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The BrainLAB Kolibri IGS System is intended to be an intraoperative image guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a magnetic sensor system or a passive marker sensor system to a virtual computer image space on a patient's preoperative diagnostic image data set being processed by the Kolibri computer 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 image quided cranial surgery procedures include but are not limited to:

1. Tumor resections
2. Skull base surgery
3. Cranial biopsies
4. Craniotomies/Craniectomies

Example image guided ENT surgery procedures include, but are not limited to:

1. Transphenoidal procedures
2. Maxillary antrostomies
3. Ethmoidectomies.
4. Sphenoidotomies./sphenoid explorations,
5. Turbinate resections
6. Frontal sinusotomies
7. Intranasal procedures

The Kolibri Image Guidance System is based on a portable hardware platform with integrated touch screen monitor. 3D tracking system controller and computer workstation. The navigation software won't be installed on the system hard disk but will be delivered on "memory modules that will be externally plugged into the system platform according to the current intended kind of surgery. The localization of patient position and surgical tools within the operating field will be performed by a magnetic or optical 3D localization system. All patient data needed for the image quided surgery will be transferred via the hospital LAN network or external media drives to the Kolibri workstation. Once the patient data is transferred to the Kolibri system, the application software automatically starts with the patient registration procedure. The user may perform the patient to 3D data registration either by using anatomical landmarks, fiducial markers or surface matching. The patient registration will be performed by use of a magnetic or optically tracked registration pointer. The surgeon can control all software functions of the Kollbri navigation system via touch screen. Therefore the monitor of the Kolibri navigation system will be draped with a sterile drape.

The provided text is a 510(k) Summary for the BrainLAB Kolibri Image Guided Surgery System. It describes the device, its indications for use, and a statement of substantial equivalence to predicate devices. However, this document does not contain the specific details about acceptance criteria, reported device performance against those criteria, or a detailed study description as requested.

It states: "The Kolibri™ Image Guides Surgery System incl. application software for Cranial and ENT applications 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 is a general statement indicating that testing was performed, but it does not provide the specifics of that testing.

Therefore, I cannot extract the requested information from this document. To fulfill the request, a detailed performance validation report or similar study document would be needed.

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