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Intended Use: The Navigus Trajectory Guide Biopsy Kit is intended to provide stereotactic guidance for the placement of a brain biopsy needle in conjunction with the use of a MRI and/or CT imaging.

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This document is a 510(k) clearance letter from the FDA for a medical device called the "Navigus Trajectory Guide Biopsy Kit." It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria.

Here's why and what's missing:

• Acceptance Criteria & Performance: The document only lists the device's trade/device name, regulation number, regulatory class, product code, and indications for use. It does not provide specific performance metrics (e.g., accuracy, precision, success rates) or the numerical acceptance criteria for those metrics.
• Study Details: There is no mention of any specific study conducted to validate the device's performance. All the requested information about sample sizes, data provenance, expert qualifications, ground truth, MRMC studies, or standalone performance is absent.
• Purpose of Document: This is a regulatory clearance letter, not a scientific study report or a summary of performance data. Its purpose is to officially state that the device can be marketed in the U.S. because it's deemed "substantially equivalent" to existing devices, implying that detailed performance data was submitted separately in the 510(k) application, but it's not present in this letter.

Therefore, I cannot populate the table or answer the specific questions based solely on the provided text.

To answer your request, I would need access to the actual 510(k) submission document or a summary of the performance studies conducted by Image-Guided Neurologics, Inc. for the Navigus Trajectory Guide Biopsy Kit.

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