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The Storz Communication Bus/ValleyLabs Force FX Control is an interface control box between the SCB computer and the electrosurgical generator. It contains software to display ValleyLab Force FX electrosurgical generator's control parameters on a SCB computer and screen. The Interface Unit serves as a connector box from the Force FX unit to the SCB compatible computer. The unit's software does not perform calculations. It only relays Force FX functions and controls on the SCB monitor for the surgeon's convenient control.

The Karl Storz SCB/ValleyLab Force FX Control connects a Storz Communication Bus computer to the ValleyLab Force FX electrosurgical generator. It enables the SCB computer to display and control the FX's functions.

The provided text describes a 510(k) premarket notification for a medical device and its clearance by the FDA. However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

The document is a regulatory submission for a device labeled "SCB/ValleyLab Force FX Interface Unit" and details its intended use, device description, and substantial equivalence to a predicate device. It confirms the FDA's clearance (K041912) for marketing.

Therefore, I cannot provide the requested information, which typically would be found in a clinical study report or a detailed performance validation section of a 510(k) submission.

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