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The Neurorecovery™, Inc., Neurorecovery™ Comprehensive Intracranial Pressure Evaluation and Relief Kit (NRI CIPER™ Kit) is intended for single patient use for the measurement of intracranial pressures (ICP) and drainage of Cerebral Spinal Fluid (CSF). It is intended for short term management of patients with increased intracranial pressure.

The Neurorecovery" Comprehensive Intracranial Pressure Evaluation and Relief Kit (NRI CIPER™ Kit) is composed of many permanently connected components that incorporate a transducer for connection to an ICP monitoring device. The NRI CIPER™ Kit incorporates components of a cleared intracranial pressure monitoring device, an intracranial pressure transducer, and many components of the Neurorecovery™ Main Valve Assembly. The NRI CIPER™ Kit is designed to be used with the Neurorecovery " Main Valve Assembly. It is provided to the user sterile, non-pyrogenic (fluid path), single use, disposable, and not recommended for reuse of any kind.

The provided text is a 510(k) summary for the Neurorecovery™ Comprehensive Intracranial Pressure Evaluation and Relief Kit (NRI CIPER™ Kit). It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

The 510(k) summary primarily focuses on establishing substantial equivalence to legally marketed predicate devices (Medex, Inc. Intracranial Pressure Monitoring Device (K822864) and Medex, Inc. Transtar Intracranial Pressure Transducer (K020780)) based on "indications for use, design, materials, and operational characteristics." It explicitly states: "Neurorecovery™, Inc., believes that differences between devices are minor and raise no new issues of safety or effectiveness."

Therefore, I cannot populate the table or provide answers to the questions regarding performance studies, as this information is not present in the provided text. The document is a regulatory submission for premarket notification, not a clinical study report.

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