(29 days)
The WALLGRAFT® Tracheobronchial Endoprosthesis is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.
The Wallgraft Endoprosthesis (stent graft) consists of a metallic stent comprised of biomedical superalloy monofilament wire with a radiopaque core, braided in a tubular mesh configuration. A platinum nickel micro-cable is incorporated into the stent to enhance radiopacity of the device. A graft material comprised of braided polyester varn (PET) is adhesively bonded to the outside of the metallic stent. This design configuration results in a stent graft that is flexible, compliant, and self-expanding with the barrier characteristics of a tubular graft.
The Unistep Plus Delivery System consists of a coaxial tube system. The exterior tube serves to constrain the stent graft over the interior tube until retracted during deployment. The coaxial tubes have the capability of re-constraining the stent graft after partial deployment. A holding sleeve and stent cup, attached to the interior tube, aid in the re-constraining process.
Radiopaque marker bands situated adjacent to the proximal and distal ends of the stent graft facilitate imaging during deployment. A radiopaque marker band located on the exterior tube and a limit marker band on the interior tube function as deployment limit markers. Re-constrainment is possible up to the point where the exterior tube marker band is proximally retracted to the location of the interior tube limit marker.
The interior tube of the coaxial system contains a central lumen which will accommodate a 0.035" guide wire. The delivery system will be available in a single working length of 90 cm.
The document provided is a 510(k) summary for the WALLGRAFT® Tracheobronchial Endoprosthesis with Unistep™ Plus Delivery System. It describes the device, its intended use, and a summary of performance testing conducted to demonstrate substantial equivalence to previously cleared predicate devices.
Here's an analysis of the acceptance criteria and study information, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria for each test. Instead, it states that "All test results verified that the modified 9 F - 11 F delivery system is adequate for its intended use." This implies that the observed performance met internal company specifications or expected performance characteristics for such devices.
| Test Performed | Reported Device Performance |
|---|---|
| Total Catheter Length | Verified adequacy for intended use |
| Catheter Crossing Profile | Verified adequacy for intended use |
| Deployment Force | Verified adequacy for intended use |
| Reconstrainment Force | Verified adequacy for intended use |
| Stent Graft Securement | Verified adequacy for intended use |
| Hub to Stainless Steel Tube Tensile | Verified adequacy for intended use |
| Distal Tip Tensile | Verified adequacy for intended use |
| Inner Member Assembly Tensile | Verified adequacy for intended use |
| Valve Body to Exterior Tube Tensile | Verified adequacy for intended use |
| Deployed Stent Graft OD Post Accelerated Aging Testing | Verified adequacy for intended use |
| Biocompatibility | Verified adequacy for intended use |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes used for each test.
The data provenance is internal testing conducted by Boston Scientific Corporation. The country of origin of the data is not specified, but the submitter's address is in Maple Grove, Minnesota, USA. The testing appears to be prospective, performed specifically for this 510(k) submission to demonstrate the modified device's performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable. The study described involves performance testing of a medical device (mechanical, material, and biocompatibility testing), not a diagnostic or prognostic medical AI algorithm that requires expert-established ground truth.
4. Adjudication method for the test set
This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation or clinical endpoints, not for engineering performance testing of a device.
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
This section is not applicable. The submission is for a medical device (stent graft and delivery system), not an AI algorithm. Therefore, no MRMC study or assessment of AI assistance for human readers was performed or reported.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This section is not applicable. As stated above, this submission is for a medical device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This section is not applicable in the traditional sense of clinical ground truth. For the engineering performance tests, the "ground truth" would be the engineering specifications and established test methodologies (e.g., tensile strength required per standard, dimensional tolerances). The "truth" is whether the device meets these pre-defined performance metrics.
8. The sample size for the training set
This section is not applicable. The submission details performance testing of a physical medical device, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
This section is not applicable for the same reason as point 8.
§ 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.”