(128 days)
The VisAR System is intended as an aid for precisely locating anatomical structures in either open or percutaneous spine procedures. VisAR is indicated for any medical condition in which the use of stereotaxic surgery may be appropriate, and where reference to at least one rigid anatomical structure, such as the spine or iliac crests, can be identified relative to CT imagery of the anatomy. This can include guidance for procedures, such as Posterior Pedicle Screw Placement in the thoracic and sacro-lumbar region.
VisAR displays a virtual screen for stereoscopic 3D images acquired from CT sources. It is intended to enable users to segment previously acquired 3D datasets, overlay, and register these 3D segmented datasets with the anatomy of the patient in order to support intraoperative analysis and guidance.
The virtual screen is indicated for displaying the virtual instrument location to the virtual anatomy to assist in visualization and trajectory planning for both open and percutaneous surgeries.
The VisAR system is an image-guided navigation system that is designed to assist surgeons in placing pedicle screws accurately, during open or percutaneous spinal surgery. The system consists of Novarad's immersive augmented reality software running on the Microsoft Hololens 2 headset, image visible ARTags (AprilTags), a pre-operative planning workstation and the Novarad PACS server. It uses optical tracking technology to co-localize the virtual 3D image datasets to the patient and displays to the surgeon the location of pre-operatively planned operative tracks and the tracked surgical instruments relative to the acquired intraoperative patient's scan, onto the surgical field. The 3D scanned image, along with tracking information, are projected to the surgeons' retina using a transparent near-eye display stereoscopic headset, allowing the surgeon to both look at the navigation data at the same time.
Here's a summary of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated Goal) | Reported Device Performance |
|---|---|
| System Level Accuracy: Mean 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).