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BrainLAB VectorVision® Fluoro3D is intended to be an intraoperative image guided 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 preoperative 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 long bone, or vertebra, can be identified relative to a CT, X-ray or MR based model of the anatomy.

Example procedures include but are not limited to:

Spinal Procedures:

Spinal implant procedures such as pedicle screw placement. -

VectorVision® Fluoro3D intends to enable "touchless" patient registration for operational planning and navigation in surgery. It allows using automatic registered intra-operatively acquired image modalities (e.g. volume data calculated from a set of x-ray images) processed by a VectorVision workstation.

The provided text is a 510(k) summary for the VectorVision® Fluoro3D device. It outlines the device's intention, substantial equivalence to predicate devices, and regulatory information. However, it does not contain a study or specific acceptance criteria with reported device performance metrics.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, nor can I provide information on sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as none of this information is present in the provided document.

The document primarily focuses on establishing substantial equivalence based on the device's functionality and its comparison to existing, cleared devices. It states that "The validation proves the safety and effectiveness of the information provided by BrainLAB in this 510 (k) application was found to be substantially equivalent with the predicate device VectorVision® (K983831), VectorVision® Spine Software (K981508), Vector Vision® (K010968)." This suggests that validation was performed, but the details of that validation (criteria, performance, study design) are not included in this summary.

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