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The Well Lead Ureteral Access Sheath is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract.

The Well Lead Ureteral Access Sheath is a single use sterile device, provides ureteral dilation and a continuous working channel for the introduction of endoscopes and instruments during ureteral access procedures. The Ureteral Access Sheath is comprised of three components: sheath, dilator and connector. The outer surface of the sheath has a hydrophilic coating. When activated, the hydrophilic feature allows for easier insertion and removal of the sheath. The sheath is offered in three French sizes: 10Fr, 12Fr and 14Fr, and range in length from 13cm (shortest) to 55cm (longest).

I am sorry, but the provided text is a 510(k) summary for a medical device (Well Lead Ureteral Access Sheath) and does not contain the specific information requested regarding an AI device's acceptance criteria and the study proving it meets those criteria.

The document focuses on the regulatory clearance process for a physical medical device, outlining its specifications, intended use, and substantial equivalence to predicate devices. It refers to performance testing for the physical device characteristics (e.g., attachment security, bending resistance, coefficients of friction, dimensions, biocompatibility), but not AI performance metrics like sensitivity, specificity, or reader improvement.

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