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The BrainLAB VectorVision Frameless Biopsy System 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:

Cranial Procedures: Cranial biopsies. Tumor resections. Craniotomies/ Craniectomies. Skull base procedures. Thalamotomies/ Pallidotomies.

Spinal Procedures: Spinal implant procedures such as pedicle screw placement.

ENT Procedures: Transphenoidal procedures. Intranasal procedures. Sinus procedures, such as Maximillary antrostomies, Ethmoidectomies, Sphenoidotomies/Sphenoid explorations, Turbinate resections and Frontal sinusotomies

The VectorVision Frameless Biopsy System contains features to improve the support and guidance of surgical instruments. A multiarticulated arm facilitates the use of miscellaneous instruments for serial approaches along a determined trajectory to a specific target as well as the guidance of a single instrument to multiple targets along the same trajectory. Combined with the IGS features of VectorVision's software, the determination and repeated locating of trajectories is considerably simplified. By mechanical support, the degrees of freedom of the instrument can be limited either to zero or to one, thus giving the surgeon's hand mechanical support for increased stability, alleviating the surgeon's task of holding or inserting instruments and enhancing the efficiency of the surgery.

This 510(k) summary describes a modification to the VectorVision Frameless Biopsy System, a medical device designed for image-guided surgery. However, the provided text does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or details regarding performance metrics, sample sizes for test or training sets, ground truth establishment, expert involvement, or comparative effectiveness studies.

The document details the device's intended use and substantial equivalence to previously cleared devices. It states:

• Product: VectorVision Frameless Biopsy System
• Manufacturer: BrainLAB AG
• Indications for Use: 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 (CT, X-ray, or MR). It is indicated for medical conditions where stereotactic surgery is appropriate and a reference to a rigid anatomical structure (skull, long bone, vertebra) can be identified. Examples include cranial (biopsies, tumor resections), spinal (pedicle screw placement), and ENT procedures.
• Modification: The new features are aimed at improving support and guidance of surgical instruments. A multiarticulated arm facilitates the use of various instruments for serial approaches or guiding a single instrument to multiple targets along the same trajectory. This, combined with existing IGS features, simplifies trajectory determination and locating. Mechanical support can limit instrument degrees of freedom, providing stability and alleviating the surgeon's task.
• Substantial Equivalence: The device was found substantially equivalent to BrainLAB's VectorVision2 System (K983831, K003589).

Therefore, based solely on the provided text, I cannot complete the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or expert involvement. The 510(k) summary focuses on the device's intended use and its substantial equivalence determination, rather than detailed performance study results against predefined acceptance criteria.

To provide the requested information, a separate performance study report or a more detailed section within the 510(k) describing validation testing would be necessary.

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