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The drill is intended to be used with an external drainage and monitoring system in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF, and to monitor ICP. The drill is intended for single use only.

Clinical Neuro Systems Interchangeable Bit Cranial Drill consists of various bit sizes used during a ventriculostomy procedure. The product includes a hand drill with variable chuck, a 0.156" (3.97mm) drill bit with depth guard, a 0.209" (5.31mm) drill bit with depth guard, and a 0.25" (6.35mm) drill bit with depth guard. The depth quard allows accurate, secure, and easy to use adjustment of cranial drill depth. Cranial drill depth is selected by setting the depth guard to the required distance. The Cranial Drill allows for access to the subarachnoid space or the lateral ventricles of the brain. The Cranial Drill is supplied sterile, double CSR wrapped in a Chevron pouch.

This document describes the marketing authorization for a medical device and, as such, does not contain information about the device's acceptance criteria, study design, or performance metrics in a way that aligns with your request for AI/algorithm performance. The information provided is for a cranial drill, which is a physical surgical tool, not an AI or software-based device.

Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text. The "Test Data" section in the input only shows that standard medical device tests (Sterility, Performance, Cytotoxicity, Comparative Evaluation) were performed and found "Acceptable" for regulatory approval, but it does not detail performance metrics, sample sizes, ground truth establishment, or human reader studies relevant to an AI/algorithm.

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