(70 days)
The Cook® Zilver® 635™ Biliary Stent is indicated for use in palliation of malignant neoplasms in the biliary tree.
The Zilver® 635 " Biliary Stent is a self-expanding, nitinol stent designed for excellent radial strength and optimal longitudinal flexibility. Constructed from a series of interconnected Z-shaped segments, the stent conforms to the shape of the biliary system and provides circumferential scaffolding throughout the stent's length. Gold radiopaque markers on each end of the Zilver® 635™ Biliary Stent, along with one radiopaque marker at the distal end of the delivery system, allow precise positioning of the stent. The stent's interconnected Z-shaped segments also keep foreshortening to a minimum.
The Zilver® 635" Biliary Stent comes preloaded in a 6 French delivery system. The stent is deployed with the use of a simple hand held device. The stent is available in unrestrained outer diameters of 4, 5, 6, 7, 8, 9 and 10 mm and in lengths of 20, 30, 40, 50, 60 and 80 mm. The 9, 10, 12, and 14 mm diameter stent with a cannula outside diameter of 1.6 mm is an addition to this product line.
The Cook Zilver® 635™ Biliary Stent is a medical device and thus does not involve AI/ML. Much of the requested information (e.g., sample size for training set, number of experts, adjudication method) is not applicable to this type of medical device as it is not an AI/ML device.
Here's a breakdown of the acceptance criteria and study information provided for the Cook Zilver® 635™ Biliary Stent, based on the provided text:
1. Table of acceptance criteria and reported device performance:
The provided text generally describes the types of tests performed rather than specific numerical acceptance criteria or detailed results for each test. The summary states that the results "provide reasonable assurance that the device has requirements for its use as a biliary stent," indicating that acceptance criteria were met.
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Deployment | Demonstrated reliability |
| a. Profile | (Implicitly met reliable design) |
| b. Deployment Accuracy | (Implicitly met reliable design) |
| c. Stent length and Change due to Deployment | (Implicitly met reliable design) |
| d. Stent Diameter | (Implicitly met reliable design) |
| e. Uniformity of Expansion | (Implicitly met reliable design) |
| Stent Integrity | Demonstrated reliability |
| Radial Force | Demonstrated reliability |
2. Sample size used for the test set and data provenance:
- Sample Size: Not explicitly stated for each test. The document mentions "tests" in plural, implying multiple units were tested, but no specific count is given.
- Data Provenance: Not specified, but generally, such tests are conducted internally by the manufacturer (Cook Incorporated) as part of their design verification and validation process in a controlled lab setting. It is not patient data.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- Not Applicable. This is a hardware medical device (stent). The "ground truth" for its performance is established through physical and mechanical testing against engineering specifications, not expert consensus on diagnostic images or clinical outcomes in the same way an AI/ML algorithm's ground truth would be established.
4. Adjudication method for the test set:
- Not Applicable. As this is a mechanical device, there is no expert adjudication of results in the context of diagnostic interpretation. Results are typically based on objective measurements and established engineering standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. This is not an AI/ML diagnostic device, so an MRMC study comparing human readers with and without AI assistance is not applicable.
6. If a standalone (i.e., algorithm-only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device. The concept of an "algorithm-only" performance does not apply.
7. The type of ground truth used:
- The "ground truth" for this device's performance is based on engineering specifications and performance metrics defined by the manufacturer and relevant industry standards for biliary stents (e.g., measurements of deployment accuracy, radial force, crimped profile).
8. The sample size for the training set:
- Not Applicable. This is a hardware medical device. There is no "training set" in the context of machine learning. The device design is based on engineering principles and materials science, not data-driven training.
9. How the ground truth for the training set was established:
- Not Applicable. As there is no training set for a machine learning model, this question does not apply. The design of the stent (e.g., Z-shaped segments, nitinol material) is based on established engineering and biomedical knowledge to achieve desired mechanical properties.
§ 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.