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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.

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.

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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 edges are significantly curved inwardly to minimize possible airway irritation. 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 selection.

It looks like the provided text is a 510(k) summary for a medical device (Alveolus TB-STS™ Tracheobronchial Stent System) and focuses on establishing its substantial equivalence to previously cleared devices. It describes the device, its indications for use, and mentions that physical and biocompatibility test results were submitted.

However, the document does not contain the detailed information necessary to answer your specific questions regarding acceptance criteria and a study proving the device meets those criteria. Specifically, it lacks:

• A table of acceptance criteria and reported device performance.
• Details about a clinical study, including sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods.
• Information on MRMC comparative effectiveness studies or standalone algorithm performance.

The document primarily focuses on establishing substantial equivalence based on material properties, design, and general testing, rather than reporting on specific clinical performance against predefined acceptance criteria from a human-device interaction study.

Therefore, I cannot extract the requested information from the provided text.

Ask a specific question about this device

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:

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.

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