(207 days)
The ArchStent Biliary system is intended for use in the palliation of malignant neoplasms in the biliary tree
The ArchStent Biliary System is a 0.014" guidewire-compatible, rapid exchange (RX) balloonexpandable stent system. It consists of a stainless steel stent that can flare in the proximal segment and a dual balloon delivery catheter. Accessories include a 1.0 cc Syringe and a 10 cc Deflation Syringe.
The provided document is a 510(k) summary for the ArchStent Biliary System. It details the device description, intended use, and performance data from bench testing. However, it does not contain information related to software AI/ML performance, such as acceptance criteria for AI algorithms, clinical study design, sample sizes for test or training sets in an AI context, expert ground truth establishment, or multi-reader multi-case studies.
Therefore, I cannot extract the requested information regarding AI device performance.
The document describes material and mechanical bench testing for a physical medical device (biliary stent system), which falls under a different regulatory pathway and testing paradigm than AI/ML-driven software.
Here's a summary of the information that is present in relation to the device's performance data, but it's not related to AI:
F. Performance Data:
- Type of Testing: In-vitro performance bench tests.
- Tests Performed:
- Deployment Testing
- Compression Force Testing
- Dimensional Testing
- Corrosion Testing
- Balloon Performance Testing
- Stent Deformation Testing
- Tensile Strength Testing
- Testing Conditions: All testing was performed on sterile, finished devices per FDA guidance document "Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents," February 1998.
- Biocompatibility: Performed as suggested by ISO 10993 Guidelines, FDA General Program Memorandum No. G95-1, ODE Bluebook Memorandum, No. G95-1, and FDA guidance document "Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents," February 1998.
- Conclusions: All test results demonstrate that the materials, manufacturing process, and design of the ArchStent Biliary System meet the established specifications necessary for consistent performance according to its intended use and is biocompatible.
The following information fields from your request cannot be fulfilled from the provided text as they pertain to AI/ML device studies:
- A table of acceptance criteria and the reported device performance (for AI)
- Sample sized used for the test set and the data provenance (for AI)
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (for AI)
- Adjudication method (for AI)
- 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
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used (for AI)
- The sample size for the training set (for AI)
- How the ground truth for the training set was established (for AI)
§ 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.