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The MINOP® Disposable Introducer is indicated to obtain and maintain a temporary pathway into the ventricular system of the brain.

The purpose of the Minop® Disposable introducer is to obtain and maintain a temporary pathway to the ventricular system of the patient. The Minop® Disposable Introducer is designed to be split lengthwise and peeled down to the skull level of the patient, accommodating different depth requirements.

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I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA regarding a medical device called the "MINOP Disposable Introducer." This document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

The text focuses on the regulatory determination of substantial equivalence to a predicate device and general regulatory requirements. It does not include the type of technical study data you are asking for. Therefore, I cannot extract the requested information from this document.

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