(38 days)
for treatment of biliary strictures produced by malignant neoplasms.
The WALLSTENT® Biliary Endoprosthesis is a self-expanding prosthesis constructed of biomedical superalloy with a radiopaque core. The prosthesis is a braided wire structure allows for self expansion. Thi; premarket notification deals with the modification of the 12 mm diameter prosthesis to increase the radial force.
The delivery system is a coaxial tubing assembly which constrains the prosthesis until it is released in a controlled manner. The release of the prosthesis is accomplished by pulling the outer tube back, thus exposing the stent and allowing gradual release and expansion of the prosthesis. The prosthesis : packaged constrained on the delivery system ready for placement. The system is steri e and intended for single use only. The fully expanded stents are offered in sizes from 1 to 12 mm.
This appears to be a 510(k) summary for a medical device (WALLSTENT® Biliary Endoprosthesis), specifically a modification to an existing device. The provided text does not contain the kind of information requested in your prompt regarding acceptance criteria, study details, ground truth, or sample sizes related to AI/algorithm performance.
The document describes:
- Device: A self-expanding biliary stent.
- Modification: Increased radial force for the 12mm diameter prosthesis by increasing wire diameter and number of wires.
- Intended Use: Treatment of biliary strictures produced by malignant neoplasms.
- Basis for Substantial Equivalence: Comparison to a predicate device based on design, materials, fabrication methods, indications for use, and mechanical testing (axial fatigue and relative radial force testing).
The prompt's questions are geared towards the validation of an AI/algorithm (e.g., acceptance criteria for diagnostic accuracy, sample sizes for test sets, ground truth establishment, MRMC studies, standalone performance). This 510(k) summary is for a physical medical device and its mechanical performance, not an AI or algorithmic diagnosis/detection system.
Therefore, I cannot provide the requested information from the given text. The text does not discuss:
- Acceptance criteria and reported device performance (for AI): No AI performance metrics.
- Sample size for test set and data provenance: No test set data.
- Number of experts for ground truth and qualifications: No expert review for ground truth.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned.
- Standalone (algorithm only) performance: No algorithm discussed.
- Type of ground truth used: Not applicable in the context of AI.
- Sample size for training set: No training set mentioned.
- How ground truth for training set was established: No training set or ground truth mentioned.
The "study" mentioned in the document refers to engineering tests like "axial fatigue and relative radial force testing" on the physical stent, not a clinical or AI performance study.
§ 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.