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The BONASTENT® Tracheal/Bronchial Stent System is indicated for the treatment of tracheobronchial strictures caused by malignant neoplasms.

The BONASTENT® Tracheal/Bronchial (BTB) is a self-expanding tubular prosthesis designed to maintain patency of tracheobronchial strictures caused by malignant tumors. The stent is made of Nitinol wire and is weaved using a hook & cross wire construction; a silicon membrane covers the stent and is designed to prevent stent migration. Stent sizes range in diameter from 10mm to 20mm and in length from 50mm to 80mm.

The BONASTENT® Tracheal/Bronchial is available on two types of delivery devices. The Y-Shape Handle Delivery Device is used for stents with an outer diameter of 10Fr and less. The I-Shape Handle Delivery Device which is used for stents with an outer diameter larger than 10F.

The provided text describes the 510(k) Summary for the BONASTENT® Tracheal/Bronchial device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with explicit acceptance criteria and device performance metrics in the typical sense of a clinical trial. However, it does outline performance characteristics compared to its predicate.

Here's an analysis based on the information provided, framed to address your request for acceptance criteria and supporting studies where possible, while noting limitations due to the nature of a 510(k) summary for a stent:

1. Table of Acceptance Criteria and Reported Device Performance

For this specific device (a tracheal/bronchial stent), the "acceptance criteria" are implicitly defined by demonstrating equivalence to a legally marketed predicate device (AERO Tracheobronchial Stent System). The performance data supplied are comparative benchmarks rather than direct acceptance criteria against a defined threshold.

2. Sample Size Used for the Test Set and Data Provenance

The "test set" in this context refers to the samples used in bench testing.

• Sample Size: Not explicitly stated for each test, but implied to be sufficient for the validation and comparative testing performed on the stent models (e.g., 10x20 and 20x80 stents) and deployment systems.
• Data Provenance: The studies are described as "Bench Testing" and "in-vitro tests," meaning they were conducted in a laboratory environment. There is no information regarding country of origin for the data or whether it's retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable for this type of submission. This document pertains to bench testing and substantial equivalence, not a clinical study requiring expert ground truth for interpretation of medical data.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 refer to clinical data review, typically by medical experts for diagnoses or outcomes, which is not part of this bench testing summary.

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 medical device (stent) submission, not an AI diagnostic or assistive device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a medical device (stent) submission, not an algorithm.

7. The Type of Ground Truth Used

For the bench tests, the "ground truth" is defined by the physical properties measured against established engineering and material standards, or by direct comparison to the predicate device's measured performance. For instance, expansion force measurements are compared directly to the predicate's measurements. Biocompatibility relies on standardized tests.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not a machine learning or AI device.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

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