(195 days)
The WALLSTENT® Biliary Endoprosthesis is intended for use in the treatment of biliary strictures produced by malignant neoplasms.
The WALLSTENT® Biliary Endoprosthesis is a self-expanding prosthesis constructed of biomedical superalloy and an elastomeric polymer. The prosthesis is a braided wire structure. The outward radial force along with the ends of the device serve to stabilize the prosthesis after implanted. The stent's purpose is to increase or maintain the inner lumenal diameter of the biliary duct. 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 released 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.
The provided text is a 510(k) summary for a medical device (WALLSTENT® Biliary Endoprosthesis). It focuses on the substantial equivalence of an alternate delivery system for the stent, rather than the performance of the stent itself or an AI-powered device.
Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance for an AI device is not applicable and cannot be extracted from this document.
However, I can provide information relevant to the substantial equivalence claim for the alternate delivery system based on the provided text.
Here's a breakdown of the applicable information:
1. A table of acceptance criteria and the reported device performance (for the alternate delivery system):
| Acceptance Criteria (Implicit) | Reported Device Performance (Alternate Delivery System) |
|---|---|
| Deployment forces comparable to current delivery system. | Deployment forces are comparable to the current delivery system. |
| Handling characteristics comparable to current delivery system. | Handling characteristics are comparable to the current delivery system. |
| Ability to partially deploy and then reconstrain the stent. | This feature is available and demonstrated. |
2. Sample sized used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The text mentions "in vitro and in vivo deployment testing," but does not provide the number of tests, devices, or subjects used.
- Data Provenance: The studies were internal testing ("in vitro and in vivo deployment testing") conducted by Schneider (USA) Inc. The location and specific nature of "in vivo" testing (e.g., animal studies) are not detailed. It is a retrospective analysis of this testing data for the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This evaluation is based on engineering and performance testing of a physical device and its delivery system, not on medical image interpretation or diagnostics requiring expert consensus on ground truth.
4. Adjudication method for the test set:
- Not applicable. As above, this is not a study requiring human adjudication for ground truth. The evaluation likely involved objective measurements and observations by engineers/testers.
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 not an AI device or an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI device.
7. The type of ground truth used:
- The "ground truth" in this context refers to the measured performance characteristics (deployment forces, handling, ability to reconstrain) of the existing, predicate delivery system, which the alternate system aims to match.
8. The sample size for the training set:
- Not applicable. There is no AI model being trained discussed in this document.
9. How the ground truth for the training set was established:
- Not applicable. No AI model training or associated ground truth establishment is mentioned.
In summary, the document addresses the substantial equivalence of a medical device's delivery system through in vitro and in vivo testing, focusing on comparable performance characteristics rather than clinical outcomes or AI diagnostic accuracy.
§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.