(18 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 seqments, 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" Biljary Stent comes prefoaded 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 and 60 mm.
This device is a medical implant, and the provided text describes its 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than a study against a pre-defined acceptance criteria for diagnostic/AI performance. The information you requested, particularly regarding acceptance criteria for diagnostic performance, sample sizes for test/training sets, expert involvement, and comparative effectiveness studies, is not typically part of a 510(k) submission for this type of device (a biliary stent).
However, I can extract the relevant information pertaining to the device's functional performance testing as described in the submission.
Here is the information based on the provided text, heavily inferring where direct answers to your questions are not present due to the nature of the submission (device not AI/diagnostic):
1. Table of Acceptance Criteria (Inferred Functional Performance) and Reported Device Performance
| Acceptance Criteria Category (Inferred) | Specific Test | Device Performance (Reported as assurance of reliable design and performance) |
|---|---|---|
| Deployment | a. Profile | Assured reliable design and performance |
| b. Deployment Accuracy | Assured reliable design and performance | |
| c. Stent length and Change due to Deployment | Assured reliable design and performance | |
| d. Stent Diameter | Assured reliable design and performance | |
| e. Uniformity of Expansion | Assured reliable design and performance | |
| f. Stent Integrity | Assured reliable design and performance | |
| g. Ease of Deployment | Assured reliable design and performance | |
| Mechanical Properties | Radial Force | Assured reliable design and performance |
| Finite Element Analysis | Assured reliable design and performance | |
| Tensile Testing | Assured reliable design and performance |
Note: The submission states "The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a biliary stent." This implies that the device met the pre-defined acceptance criteria for each of these functional tests, without detailing the specific numerical thresholds for those criteria in this summary.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text.
- Data Provenance: Not applicable in the context of device functional testing described. These are laboratory/bench tests, not clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth, in the diagnostic sense, is not established for these functional device performance tests. These tests are based on engineering specifications and measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This concept pertains to expert review in diagnostic studies, not functional device testing.
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:
- No. This is a medical device (stent), not an AI/diagnostic software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a medical device (stent), not an AI/diagnostic software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the functional tests described, the "ground truth" would be the engineering specifications and established test methodologies (e.g., measuring stent diameter, deployment accuracy against a defined target, tensile strength against a known material property standard). It's based on physical measurements and material science, not clinical ground truth.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device. The design and manufacturing processes are likely informed by engineering principles and previous device designs, but there isn't a "training set" in the AI sense.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
§ 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.