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The Cosgrove Depth Electrode Kit (CDEK) allows the user to place and secure epilepsy electrodes via a lateral orthogonal surgical approach or stereotactically using Radionics CRW and BRW Stereotactic Arc Systems which have been cleared through the FDA.

The CDEK Cosgrove Depth Electrode Kit addressed in this premarket notification has similar intended use and technological characteristics as accessories provided in the commercially available Radionics Todd-Wells Stereotaxic Guide (a pre-amendment device), the Radionics CRW and BRW Stereotactic Arc Systems, and Radionics Bipolar Forceps (a pre-amendment device).

The provided text describes a medical device, the Cosgrove Depth Electrode Kit (CDEK), and its intended use, but it does not contain information about acceptance criteria or a study proving the device meets said criteria in the way you've outlined for an AI/CAD system.

The document is a "Summary of Safety and Effectiveness" for a traditional medical device (a kit for electrode placement), focusing on its substantial equivalence to predicate devices and general safety instructions. It doesn't involve performance metrics like sensitivity, specificity, or reader studies that would be typical for an AI-powered diagnostic device.

Therefore, I cannot populate the requested table and answer the study-specific questions based on the provided input. The document discusses regulatory aspects and device characteristics, not performance evaluation data as would be generated for a software or AI-driven system.

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