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The Stryker Video Ureteroscope is designed to be used with a Stryker video system, monitor and other accessories for endoscopic diagnosis and treatment within the urethra, bladder, ureter, and kidney.

The Stryker Video Ureteroscope is a flexible ureteroscope with a video sensor mounted on the distal tip, which provides the user visualization of the anatomy of the kidney and other urological structures. The bending section is controlled by the user with an articulation lever, to provide control of the position of the sensor. An integrated working channel provides the user the ability to introduce diagnostic or therapeutic instruments into the operative site. A light emitting diode is mounted internally in the handle and is connected to the light fibers that are integrated into the scope, which emit light from the distal tip of the scope, providing.illumination of anatomy. The Video Ureteroscope is powered and controlled by a console, which also provides video output to displays, capture devices, and other accessories.

This 510(k) summary describes the Stryker Video Ureteroscope and its equivalence to a predicate device. There is no information in the provided text regarding acceptance criteria for an AI/CADe (Computer-Assisted Detection/Diagnosis) device, nor any study proving the device meets such criteria. The document describes a traditional medical device (a video ureteroscope) and its performance testing as per design specifications and applicable standards, not AI-based performance metrics.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving an AI/CADe device meets them. The provided text discusses general device performance and regulatory compliance for a physical medical instrument.

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