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The Parenchymal Bolt Pressure Monitoring Kit is indicated for use on patients that require continuous intracranial pressure monitoring.

This device should only be used by a physician or qualified personnel under the direction of a physician.

Care must be taken to ensure compliance with the manufacturer's Directions for Use.

Prescription Use Only (Per 21 CFR 801.109)

Parenchymal Bolt Pressure Monitoring Kit

This document is a 510(k) clearance letter from the FDA for a medical device called the "Parenchymal Bolt Pressure Monitoring Kit." It does not contain information about acceptance criteria, device performance studies, or AI/software validation. Therefore, I cannot extract the requested information.

The document primarily states that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory requirements. It clarifies the device's intended use but does not provide technical specifications or study details.

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