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The KSEA 'Gelet' uretero-renoscopes are designed to view the ureter, and, using additional accessories, to perform various diagnostic and therapeutic procedures. The Alken motion control device attaches to an instrument channel to precisely guide the introduction of a laser fiber, electrode or small instrument into the patient.

The KSEA 'Gelet' uretero-renoscopes are semi-rigid endoscopes with graduated shafts and a remote eveniece. The Alken motion control device is an attachment to the irrigation/instrument channel to control the introduction and movement of accessories. Both devices are manually operated, reusable surgical devices. The body contact materials are chromium plated Monel 400®.

The provided text is a 510(k) summary for a medical device (semi-rigid ureteroscope and accessory). It focuses on establishing substantial equivalence to a predicate device, rather than detailing performance studies and acceptance criteria for a novel AI/software solution. Therefore, the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies cannot be extracted from this document.

The document indicates that:

• Device Identification: Karl Storz 'Gelet' Uretero-Renoscopes and Karl Storz Alken motion control device.
• Indication: To view the ureter and perform diagnostic and therapeutic procedures using accessories. The Alken device guides the introduction of instruments.
• Device Description: Semi-rigid endoscopes and an attachment for instrument channel control. Manually operated, reusable surgical devices.
• Substantial Equivalence: Claimed due to "basic features, design and intended uses are the same or similar" to predicate devices. Minor dimensional differences are stated to raise no new issues of safety and effectiveness and have no effect on performance, function, or intended use.

This type of submission typically bypasses the need for extensive clinical performance studies that establish acceptance criteria against specific metrics, as it relies on the known safety and efficacy of the predicate device. Therefore, the information requested in your numbered points is not present in this 510(k) summary.

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