it does not contain a study that proves the device meets specific acceptance criteria.
Instead, the document states:
"The 510(K) Notice contains summaries of physical test results, and bio-compatibility results as specified in the FDA Guidance Document for Testing Tracheal and Bronchial Stents. The data presented demonstrate that the device is biocompatible and is suitable for its indicated use."
This indicates that testing was performed, and the results summarized in the full 510(k) Notice were deemed sufficient by the FDA to demonstrate biocompatibility and suitability for intended use, leading to substantial equivalence to legally marketed predicate devices. However, the details of those tests, specific acceptance criteria, or a "study that proves the device meets acceptance criteria" as requested in the prompt, are not provided within this 510(k) summary document.
Therefore, I cannot populate the table or answer the subsequent questions directly from the provided text.
Based on the provided text, here's what can be inferred or explicitly stated:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided in this summary document. The summary states that "summaries of physical test results, and biocompatibility results as specified in the FDA Guidance Document for Testing Tracheal and Bronchial Stents" were presented in the full 510(k) Notice. It concludes that "The data presented demonstrate that the device is biocompatible and is suitable for its indicated use." | Not provided in this summary document. The summary only states that "the device is biocompatible and is suitable for its indicated use" based on the "physical test results, and biocompatibility results." Specific performance metrics tied to acceptance criteria are not detailed. |
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: Not specified.
- Data provenance: Not specified. The document states "physical test results, and biocompatibility results" indicating lab-based testing rather than patient data for performance evaluation.
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):
- This information is not applicable and not provided. The testing discussed refers to physical and biocompatibility tests, not clinical evaluations requiring expert interpretation of a test set for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable and 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:
- No. An MRMC study was not done, as this is a medical device (stent system) and the performance evaluation discussed involves physical and biocompatibility testing, not an AI or imaging diagnostic algorithm.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is not an algorithm, but a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the device's performance would be established by validated physical and chemical testing methods as per FDA guidance for tracheal and bronchial stents. This is not clinical ground truth in the sense of diagnosis.
8. The sample size for the training set:
- Not applicable; this is a physical device, not an AI algorithm requiring a training set.
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.”