(15 days)
The Cook Zilver® 518 TM Biliary Stent is indicated for use in palliation of malignant neoplasms in the biliary tree.
The Zilver® 518™ Biliary Stent with a diameter of 10 mm is a self-expanding, nitinol stent designed for superior 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® 518" Billary Stent, along with radiopaque markers on the delivery system, allow precise positioning of the stent's interconnected Zshaped seqments also keep foreshortening to a minimum.
The Zilver® 518" Biliary Stent comes preloaded in a 5 French delivery system. The stent is deployed with the use of a simple hand held device. The stent is currently available in unrestrained outer diameters of 4, 5, 6, 7, 8, and 9mm and in lengths of 20, 30, 40, 50 and 60 mm. The 10 mm diameter stent is an addition to this product line.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Zilver® 518™ Biliary Stent.
It's important to note that this document is a 510(k) summary for a medical device (stent), not a diagnostic AI/ML device. Therefore, the concepts of "experts establishing ground truth," "adjudication methods," "MRMC studies," "standalone algorithms," "training sets," and "data provenance" (in the context of clinical images/data for AI) are not directly applicable to this type of device submission. Instead, the "acceptance criteria" here refer to engineering and performance specifications, and the "study" is a series of mechanical and physical tests demonstrating these specifications are met.
Device: Zilver® 518™ Biliary Stent
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly list numerical acceptance criteria with corresponding numerical performance results in a table format. However, it indicates the types of tests performed to assure reliable design and performance. The "performance" is implicitly stated as having "conformance to the requirements for its use as a biliary stent."
| Acceptance Criteria Category (Implied) | Reported Device Performance (Implied) |
|---|---|
| Deployment Characteristics | |
| - Profile | Conforms to specified requirements for safe and effective deployment |
| - Deployment Accuracy | Achieves precise positioning |
| - Stent length and Change due to Deployment | Minimizes foreshortening; maintains specified length post-deployment |
| - Stent Diameter | Achieves specified diameter upon deployment |
| - Uniformity of Expansion | Provides circumferential scaffolding throughout the stent's length |
| - Stent Integrity | Maintained during and after deployment |
| - Ease of Deployment | Deployed with a simple handheld device |
| Mechanical Properties | |
| - Radial Force | Provides superior radial strength |
| - Longitudinal Flexibility | Achieves optimal longitudinal flexibility |
| Structural Integrity | |
| - Finite Element Analysis | Demonstrated reliable design and performance under specified parameters |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify the exact number of stents or test iterations used for each test. It refers to "the Zilver® 518™ Biliary Stent was subjected to the following tests."
- Data Provenance: Not applicable in the context of clinical data for AI. These are laboratory/bench tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. "Ground truth" for this device is established by engineering specifications, physical measurements, and possibly simulated use, not by clinical expert consensus on interpreting images or patient conditions.
4. Adjudication method for the test set
Not applicable. This concept applies to expert review of clinical cases, not mechanical 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
Not applicable. This is a medical device (stent), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (stent), not an AI algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance is based on engineering specifications and physical-mechanical measurements. For example, the "ground truth" for radial force would be a specific predefined value or range that the stent must demonstrate in a laboratory setting. Similarly, for deployment accuracy, the "ground truth" would be the measured deviation from the intended deployment location.
8. The sample size for the training set
Not applicable. This concept applies to AI/ML models. For medical devices, there isn't a "training set" in the computational sense, but rather a design and development process that involves iterative testing and refinement.
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.