(122 days)
The WallFlex Biliary RX Uncovered Stent system is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms.
The proposed WallFlex™ Biliary RX Uncovered Stent System consists of a selfexpanding metal stent and a delivery catheter. The proposed stent consists of Platinum cored Nitinol wires wound together to form a cylinder with both proximal and distal flares. The proposed stent is mounted onto a sheath delivery system. The groposed delivery system is a coaxial tubing assembly that constrains the stent onto the delivery catheter shaft until the stent is released by retracting the exterior tube.
The provided document describes a 510(k) premarket notification for the WallFlex™ Biliary RX Uncovered Stent System, where the device is demonstrated to be substantially equivalent to previously marketed predicate devices. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to demonstrating substantial equivalence based on comparative performance testing against predicate devices, rather than a clinical study with specific performance metrics for a novel AI device.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices (Wallstent Biliary Endoprosthesis (K000308, K993232, K982184, K964119, K925406) and Wallstent RX Biliary Endoprosthesis (K012752, K030107)) in technological characteristics. | The proposed WallFlex™ Biliary RX Uncovered Stent System has similar technological characteristics to the currently marketed Wallstent Biliary Endoprosthesis and Wallstent RX Biliary Endoprosthesis. |
| Performance equivalent to predicate devices in specified tests. | Comparative performance testing was completed, which included but was not limited to: Dimensional evaluation Radial force Deployment and reconstrainment force Bond integrity (The document explicitly states that these tests were performed to establish substantial equivalence with predicate devices.) |
| Indicated for the palliative treatment of biliary strictures produced by malignant neoplasms. | The device is indicated for this use. (This is an intended use statement, not a performance metric from a study demonstrating efficacy against acceptance criteria.) |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a clinical study with a "test set" in the sense of patient data. The "testing" referred to is comparative performance testing of the device itself (e.g., mechanical properties) in a laboratory setting, not on human subjects. Therefore, information about patient sample size, data provenance, or retrospective/prospective nature is not applicable here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the study described is not a clinical study involving the establishment of ground truth by medical experts.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
This information is not applicable as there is no "test set" in the context of clinical data requiring expert adjudication.
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
This document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it involve AI assistance. The device is a physical medical device (stent), not an AI algorithm.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable as the device is a physical medical device, not an AI algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context refers to the established functional and safety characteristics of the predicate devices. The WallFlex™ Biliary RX Uncovered Stent System demonstrated that its performance in various engineering tests was "substantially equivalent" to these established predicates. There is no mention of "expert consensus, pathology, or outcomes data" being used as ground truth for a clinical evaluation of this specific device's efficacy.
8. The Sample Size for the Training Set
This information is not applicable as the document describes engineering/performance testing of a physical device, not the training of an AI algorithm based on data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as the document describes engineering/performance testing of a physical device, not the training of an AI algorithm.
Summary of Device Acceptance and Study Type:
The acceptance criteria for the WallFlex™ Biliary RX Uncovered Stent System, as presented in the 510(k) summary, are primarily based on demonstrating substantial equivalence to existing, legally marketed predicate devices. The study conducted to meet these criteria was comparative performance testing in a laboratory setting, focusing on engineering and material characteristics rather than clinical performance or AI algorithm validation.
The testing included:
- Dimensional evaluation
- Radial force
- Deployment and reconstrainment force
- Bond integrity
These tests were performed to show that the new device performs similarly to the predicate devices, thereby establishing its substantial equivalence for its intended use in the palliative treatment of biliary strictures produced by malignant neoplasms. There is no information in the provided text about clinical trials, human subject data, or AI performance metrics.
§ 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.