(56 days)
The Zilver® 518™ Biliary Stent is indicated for use in palliation of malignant neoplasms in the biliary tree.
The Zilver® 518 " Biliary Stent 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 " Biliary Stent, along with radiopague markers on the delivery system, allow precise positioninq of the stent. The stent's interconnected Z-shaped segments 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 available in unrestrained outer diameters of 4, 5, 6, 7, 8, and 9 mm and in lengths of 20, 30, 40, 50 and 60 mm.
Here's an analysis of the provided text regarding the Zilver® 518™ Biliary Stent, focusing on acceptance criteria and study details.
Based solely on the provided text, the document primarily describes the device, its intended use, and substantial equivalence to predicate devices, along with the types of tests performed. It does not provide specific acceptance criteria values or detailed performance results in the format typically requested for AI/device performance studies. The document is a 510(k) summary for a medical device approval, which focuses on demonstrating substantial equivalence, and not on detailed performance metrics as would be found in a clinical trial report.
Therefore, many of the requested fields cannot be filled with specific data from this document. I will extract what is present and explicitly state when information is not available.
Description of Acceptance Criteria and Study:
The Zilver® 518™ Biliary Stent was subjected to a series of tests to assure reliable design and performance. These tests were comprised of:
- Deployment:
- Profile
- Deployment Accuracy
- Stent length and Change due to Deployment
- Stent Diameter
- Uniformity of expansion
- Stent Integrity
- Ease of Deployment
- Radial Force
- Finite Element Analysis
- Biocompatibility - ISO 10993-1
The document states that "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." However, the specific quantitative acceptance criteria (e.g., "Deployment Accuracy must be within X mm") and the reported device performance metrics (e.g., "Deployment Accuracy was Y mm") are not detailed in this summary.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Metric (as implied) | Acceptance Criteria (Specific Value/Range) | Reported Device Performance (Specific Value/Range) |
|---|---|---|---|
| Deployment | Profile | Not specified in document | Not specified in document |
| Deployment Accuracy | Not specified in document | Not specified in document | |
| Stent length change | Not specified in document | Not specified in document | |
| Stent Diameter | Not specified in document | Not specified in document | |
| Uniformity of expansion | Not specified in document | Not specified in document | |
| Stent Integrity | Not specified in document | Not specified in document | |
| Ease of Deployment | Not specified in document | Not specified in document | |
| Mechanical Properties | Radial Force | Not specified in document | Not specified in document |
| Simulation | Finite Element Analysis | Not specified in document | Not specified in document |
| Biocompatibility | ISO 10993-1 Compliance | Compliance with ISO 10993-1 standards | Device was subjected to and presumably met, as approval was granted. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the document. The tests listed are primarily bench/engineering tests, and the "sample size" would refer to the number of stents or components tested under each condition. This information is not provided.
- Data Provenance: Not specified. As these are bench tests for a medical device manufacturer (Cook Incorporated, Bloomington, Indiana, USA), it can be inferred the tests were likely conducted internally or by contracted labs, presumably within the US or a region adhering to similar standards. The data is likely prospective for these specific tests as they were performed to support the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This question is more applicable to clinical studies or studies involving human interpretation (e.g., imaging devices). The listed tests are primarily physical and chemical performance tests of the device itself. Therefore, "ground truth" would be established by validated test methodologies and instrument calibration, not by human expert consensus in the typical sense.
- The "experts" would be the engineers, scientists, and technicians performing and validating the tests, but no specific number or qualifications are provided here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable to the types of engineering and laboratory tests described. Adjudication methods are typically used in clinical studies or human-reader performance evaluations to resolve discrepancies in diagnoses or assessments.
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. An MRMC comparative effectiveness study was not done. This document describes the approval of a physical medical device (a stent), not an AI algorithm or an imaging diagnostic tool that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This is not an algorithm, but a physical medical device. Therefore, a standalone algorithm performance study is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the physical and chemical tests listed, the "ground truth" is based on objective measurements obtained from validated testing equipment and adherence to relevant industry standards (e.g., ISO 10993-1 for biocompatibility). It is not pathology, outcomes data, or expert consensus in a clinical diagnostic sense. For example, stent length change would be measured directly, and the true value is the measured value from the test instrument.
8. The sample size for the training set
- Not applicable. This document describes the approval of a physical medical device, not an algorithm that requires a training set. The device design and presumably iterative testing inform product development, but this is not analogous to an algorithm's training set.
9. How the ground truth for the training set was established
- Not applicable. As a training set is not relevant to this type of device approval, the establishment of its ground truth is also not applicable.
§ 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.