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The SCB/ConMed ESU Interface Module is an accessory to a Karl Storz-SCB control devices (SCB Interface Control, SCB Media Control or ACC Control) which allows for use of the third party device, ConMed ESU models 2450/5000. The ESU's are remote controlled surgical generators operated by a Karl Storz-SCB control device via the Karl Storz interface module.

The Karl Storz SCB/ConMed ESU Interface Module is an accessory to integrate the third party devices ConMed ESU models 2450/5000 units to a Karl Storz-SCB control device and permits remote control via the Storz SCB-RUI System.

I am sorry, but based on the provided document, I cannot fulfill your request. The document describes a 510(k) premarket notification for an "SCB/ConMed ESU Interface Module," which is an accessory to integrate third-party devices. This is a medical device, but it is not an AI/ML powered device.

The information you are asking for, such as acceptance criteria, sample sizes for test and training sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies, are typical requirements for evaluating the performance of AI/ML-powered medical devices. Since this device is an interface module and not an AI/ML algorithm, these types of performance evaluation metrics are not present in the provided documentation.

The document primarily focuses on demonstrating "substantial equivalence" to a predicate device, which is a regulatory pathway for non-AI/ML devices. Therefore, I cannot extract the AI/ML-specific information you've requested from this text.

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