(252 days)
The RIWOtrack Navigation System is intended to continuously display the position and orientation of RIWOspine surgical instruments relative to the anatomy in medical image data in either open or minimal invasive orthopedic procedures.
The use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the spine or pelvis, can be identified relative to images of the anatomy.
This can include spinal procedures, where the target point for the access to the access to the area of interest, is a rigid landmark, such as:
· Transforaminal procedure
• Interlaminar procedure
The RIWOtrack Navigation System is an image guided surgery system, visualizing instrument positions on intraoperative fluoroscopy images (AP and LAT) utilizing electromagnetic tracking technology. The positions of the instrument and of the patient localizer, both equipped with sensors, are localized within an electromagnetic field, generated by a field generator, called navigation sensor. The principle of navigation is based on electromagnetic spatial measuring of localizer element in a generated electromagnetic field. The display of navigation information requires an image-to-patient registration procedure. During registration procedure, the Navigation System determines the coordinate transformation between the physical position of the patient and the position of the patient in intraoperative scans by means of autodetection of x-ray marker of a device called MapperBridge. Thereafter, the spatial position of the instrument is displayed superimposed to the image data. The navigation information is updated with a rate of 15 to 45 Hz.
Here's a breakdown of the acceptance criteria and study information for the RIWOtrack Navigation System, based on the provided FDA 510(k) summary:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mean system level accuracy: Position 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).