(284 days)
The MERIT ENDOTEK AEROmini Tracheobronchial Stent System is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.
The MERIT ENDOTEK AEROmini Tracheobronchial Stent System is comprised of two components: the radiopaque self-expanding nitinol stent and the delivery system. The stent is completely covered with a biocompatible polyurethane membrane. The stent expansion results from the physical properties of the metal and the proprietary geometry. 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 stent is deployed endoscopically with a dedicated delivery system with or without the aid of fluoroscopic imaging. The delivery system consists of two coaxial sheaths. The exterior sheath serves to constrain the stent until the sheath is retracted during deployment. The stent remains constrained by the delivery system until the trigger is pulled beyond the white deployment threshold mark located between the trigger and hand grip. This feature allows for repositioning of the stent proximally. In addition, the procedure can be aborted and the entire system can be withdrawn en bloc at any time before the trigger is pulled beyond the white deployment threshold mark located between the trigger and hand grip. A radiopaque tip and marker on the inner shaft aid the operator in determining stent position in relation to the deployment threshold mark, where repositioning or en bloc withdrawal is no longer possible. The inner sheath of the delivery system contains a central lumen that will accommodate a 0.035" guide wire. This feature is designed to allow guidance of the delivery system to the intended implant site while minimizing the risk of airway injury from the delivery system tip.
The provided text describes the regulatory clearance of the AEROmini™ Tracheobronchial Stent System, focusing on its substantial equivalence to a predicate device rather than a study proving the device meets predefined acceptance criteria for AI/algorithm performance. Therefore, most of the requested information regarding AI/algorithm performance, such as sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone performance, is not available in the given document.
However, the document does list the acceptance criteria in general terms, and states that studies were conducted to meet these criteria, thereby demonstrating substantial equivalence.
Here's the information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category (as per FDA Guidance and Recognized Standards) | Reported Device Performance |
|---|---|
| Mechanical Performance (based on FDA Guidance for Esophageal and Tracheal Prosthesis) | All tests successfully conducted, demonstrating adherence to established criteria and substantial equivalence. Specific tests include: |
| Deployment Testing | Successfully conducted |
| Expansion Force Testing | Successfully conducted |
| Compression Force Testing | Successfully conducted |
| Dimensional Testing | Successfully conducted |
| Tensile Strength Tests | Successfully conducted |
| Guide Wire Compatibility | Successfully completed |
| Delivery Device Working Length | Successfully completed |
| Delivery Device Stent Pod OD | Successfully completed |
| Delivery Device Shaft OD | Successfully completed |
| Trigger Stroke | Successfully completed |
| Insertion Force | Successfully completed |
| Distal Tip Insertion & Flexibility/Kink Resistance Performance | Successfully completed |
| Repositioning Tests | Successfully completed |
| Delivery System Deployment Accuracy | Successfully completed |
| Stent Expansion & Condition After Deployment | Successfully completed |
| System Integrity | Successfully completed |
| Stent Foreshortening | Successfully completed |
| Removal Migration & Removal Force | Successfully completed |
| AM-Strut Height | Successfully completed |
| Suture Purse String Suture Tensile | Successfully completed |
| Stent Tensile | Successfully completed |
| Stent Fatigue | Successfully completed |
| Cover Integrity After Fatigue | Successfully completed |
| Coating Integrity After Fatigue | Successfully completed |
| Stent Spring Back After Fatigue | Successfully completed |
| Compression Force After Fatigue | Successfully completed |
| Expansion Force After Fatigue | Successfully completed |
| Trigger Safety | Successfully completed |
| Delivery System Tensile Strength Tests | Successfully completed |
| Imaging Compatibility | All tests successfully conducted, demonstrating adherence to established criteria and substantial equivalence. Specific tests include: |
| Fluoroscopic Visibility of Deployment Catheter | Successfully completed |
| Endoscopic Visibility of Deployment Catheter | Successfully completed |
| MR Compatibility (ASTM F2052, F2119, F2182, F2213, F2503) | Successfully completed |
| Biocompatibility (ISO 10993 series) | All tests successfully conducted, demonstrating adherence to established criteria and substantial equivalence. Specific tests include: |
| Cytotoxicity (ISO 10993-5) | Successfully completed |
| Sensitization (ISO 10993-10) | Successfully completed |
| Implantation (ISO 10993-6) | Successfully completed |
| Irritation (ISO 10993-10) | Successfully completed |
| Material Mediated Pyrogenicity (USP 36) | Successfully completed |
| Chemical Characterization (ISO 10993-17, 10993-18) | Successfully completed |
| Sterilization (ISO 11135-1, ISO 10993-7) | All tests successfully conducted, demonstrating adherence to established criteria and substantial equivalence. Specific tests include: |
| Ethylene Oxide Sterilization Residuals | Successfully completed |
| Packaging Performance (ISO11607-1, ASTM D4169, ISO 2233) | All tests successfully conducted, demonstrating adherence to established criteria and substantial equivalence. Specific tests include: |
| Seal Peel Strength | Successfully completed |
| Visual Inspection | Successfully completed |
| Bubble Emission | Successfully completed |
| Atraumatic Tip | Successfully completed |
2. Sample size used for the test set and the data provenance:
- Not applicable as this document does not describe an AI/algorithm-based study. The performance testing refers to physical and material properties of the medical device itself. No specific sample sizes for these tests are provided in the summarized information beyond noting that "a battery of tests was performed."
- Data provenance: Not specified. This typically refers to laboratory testing of the physical device components and system.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth in the context of AI/algorithm performance is not relevant here. The "ground truth" for the device's performance is established by recognized performance standards and guidance documents (e.g., ISO, ASTM, FDA guidance), against which the device's physical and biological properties are measured.
4. Adjudication method for the test set:
- Not applicable. Adjudication methods are typically used in clinical studies or expert review processes for AI algorithms. Here, device performance is measured against objective technical standards.
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. This document describes a traditional medical device (stent) and its physical, mechanical, and biological performance characteristics, not an AI or imaging diagnostic device that would involve human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. Not an AI/algorithm.
7. The type of ground truth used:
- The "ground truth" for this device's performance is based on recognized performance standards and guidance documents (e.g., FDA Guidance for the Content of Premarket Notifications for Esophageal and Tracheal Prosthesis, ISO, and ASTM standards) which define the expected physical, mechanical, and biological properties for tracheal prostheses.
8. The sample size for the training set:
- Not applicable. No AI/algorithm training set.
9. How the ground truth for the training set was established:
- Not applicable. No AI/algorithm training set.
§ 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.”