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Evolution® Duodenal Stent System- Uncovered: This device is used for palliative treatment of duodenal or gastric outlet obstruction and duodenal strictures caused by malignant neoplasms.

Evolution® Colonic Stent System- Uncovered: This device is used for palliative treatment of colonic obstruction or colonic strictures caused by malignant neoplasms, and to relieve large bowel obstruction prior to colectomy in patients with malignant strictures.

This flexible, self-expanding stent is constructed of nitinol wire. The stent diameter is increased at either end to help provide resistance to migration. The total length of the stent is indicated by radiopaque markers on the inner catheter. indicating the actual length of the stent at the nominal stent diameter.

Introduction System Description:

The stent is mounted on an inner catheter, which accepts a 0.035 inch wire guide and is constrained by an outer catheter. The handle allows for desheathing to deploy the stent and resheathing to recapture the stent during stent deployment.

The provided text is a 510(k) summary for the Evolution® Duodenal Stent System - Uncovered and Evolution® Colonic Stent System - Uncovered. It describes the device, its intended use, and compares it to predicate devices. The document highlights a material formulation change in the outer catheter and discusses performance testing conducted to support substantial equivalence.

However, the document does not provide the detailed information requested in the prompt regarding acceptance criteria, specific study results, sample sizes for test and training sets, expert qualifications, or ground truth establishment methods in the context of an AI-based device. This is because the device in question is a medical stent system, not an AI-powered diagnostic or assistive tool. Therefore, the requested information elements are not applicable to the content provided.

The document mainly focuses on demonstrating substantial equivalence to a predicate device through:

• Identical Indications for Use.
• Identical Technological Characteristics except for the outer catheter material.
• Biocompatibility testing for the new material.
• Performance testing related to the device's mechanical functions (deployment, recapture, tensile strength, dimensions).

Since this is not an AI device, I cannot fill out the requested fields.

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