(262 days)
neuroinspire is a stereotactic software application intended to allow trained clinicians to plan surgical trajectories for neurological procedures. neuroinspire a stereotactic region for this planning based on fiducial markers in CT images. neuroinspire reports specific surgical trajectories intended to be manually set on head frame systems validated for use with neuroinspire has been validated with the Leksell Stereotactic System Type G (comprising of head ring, head frame and CT Localizer). No other components of the Leksell Stereotactic System should be used. No other stereotactic system should be used. The user should consult Section 1.7 Accuracy of these Instructions for Use to assess if the accuracy of neuroinspire is suitable for their needs.
neuroinspire surgical planning software is an application that enables the viewing of medical images to support the image based neurosurgery. It may be used by neurosurgeons to reconstruct and display multiple image sets to facilitate 2D and 3D targeting and trajectory planning in relation to an intended neurological surgical procedure. It allows the neurosurgeon to download and integrate MRI and CT DICOM (digital imaging communication) images of a patient's brain onto a PC-based platform. The neurosurgeon can then virtually slice the brain into sections, zoom in for close-ups and rotate images in order to visualize and analyze the patient's brain prior to surgery.
neuroinspire has been validated with the Leksell Stereotactic System Type G (comprising of head ring, head frame and CT Localizer).
neuroinspire surgical planning software allows a neurosurgeon to:
- . load data acquired from an MRI scanner
- . load data acquired from a CT scanner;
- manually reconstruct target anatomy using multi-planer views; .
- calculate target coordinates;
- plan trajectories; ●
- print a surgical plan.
The information provided describes the acceptance criteria and the study conducted for the 'neuro | inspire' device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Maximum Euclidean Positional Error: |
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).