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The Intended Purpose of the NaviNetics D1 Stereotactic System is target localization and fixation of the patient head in a coordinate system in order to perform stereotactic neurosurgical procedures, for example; deep brain stimulation, lesioning, biopsies, targeted injections, aspirations and minimal invasive tumor treatments.

The NaviNetics Reusable Stereotactic System is a device used for minimally invasive neurosurgical procedures. During image acquisition and treatment, the system's Skull Anchor Key ("Key") achieves reduced weight and patient invasiveness versus common stereotactic head frames that travel extensively around the patient's head and are restrictive to the airway access when positioned. The system consists of a Key that is affixed to the patient's skull with three titanium stand-off pins and four bone anchor screws. The Key serves as the common attachment platform for the Stereotactic Positioner and MRI and CT localizers. The system is based on established stereotactic center-of-arc principles with compatible instruments. These instruments rely on the active working length of 150 mm (arc radius) with stops and guide holders to ensure proper trajectory angle to the brain target. The two degrees of freedom of the arc-quadrant, the Arc and Collar angles, can be manipulated allowing the target from a multitude of directions. Linear adjustments can move the ar-quadrant, medial/ateral (Y), and superior/inferior (Z) to bring the focus to the surgical target. The output of surgical planning software provides the target coordinates (X, Y, Z) and the surgical trajectory (CT, AT) which dictate the settings of the stereotactic device.

I apologize, but the provided text from the FDA 510(k) K231392 document does not contain the specific acceptance criteria, corresponding device performance results, or details of a study that proves the device meets those criteria.

The document is a clearance letter from the FDA stating that the NaviNetics Reusable Stereotactic System (NN1000) is substantially equivalent to a predicate device (K210700). It focuses on the regulatory aspects of the device, its intended use, and a brief description of its features.

While it mentions "performance testing presented demonstrates the design changes... are substantially equivalent," it does not provide the results of that performance testing. It also states "There are no technological differences in design, material, chemical composition principle or energy source as shown on the Substantial Equivalence table from the predicate to the subject device, with one minor exception that does not affect device performance, accuracy or effectiveness. The previous working X, Y, and Z axis of 100, 100 is now slightly adjusted to 100, 105, 96." This paragraph indicates a minor adjustment in working axes, but again, no detailed performance data against specific acceptance criteria is given.

Therefore, I cannot fulfill your request for the table of acceptance criteria, device performance, sample sizes, data provenance, expert details, adjudication methods, MRMC study information, standalone performance, ground truth types, or training set details, as this information is not present in the provided text.

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