(99 days)
The ELEKTA Microdrive is intended to be used for accurate positioning of electrodes or other devices during stereotactic neurosurgery.
The ELEKTA Microdrive consists of a drive which is connected to the instrument holder of the stereotactic system, the MicroGun that holds the guide tubes and the Electrode holder where the electrodes are fixed. The guide tubes are inserted into the MicroGun and fixed with the lower end of the guidetubes 11 or 21 mm (two different lengths of guide tubes exist) in front of the target point. By moving a sledge with a fine-pitch screw the electrodes are advanced through the guide tubes into the brain. It is possible to position up to five electrodes simultaneously.
I'm sorry, but this document does not contain the information requested. The document is a 510(k) summary for the ELEKTA Microdrive, which is a stereotaxic instrument. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not include any information about acceptance criteria, study data, sample sizes, expert involvement, or ground truth establishment. It is a regulatory filing, not a scientific study report.
§ 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).