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Intended Use: The NAVIGUS II MR Trajectory Guide is intended to provide stereotactic guidance for the placement and operation of instruments or devices during planning and operation of neurological procedures within the MRI environment and in conjunction with MR imaging. The Trajectory Guide is intended as an integral part of procedures that have traditionally used stereotactic methodology. These procedures include biopsies, catheter and electrode introduction. This device will provide accurate delivery of devices or instruments to target sites 3mm and larger.

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This document is a 510(k) clearance letter from the FDA for a medical device called the "Navigus II MR Trajectory Guide." It primarily focuses on the regulatory clearance process and does not contain the specific technical study details or acceptance criteria you've requested.

Therefore, I cannot provide the information you've asked for based solely on this document. The letter states that the device is "substantially equivalent" to a legally marketed predicate device, but it does not include the performance data, acceptance criteria, or study details that would typically be found in a 510(k) summary or within the actual submission that was reviewed by the FDA.

To answer your questions, I would need access to the full 510(k) submission document, specifically the sections detailing the performance data, testing protocols, and clinical or non-clinical studies.

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