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BrainLAB VectorVision trauma is intended to be a pre- and intraoperative image quided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's pre- or intraoperative image data being processed by a VectorVision workstation. The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, a bone structure like tubular bones, pelvic, calcaneus and talus, or vertebra, can be identified relative to a CT, fluoroscopic, X-ray or MR based model of the anatomy.

Example procedures include but are not limited to:

Spinal procedures and spinal implant procedures such as pedicle screw placement.

Pelvis and acetabular fracture treatment such as screw placement or illo-sacral screw fixation.

Fracture treatment procedures, such as intramedullary nailing or screwing or external fixation procedures in the tubular bones.

BrainLAB VectorVision trauma is intended to enable operational navigation in spinal, orthopedic and traumatologic surgery. It links a surgical instrument, tracked by flexible passive markers to virtual computer image space on a patient's intraoperative image data being processed by a VectorVision workstation.

VectorVision trauma allows navigation of intraoperatively acquired images considering patient's movement in correlation to calibrated surgical instruments. This allows implant positioning, screw placement and bone reduction in different views and reduces the need for treatments under permanent fluoroscopic radiation.

The provided text is a 510(k) summary for the VectorVision trauma device. It lacks detailed information about specific acceptance criteria and a structured study demonstrating the device's performance against those criteria. The provided text states "VectorVision trauma has been verified and validated according to BrainLAB's procedures for product design and development. The validation proves the safety and effectiveness of the system." This suggests that internal verification and validation studies were conducted, but the specifics are not included in this document.

Therefore, I cannot extract the information required for the table and other detailed questions from the provided text. The document focuses on the regulatory submission and substantial equivalence to a predicate device rather than presenting a performance study report.

If you have a document that details the specific verification and validation study results, I would be able to answer your request.

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