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The KARL STORZ Flexible Uretero-Reno-Fiberscope is indicated for examination of the upper urinary tract including the ureter and kidneys and, using additional accessories, to perform various diagnostic and therapeutic procedures.

The optical component of the KARL STORZ flexible ureteroscope consists of:
• A light post connection with screw-on adapters for fiberoptic light cables.
• A fiber optic light conductor
• An optical image bundle behind an objective lens
• A flexible shaft housing
• A magnifying eyepiece with a focusing ring that rotates to adjust to the appropriate diopter correction for the user
• A reticle, or marker in the field of view, that indicates the 12 o'clock position as a point of reference

The insertable portion of the instrument is divided into a flexible shaft section and a deflection section. The features of the shaft include:
• A working channel that accepts flexible accessories at the proximal end and features a T-LUER Lock fitting for irrigation
• A deflection lever, for active distal tip deflection
• A proximal strain relief that connects the flexible shaft to the handpiece

The provided document is a 510(k) Summary for a medical device, the KARL STORZ Flexible Uretero-Reno-Fiberscope. It outlines the device's characteristics and compares it to predicate devices to demonstrate substantial equivalence.

However, the document states: "Clinical testing was not required to demonstrate the substantial equivalence to the predicate device. Non-clinical bench testing was sufficient to assess safety and effectiveness and to establish the substantial equivalence of the modifications."

This means that a study proving the device meets acceptance criteria in terms of clinical performance (human-in-the-loop, standalone algorithm performance, or using human experts for ground truth) was not conducted or submitted for this 510(k) clearance.

Therefore, it is not possible to provide the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided text.

The document focuses on demonstrating substantial equivalence through:

• Biocompatibility testing (ISO 10993)
• Reprocessing validation (AAMI ST91:2021, ANSI/AAMI/ISO 14937:2009, FDA Guidance Document Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling)
• Additional bench testing to meet design specifications, complying with IEC 60601-2-18:2009, IEC 62471:2006, and ISO 8600-5:2020.

These non-clinical tests were deemed sufficient for demonstrating the device's safety and effectiveness and its substantial equivalence to predicate devices for its intended use.

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