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The HANAROSTENT® TracheaBronchium (CCC) is indicated for use in the treatment of tracheobronchial strictures caused by malignant neoplasms.

The HANAROSTENT® Trachea/Bronchium (CCC) is a self-expanding tubular prosthesis designed to maintain patency of tracheal or/and bronchial obstructions caused by malignant tumors. It consists of a self-expandable metal stent and a delivery device. The self-expandable metal stent is made of nickel titaniumalloy (nitinol) wire that is fully covered with a silicone membrane and has one repositioning lasso at one end of the stent. The delivery device is made of polymeric materials. The stent is loaded into the distal part of the delivery device and expanded in the body by pulling the outer sheath of the delivery device. The stent and delivery device are provided sterile and are intended for single use only.

The provided text describes a medical device, the HANAROSTENT® Trachea/Bronchium (CCC), and its 510(k) submission to the FDA. This document focuses on establishing substantial equivalence to predicate devices based on intended use, technological characteristics, biocompatibility, and bench testing.

The document does not contain information about acceptance criteria, the specific study that proves the device meets acceptance criteria, sample sizes for test or training sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, or standalone algorithm performance.

Instead, the document details physical and functional attributes of the device and compares them to predicate devices to demonstrate substantial equivalence. It confirms that the device meets certain performance benchmarks through bench testing and biocompatibility standards.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance based on studies, nor can I provide details about sample sizes, expert involvement, or algorithm-specific metrics as this information is not present in the provided text.

The information that can be extracted relevant to performance and testing is as follows:

1. Table of Acceptance Criteria and Reported Device Performance:

Since explicit "acceptance criteria" for clinical performance are not stated in the document, and no clinical study results are provided, a table like the one requested cannot be fully generated. The document only lists types of bench tests performed.

2. Sample size used for the test set and the data provenance:

• The document states: "No clinical performance data is submitted in this 510(k)." and "No animal performance data is submitted in this 510(k)." Therefore, there is no test set of patient data described.
• The only tests mentioned are bench tests and biocompatibility tests, typically performed on a certain number of device units or material samples. The specific sample sizes for these bench and biocompatibility tests are not provided in this document.
• Data provenance is not applicable for a clinical or animal test set, as none were submitted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable, as no clinical test set with ground truth established by experts is mentioned.

4. Adjudication method for the test set:

• Not applicable, as no clinical test set requiring adjudication is mentioned.

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), not an AI algorithm for diagnostic imaging, and therefore an MRMC study is not relevant to its type of premarket submission.

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

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

7. The type of ground truth used:

• For the biocompatibility and bench tests, the "ground truth" would be established by industry standards (e.g., ISO, USP) and pre-defined specifications for material properties, mechanical performance, and biological response. These are not "expert consensus, pathology, or outcomes data" in the context of clinical evaluation.

8. The sample size for the training set:

• Not applicable. As this is a physical medical device and not an AI algorithm, there is no "training set" in the context of machine learning.

9. How the ground truth for the training set was established:

• Not applicable, as there is no training set for an AI algorithm.

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The AERO DV™ Tracheobronchial Stent System is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.

The Alveolus AERO DV™ Tracheobronchial Stent System described in this Notice consists of the exact same stent as the AERO™ predicate stent (K082284) but with an alternate delivery system. The Direct Visualization (DV) delivery system of AERO DV™ allows the physician to use a bronchoscope to directly view the stent as it is being positioned and deployed at the tarqet implant site. This direct visualization is made possible with a slightly larger delivery catheter lumen that allows passage of a flexible bronchoscope through the delivery catheter.

The provided text describes a medical device called the Alveolus AERO DV™ Tracheobronchial Stent System, which is a stent used to treat tracheobronchial strictures. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive details about acceptance criteria and a dedicated study to prove that the device meets those criteria.

Therefore, the requested information regarding acceptance criteria, device performance, study details, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone performance studies, and training set information is not available in the provided document.

The document primarily states:

• The AERO DV™ Tracheobronchial Stent System uses the exact same stent as a predicate device (AERO™ K082284) but with an alternate delivery system (Direct Visualization (DV) delivery system).
• The delivery system allows direct visualization using a bronchoscope.
• Substantial equivalence is claimed based on:
  • Using the same stent as K082284.
  • Materials meeting biocompatibility requirements of the FDA "Guidance for the Content of Premarket Notifications for Esophageal and Tracheal Prostheses" document.
  • Same indications for use.
  • Same principle of operation as the AERO DV™ Tracheobronchial Stent System predicate device (K071604).
• Physical test results for the delivery system were performed as specified in the FDA "Guidance for the Content of Premarket Notifications for Esophageal and Tracheal Prostheses" document (April 28, 1998). These tests "demonstrate that the device is suitable for its indicated use." Specific acceptance criteria or reported performance from these tests are not detailed.

In summary, the document asserts that the device meets regulatory requirements through substantial equivalence, supported by physical testing of the delivery system and biocompatibility data. However, the specific, quantitative acceptance criteria and detailed results of performance studies are not provided.

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