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The ConvertX Biliary Stent System with releasable drainage catheter is delivered percutaneously and is intended for internal drainage of the bile ducts, for splinting of the bile ducts during healing, or for providing bile duct patency in a stricture or past a stone while maintaining external access to the stent, as well as providing external drainage. For patients for whom external drainage is not, or no longer desirable, the releasable drainage catheter may be removed, leaving the stent to provide internal drainage from the bile duct to the duodenum.

The ConvertX Biliary Stent System is a sterile, single-use non-vascular interventional device inserted using percutaneous access techniques to re-establish internal drainage and is intended for internal drainage of the bile ducts, for splinting of the bile ducts during healing, or for providing bile duct patency in a stricture or past a stone. The ConvertX Biliary System allows for external drainage and access as needed.

The ConvertX Biliary Stent System has two primary components: a double pigtail Biliary Stent and a Releasable Drainage Catheter with Hub.

The ConvertX Biliary Stent System is a single lumen device that has a detachable Biliary Stent with proximal and distal loops (pigtails). Both proximal and distal loops (pigtails) contain drainage holes. The proximal pigtail forms in the bile duct, while the distal pigtail forms in the duodenum. The distal pigtail has a tapered, atraumatic tip. Drainage can occur internally (from the bile duct to the duodenum) or externally (from the bile duct to the outside of the patient). A suture ("Loop Suture") is threaded through the proximal pigtail enabling the pigtail, straightened for delivery, to be closed in the bile duct.

The ConvertX Biliary Stent System's Hub has three ports which are used for both ends of the Loop Suture, external drainage of bile and the release wire. Ends of the Loop Suture and the Release Wire are connected to separate pull tabs within the Hub. The Releasable Drainage Catheter and Loop Suture may be detached from the Biliary Stent when external drainage is no longer necessary, leaving the stent in place. While still attached, the Releasable Drainage Catheter may be used to withdraw the Biliary Stent. The ConvertX Biliary Stent System is radiopaque throughout its length and has a marker on the stent between junction and proximal loop

The ConvertX Biliary Stent System is comprised of the following functional components:

• . Biliary Stent
• . Releasable Drainage Catheter with Hub

The ConvertX Biliary Stent System is supplied with the following accessories:

• . Metal Stiffening Cannula
• . Luer Cap
• . Plastic Stiffening Cannula
• . Loop Straightener

This document is a 510(k) summary for the BrightWater Medical ConvertX Biliary Stent System. It details the device's characteristics, intended use, and a comparison to predicate devices, along with a summary of non-clinical testing.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The document summarizes the "Summary of Non-Clinical Testing" which involved various tests based on applicable ASTM, ISO, and FDA guidance documents. The conclusion states, "The Convert X Biliary Stent System, including its packaging, met the predetermined acceptance criteria. No new safety or performance issues were raised during testing." This collective non-clinical testing served as the study proving the device met the acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the exact sample sizes (number of units tested) for each non-clinical test. It only lists the types of tests performed. The provenance of the data is not mentioned (e.g., country of origin, retrospective or prospective). This information is typically found in the full test reports, which are not included in this summary.

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 section is not applicable to the provided document. The listed tests are non-clinical (engineering, material, and simulated use testing), which do not involve expert interpretation or ground truth establishment by medical professionals in the context of diagnostic performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is not applicable to the provided document, as it describes non-clinical performance testing rather than studies involving expert adjudication of clinical outcomes or images.

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 section is not applicable. The document describes a medical device (a biliary stent system), not an AI-powered diagnostic tool, and therefore no MRMC study or AI-related effectiveness analysis was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This section is not applicable. The device is a physical medical stent system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For non-clinical testing, the "ground truth" or reference standard would be the validated testing methods and specifications defined in the relevant ASTM, ISO standards, and FDA guidance documents. For example, for tensile strength, the ground truth would be the specified force limits the device must withstand. For biocompatibility, it would be compliance with ISO 10993 requirements based on biological assays.

8. The sample size for the training set

This section is not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The testing described is for a physical medical device.

9. How the ground truth for the training set was established

This section is not applicable for the reasons stated in point 8.

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