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The SURGERY PLANNING module is a tool for pre- and introoporative stereotactic surgery planning based on stereotactic systems Multiple graphical display functions and 3-dimensional views of anatomical structures offer an effective and efficient means of presenting the anatomical data for diagnostic and surgical planning. The module provides possibilities to combine and process intage data sets from CT, MRI, Angiographic, and other imaging sources. Computer-graphic simulation in various views of a chosen probe path can help prevent probe intersections with unwanted, critical structures or vessels. The surgeon can interactively change a probe path simulation through the image slices in the workstation with on-line calculation of the accompanying arc settings and graphical manipulation to aid in optimizing his approach. Its modular design makes possible adaption to the user's special requirements.

This module, hased on SURGERY PLANNING, is designed for computergraphic coloulation of isodoses from implantation of radioactive seeds, implanted at aven nositions within a turnor volume. The radioactive accoa are loaded into catheters that are implanted stereotactically. The computer software the isodose profiles in various views or in three dimensions prior to actual seed injuly not the catheters and the indivelling seeds can bo displayed in sceen contours, each perpendicular to the Uirection of the implanted catherers. The objective is to better tailor the dose distribution to the 3 dimensional volume of the turnor. The relevant implantation positions and other parameters can be printed out for a herdcopy documentation of what has been dulle.

The BRAINMAP module is a tool, which defines two and three-dimensional information about anatomical atructures of the human brain for pre- and intraveralive playming of stereotactic procedures.. These contours are defined and described by Tslairach/Tournoux and/or Schaltenbrand/Wahren based broin allasses. The user is provided with information about the various functional and anotomical areas of the brain. These positions of the structures have to be correlated with every patients brain data. The conclation is delined by a procedure defined by Talatach Tournoux. Using their prid system to divide the brain in porticular areas, the program will be able to provide maticliny data for different patient data. BrainMAP may be used alono or in conjunction with neurosurgcry, radiotheropy and radiosurgery planning systems.

The FUNCTIONAL PLANNING Module is a tool based on SURGERY PLANNING , which gives wor three rimensional online information of a stereotactical surgical instrument (clectrodco) for a neurosurgical functional treatment using a stereotactic arc. The user is provided with information by numerical results and by various displays and reconstruction planes based on patient images (CT, MRI, PET, SPECT) about the nasition and orientation relative to the patient of his surgical instrument to perfuring sumulation and treatment on brain structures or to a preplanned trajectory .

I he software is capable of displaying the trajectory and functional aroas of the brain baced on BRAINMAP online on the screen and recording the stimulations by storing positions of the electrodes.

The FUNCTIONAL PLANNING module is intended to be used with patients where measurement, stimulation and placement of electrodes in the brain (pallidotomy) are part of the stereotactic arc system Is useful for placing these electrodes or using the instruments during the treatment and in the planning phases of the functional treatment.

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I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a medical device called "@TARGET", which includes a description of its intended uses (Surgery Planning, Brachytherapy, Brainmap, and Functional Planning modules). However, it does not provide details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any comparative effectiveness studies. Therefore, I cannot generate the table or answer the specific questions about the study that proves the device meets the acceptance criteria.

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