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The Karl Storz Frimberger Varioguide is a manually operated surgical designed for placing of bilioduodenal drains (endoprostheses) during endoscopic procedures.

The KSEA Frimberger Varioguide is a manually operated, reusable surgical device consisting of a handle, guide, loader and Endo-pusher. The instruments are long enough to gain access to the surgical site. The body contact materials have a long history of use in medical devices and do not pose any new issues of safety and effectiveness.

This document is a 510(k) summary for a medical device (KSEA Varioguide). It does not contain information related to software performance, AI algorithms, or clinical study results that would typically include acceptance criteria and study data as outlined in your request.

The document describes the device, its intended use, and claims substantial equivalence to predicate devices. It does not report on any performance metrics like sensitivity, specificity, or accuracy that would be associated with AI or diagnostic device performance.

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