(160 days)
WallFlex® Biliary RX Partially Covered Stent System is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms.
The WallFlex Biliary RX Partially Covered Stent System consists of a self-expanding metal stent and a delivery catheter. The stent is partially covered with Permalume coating and includes a retrieval loop at the proximal end of the stent to aid in removal during the initial stent placement procedure. The stent is mounted onto a sheath delivery system. The 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 text is a 510(k) summary for the WallFlex® Biliary RX Partially Covered Stent System. It declares substantial equivalence to previously marketed devices and mentions "In-vitro, in-vivo, and clinical testing have been performed, and all components, subassemblies, and/or full devices met the required specifications for the completed tests." However, it does not provide specific details about the acceptance criteria, reported device performance metrics, sample sizes, ground truth establishment, expert qualifications, or study designs that would allow a comprehensive answer to your request.
Therefore, many of the requested fields cannot be filled from the provided document.
Here's a breakdown of what can and cannot be answered:
1. Table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not specified in the document. The text only states that "all components, subassemblies, and/or full devices met the required specifications for the completed tests." What those specifications were is not detailed.
- Reported Device Performance: Not specified in the document. No numerical performance metrics (e.g., success rates, complication rates, patency rates) are provided.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for any "test set" (clinical, in-vivo, or in-vitro).
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
- Ground Truth Establishment: Not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not specified.
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:
- MRMC Study: Not applicable. This document is for a medical device (stent), not an AI imaging product that would involve human readers interpreting images. Therefore, AI assistance to human readers is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone Performance: Not applicable. This is a medical device (stent), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Type of Ground Truth: Not specified. While "clinical testing" is mentioned, the nature of its ground truth is not detailed.
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable/specified. This is a medical device, not an AI model that undergoes "training."
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable.
Summary of available information:
The document states that the WallFlex® Biliary RX Partially Covered Stent System was subjected to "In-vitro, in-vivo, and clinical testing." The primary conclusion drawn from these tests, as presented in this 510(k) summary, is that the device is substantially equivalent to predicate devices (WallFlex Biliary RX Uncovered Stent System and WallStent™ RX Biliary Endoprosthesis). The basis of this substantial equivalence is that the new device shares the "same technological characteristics" and that "all components, subassemblies, and/or full devices met the required specifications for the completed tests."
However, the specific "acceptance criteria" and the "reported device performance" are not detailed in this public summary. The document does not contain the level of detail required to fill out most of the requested fields regarding study design, sample sizes, or ground truth establishment.
§ 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.