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BrainLAB's Kolibri spine 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 Kolibri 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 of the spine 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 implant procedures such as pedicle screw placement Kyphoplasty and Vertebroplasty procedures Placement of temporary or permanent devices such as k-wires, needles, catheters or electrodes Thoracic spine surgery Tumor surgery on the spinal column and adjacent soft tissue Placement of acetabular and SI screws on the pelvis

Kolibri spine is a device that allows surgical planning and navigation. It links a surgical instrument, tracked by a passive marker sensor system to a virtual computer image, which is either based on patient's preoperative 3D data or based on online acquired intraoperative acquired 2D fluoro image(s) of a c-arm.

The device enables the navigation based on 3D data and/or based on acquired fluoro images (Fluoro only).

Based on 3D data, the procedure of linking the surgical instrument to the virtual computer image is achieved by performing certain registration methods.

Based on 2D fluoro images, the registration is done automatically by using the exact spatial position information of the intra-operatively acquired fluoro images.

After registration, the device assists the surgeon in performing certain surgical procedures as described in the indications for use.

The provided document is a 510(k) Summary for the BrainLAB Kolibri spine, an image-guided surgery system. It describes the device's intended use and substantial equivalence to predicate devices but does not contain information regarding specific acceptance criteria, a detailed study proving performance against such criteria, or the methodology (e.g., sample sizes, expert qualifications, ground truth establishment) for any such study.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide details on the study that proves the device meets acceptance criteria, as this information is not present in the provided text.

The document primarily focuses on the regulatory submission for clearance, outlining the device's description, intended use, and its substantial equivalence to previously cleared devices. It states that the device "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." However, it does not provide the specifics of this validation.

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