(201 days)
BrainLAB VectorVision Spider is intended to be an intraoperative image guided localization system to enable open or percutaneous surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient 's images data being processed by a VectorVision Spider workstation. The system is indicated for any medical condition where a reference to a rigid anatomical structure, such as the skull, a long bone or vertebra can be identified relative to a CT, MR or X-ray based model of the anatomy.
BrainLAB VectorVision Spider is intended to be an intraoperative image guided localization system to enable open or percutaneous surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient 's images data being processed by a VectorVision Spider workstation.
The provided text is a 510(k) clearance letter from the FDA for a device called "Vector Vision2 (BrainLAB Navigation System)". This letter indicates regulatory clearance based on substantial equivalence to a predicate device, rather than providing a detailed technical study report with specific acceptance criteria and performance data.
Therefore, the input does not contain the information required to answer the questions regarding acceptance criteria, device performance, study details (sample size, data provenance, expert details, adjudication methods, MRMC study, standalone performance), or ground truth establishment.
The document is a regulatory approval letter and not a scientific or clinical 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).