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This instrument is intended for use by qualified surgeons and is used for central operation, central display, automatic initial setting, and interlocking operation of KSEA endoscopic devices.

The Karl Storz SCBcom is a remote control unit for KSEA endoscopic equipment.

The provided text is a 510(k) summary for a remote control unit (Karl Storz SCBcom) and does not contain details about acceptance criteria, device performance, or a study proving that the device meets acceptance criteria.

The document focuses on the device's indications for use, description, and a claim of substantial equivalence to a predicate device based on similar basic features and intended uses. It explicitly states that "The minor differences between the Karl Storz SCBcom and the predicate device raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices." This implies that extensive performance studies with acceptance criteria might not have been deemed necessary due to its nature as a remote control and its substantial equivalence claim.

Therefore, I cannot provide the requested information.

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