(294 days)
The MagVenture TMS Atlas Neuro Navigation System is a neuronavigation system indicated for accurate positioning of the treatment coil of the MagVenture TMS Therapy system with respect to target brain regions based on data obtained from MRI measurements. Specifically, the MagVenture TMS Atlas Neuro Navigation System is indicated for use with the following MagVenture treatment coils manufactured by Tonica Elektronik A/S: C-B60, Cool-B70, Cool DB80, MCF-B65, MCF-B70, and C-B70.
The MagVenture TMS Atlas Neuro Navigation System (TMS Atlas system) combines MRI-based, 3-D visualization of cortical areas of the brain with non-invasive TMS in order to target brain areas accurately, and to locate the target for depression therapy. The TMS Atlas software is used to import a patient's MR image slices through standard DICOM communication protocols, and automatically generates an accurate 3-D model of the patient's head, and a custom automatic tissue segmentation routine to reveal anatomical structures of the brain surface in 3D.
The provided text describes the acceptance criteria and supporting studies for the MagVenture TMS Atlas Neuro Navigation System.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Study Type |
|---|---|---|---|
| Tracking System Accuracy | Static accuracy better than or equal to 1.4 mm RMS, 0.5 degrees RMS (accuracy of localization of tool) | 1.4 mm RMS, 0.5 degrees RMS (accuracy of localization of tool) | Tracking System Accuracy Test (from NDI reports) |
| System Accuracy (Navigation) | Navigation accuracy |
§ 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).