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The KARL STORZ OR1™ SCB CONTROL provides central control of compatible medical equipment in the operating room during diagnostic and therapeutic procedures.

The KARL STORZ OR1™ SCB CONTROL is a central control unit which provides a single point of contact in the operating room for centralized control of various medical devices in sterile and non-sterile areas during diagnostic and therapeutic procedures. The system consists of KARL STORZ OR1™ SCB CONTROL software run on a dedicated KARL STORZ OR1™ SCB CONTROL hardware platform (Model Number: WU300) which connects to a touch-sensitive LCD monitor (Model Number: WM100 or WM101).

The user interface enables central display and control of multiple parameters for KARL STORZ and third-party devices connected via SCB serial cable or ethernet cable to the KARL STORZ OR1™ SCB CONTROL hardware CPU. The equipment controls can be operated via sterile input on the touchscreen monitor with the use of a sterile disposable cover. Outside the sterile area a keyboard or mouse can optionally be used.

The provided document is a 510(k) Summary for the KARL STORZ OR1™ SCB CONTROL. It is a control unit for medical equipment in an operating room and does not involve AI or diagnostic capability. Therefore, it does not contain the information required to answer the questions about acceptance criteria, study details, ground truth, or MRMC studies for an AI-powered device.

The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data (electrical safety, EMC, software lifecycle, V&V testing) and does not present acceptance criteria or detailed study results in the context of diagnostic accuracy or AI performance.

Therefore, I cannot provide the requested information based on the given document.

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