(56 days)
The Wallstent Tracheobronchial Endoprosthesis is intended for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.
The Wallstent Tracheobronchial Endoprosthesis with Permalume Covering is intended for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.
The Wallstent Tracheobronchial Endoprosthesis is intended for us in the treatment of tracheobronchial strictures produced by malignant neoplasms.
The Wallstent Tracheobronchial Endoprosthesis with Permalume Covering is indicated for use in the treatment of tracheobronchial strictures or fistulas produced by malignant neoplasms.
The Wallstent Tracheobronchial Endoprosthesis is a self-expanding prosthesis constructed of biomedical superalloy and an elastomeric polymer. Smaller diameter models may utilize a radiopaque core. The prosthesis is a braided wire structure which may be covered with an elastomeric polymer in selected models. The outward radial force along with the ends of the device serve to stabilize the prosthesis after implanted. The prosthesis is offered in covered and uncovered version to allow physicians to select the most appropriate models based on their preference and individual patient condition. The stents purpose is to increase or maintain the inner luminal diameter of the tracheobronchial passage.
The stent is placed by means of a delivery system. The delivery system is a coaxial tubing assembly which constrains the prosthesis until it is release in a controlled manner. The release of the stent is accomplished by retracting the outer sheath. The prosthesis is packaged constrained on the delivery system ready for placement. The system is sterile and intended for single use only.
This 510(k) premarket notification (K980163) for the WALLSTENT® Tracheobronchial Prosthesis and Wallstent Tracheobronchial Endoprosthesis with Permalume covering does not contain detailed acceptance criteria or a comprehensive study report with specific performance metrics suitable for a table. The document is primarily a summary demonstrating substantial equivalence to previously cleared predicate devices, focusing on an alternate delivery system.
Therefore, many of the requested details cannot be extracted directly from this submission.
Here's a breakdown of what can be inferred or stated based on the provided text, and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Deployment forces comparable to current delivery system. | "demonstrate that deployment forces ... are comparable to the current delivery system." |
| Handling characteristics comparable to current delivery system. | "demonstrate that ... handling characteristics are comparable to the current delivery system." |
| — (No mention of clinical efficacy or safety metrics as this is not a de novo or PMA submission) | — (No quantitative performance metrics like sensitivity, specificity, accuracy, or clinical outcomes are provided for the device itself or its clinical application.) |
Explanation: The "Performance Data" section explicitly states that the alternate delivery system was found substantially equivalent based on in vitro and in vivo deployment testing which demonstrated comparable deployment forces and handling characteristics to the current delivery system. These are the only mentioned performance criteria from the document.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document only mentions "in vitro and in vivo deployment testing" without detailing the number of tests, devices, or animal subjects (if applicable for in vivo).
- Data Provenance: Not specified. It's an internal study conducted by Boston Scientific Corporation, likely in their research and development facilities. It does not mention country of origin or whether it was retrospective or prospective in a clinical sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable/not specified. For in vitro and in vivo deployment testing assessing physical characteristics, "ground truth" would typically come from calibrated measurement equipment and engineering standards, rather than expert consensus on diagnostic images or clinical outcomes.
- Qualifications of Experts: Not applicable/not specified.
4. Adjudication method for the test set
- Adjudication Method: Not applicable/not specified. This type of method is usually relevant for studies involving human interpretation (e.g., radiology reads) or clinical endpoints that require review panels. For engineering performance testing, the results are typically objectively measured.
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
- MRMC Study: No. This is not an AI/imaging device. It's a medical implantable device (stent) and its delivery system.
- Effect Size of AI: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used
- Type of Ground Truth: For the "deployment forces" and "handling characteristics," the ground truth would have been established through objective engineering measurements using calibrated equipment and established test protocols. This is not "expert consensus," "pathology," or "outcomes data" in the clinical sense. It's physical property measurement.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This device does not use machine learning or AI, and therefore does not have a "training set" in that context. The development and testing would involve engineering design, prototyping, and iterative testing.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable. As there is no training set in the AI sense, there's no ground truth established for it. The ground truth for the product's engineering specifications would be derived from design requirements, material properties, and manufacturing standards.
In summary: The provided 510(k) focuses on demonstrating that a modified delivery system for an existing medical device (tracheobronchial stent) maintains comparable performance to predicate delivery systems based on engineering tests of deployment forces and handling. It is not a clinical study of a diagnostic device or AI algorithm, and therefore many of the requested details about acceptance criteria, ground truth, and study design are not present in this type of regulatory submission summary.
§ 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.”