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The MDT Navigable Brain Biopsy Cannula is for use in stereotaxic biopsy of cranial tissue. The MDT Navigable Brain Biopsy Cannula is a pre-sterilized, single-use, sidecutting cannula where the cutting action is achieved by rotation of an inner cannula within an outer cannula. The device is compatible with Medtronic's StealthStation® Image Guided Surgery System.

The MDT Navigable Brain Biopsy Cannula contains a calibrated biopsy cannula that is used with a compatible image guided surgery navigation system in stereotaxic biopsy of cranial tissue. The device is compatible with Medtronic's StealthStation® Image Guided Surgery System. Like the predicate devices, both devices are pre-sterilized, single-use, stainless steel devices and use a side-cutting cannula where the cutting action is achieved by rotation of an inner cannula within an outer cannula.

The MDT Navigable Brain Biopsy Cannula components include a navigable biopsy cannula, a biopsy cannula stop with screw, a stop adjustment tool and an aspiration tube.

I apologize, but this document does not contain the specific information required to complete your request. The document is a 510(k) premarket notification acceptance letter and summary for a medical device (MDT Navigable Brain Biopsy Cannula).

While it mentions "performance testing" and "bench testing" were conducted, and that the device performs "comparably to the predicate device," it does not provide specific acceptance criteria, reported device performance metrics, or details about the study design (e.g., sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types for training or test sets, or training set sample sizes).

The document's primary focus is to establish substantial equivalence to a predicate device based on similar intended use and technological characteristics, not to detail the clinical trial or performance study's methodology or outcomes in the way you've requested.

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