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The WallFlex Biliary RX Stent System is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms and relief of malignant biliary obstruction prior to surgery.

The WallFlex Biliary RX Fully Covered Stent System RMV is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms, relief of malignant biliary obstruction prior to surgery and for indwell up to 12 months in the treatment of benign biliary strictures secondary to chronic pancreatitis.

The Epic Biliary Endoscopic Stent System is indicated for palliation of malignant neoplasms in the biliary tree.

The WallFlex™ Biliary RX Stent System is available in the following stent configurations: Uncovered, Fully Covered. The WallFlex Bliary RX Stent System consists of a self-expanding metal stent and a delivery system. The self-expanding metal stent consists of Platinum cored Nitinol wires wound together to form a cylinder including flares on both the proximal end and distal end.

WallFlex Fully Covered (FC) and Partially Covered (PC) Stents have a Permalume™ Coating, which is a translucent silicone polymer. The coating is used to reduce the potential for tumor in growth through the stent. The coating is used to reduce the potential for tumor in growth through the stent. The FC and PC stents have a retrieval loop for removal during the initial stent placement procedure, to be used in the event of incorrect placement.

The WallFlex Biliary RX Fully Covered Stent System RMV consist of a flexible delivery system preloaded with a self-expanding billiary metal stent. The stents are available in a fully covered configuration only, and have a Permalume™ Covering, which consists of a translucent silicone polymer, to reduce potential for tumor in growth through the stents also have a retrieval loop for removal during the initial stent placement procedure where the retrieval loop is used in the event of incorrect placement, or for removal following indwell up to 12 months.

The Epic "Billary Stent is a sterile laser cut sent composed of a nickel titanium alloy. The stents are available uncovered.

On both the proximal and distal ends of the stent, radiopaque markers increase visibility of the stent to aid in placement.

Since the provided text is a 510(k) summary for medical devices (biliary stents), it does not contain any information about acceptance criteria or a study proving that an AI/device meets acceptance criteria. This type of document is about demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing and comparison of technical characteristics, rather than through clinical studies with specific performance metrics and acceptance criteria for a novel algorithm's clinical performance.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on equivalence for physical medical devices, not on the performance of a diagnostic or assistive AI system.

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The WallFlex Biliary RX Stent System is in the palliative treatment of biliary strictures produced by malignant neoplasms, and relief of malignant biliary obstructions prior to surgery.

The WallFlex™ Biliary RX Stent System is an implantable biliary self-explaining metal stent that is pre-loaded onto a Delivery System with a working length of 194cm, which allows delivery of the stent into the Biliary system endoscopically. The self-expanding metal stent consists of Platinum cored Nitinol wires wound together to form a cylinder including flares on both the proximal and distal ends. WallFlex™ Biliary RX Stent is available uncovered, partially covered, or fully covered with a Permalume™ covering.

The Boston Scientific WallFlex™ Biliary RX Stent System is not an AI/ML device, therefore, the requested information regarding acceptance criteria and performance study details related to AI/ML is not applicable.

The provided FDA 510(k) summary (K223469) describes a medical device, a self-expanding metal stent used for palliative treatment of biliary strictures. The performance data section refers to non-clinical testing performed in accordance with FDA guidance documents for similar devices, specifically addressing:

• Metal Expandable Biliary Stents Premarket Notification (510(k)) Submissions
• Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol
• Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment

These types of tests typically evaluate mechanical properties, biocompatibility, and magnetic resonance compatibility, rather than AI/ML performance metrics.

Therefore, the requested information categories such as sample size for test sets, data provenance, expert qualifications for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set details are not relevant to this device's submission.

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The WallFlex™ Biliary RX Stents are indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms and relief of malignant biliary obstruction prior to surgery.

The WallFlexTM Biliary RX Stent System is an implantable biliary self-expanding metal stent that is pre-loaded onto a Delivery System with a working length of 194mm, which allows delivery of the stent into the Biliary system endoscopically. The self-expanding metal stent consists of Platinum cored Nitinol wires wound together to form a cylinder including flares on both the proximal end and distal end. The WallFlex "M Biliary RX Stent is available uncovered, partially covered, or fully covered with a Permalume 199 covering.

The provided text describes a 510(k) submission for an expanded indication for the WallFlex™ Biliary RX Stent System, not a study involving acceptance criteria and device performance metrics in the context of an AI/ML medical device.

Therefore, the requested information (acceptance criteria table, sample sizes, expert details, adjudication methods, MRMC study, standalone performance, training set details, and ground truth establishment) cannot be extracted from the provided text as it does not pertain to the evaluation of an AI/ML device.

The submission is for a medical device (a stent system) seeking an expanded indication for use, specifically for "relief of malignant biliary obstruction prior to surgery." The document explicitly states:

• "No performance data was required for this submission."
• "Boston Scientific used published clinical results of stents used for pre-operative biliary drainage. The conclusion from this review demonstrates that the WallFlex Biliary Stent System can be safely and effectively used as a relief of biliary obstruction prior to surgery."

This indicates that the submission relied on a review of existing literature and the technological equivalence to a predicate device (K122072), rather than new, primary performance data or a clinical study designed to meet specific acceptance criteria of the device itself.

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