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**Stealth™ Spine Clamps** When used with Medtronic computer assisted surgery systems, defined as including the Stealth™ System, the following indications of use are applicable: - The spine referencing devices are intended to provide rigid fixation between patient and patient reference frame for the duration of the surgery. The devices are intended to be reusable. - The navigated instruments are specifically designed for use with Medtronic computer-assisted surgery systems, which are indicated for any medical condition in which the use of stereotactic surgery may be appropriate or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. - The Stealth™ spine clamps are indicated for skeletally mature patients. **ModuLeX™ Shank Mounts** When used with Medtronic computer assisted surgery systems, defined as including the Stealth™ System, the following indications of use are applicable: - The spine referencing devices are intended to provide rigid fixation between patient and patient reference frame for the duration of the surgery. The devices are intended to be reusable. - The navigated instruments are specifically designed for use with Medtronic computer assisted surgery systems, which are indicated for any medical condition in which the use of stereotactic surgery may be appropriate or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. - The ModuLeX™ shank mounts are indicated to be used with the CD Horizon™ ModuLeX™ Spinal System during surgery. - The ModuLeX™ shank mounts are indicated for skeletally mature patients.

The Stealth™ Spine Clamps are intended to provide rigid attachment between the patient and patient reference frame for the duration of the surgery. The subject devices are designed for use with the Stealth™ System and are intended to be reusable. The ModuLeX™ Shank Mounts are intended to provide rigid attachment between the patient and patient reference frame for the duration of the surgery. The subject devices are designed for use with the Stealth™ System and are intended to be reusable.

The O-arm™ O2 Imaging System is a mobile x-ray system, designed for 2D and 3D imaging for adult and pediatric patients weighing 60 lbs or greater and having an abdominal thickness greater than 16 cm, and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The O-arm™ O2 Imaging System is compatible with certain image guided surgery systems.

The O-arm™ O2 Imaging System is a mobile x-ray system that provides 3D and 2D imaging. The O-arm™ O2 Imaging System consists of two main assemblies that are used together: The Image Acquisition System (IAS) and The Mobile View Station (MVS). The two units are interconnected by a single cable that provides power and signal data. The IAS has an internal battery pack that provides power for motorized transportation and gantry positioning. In addition, the battery pack is used to power the X-ray tank. The MVS has an internal UPS to support its function when mains power is disconnected. The O-arm™ O2 Imaging System operates off standard line voltage within the following voltages: VAC 100, 120 or 240, Frequency 60Hz or 50Hz, Power Requirements 1440 VA.

The StealthStation System, with StealthStation Cranial software, is intended to aid in precisely locating anatomical structures in either open or percutaneous neurosurgical procedures. The system is indicated for any medical condition in which reference to a rigid anatomical structure can be identified relative to images of the anatomy. This can include, but is not limited to, the following cranial procedures (including stereotactic frame-based and stereotactic frame alternatives-based procedures): - Cranial biopsies (including stereotactic) - Deep brain stimulation (DBS) lead placement - Depth electrode placement - Tumor resections - Craniotomies/Craniectomies - Skull Base Procedures - Transsphenoidal Procedures - Thalamotomies/Pallidotomies - Pituitary Tumor Removal - CSF leak repair - Pediatric Ventricular Catheter Placement - General Ventricular Catheter Placement

The StealthStation System, with StealthStation Cranial software helps guide surgeons during cranial surgical procedures such as biopsies, tumor resections, and shunt and lead placements. The StealthStation Cranial Software works in conjunction with an Image Guided System (IGS) which consists of clinical software, surgical instruments, a referencing system and platform/computer hardware. Image guidance, also called navigation, tracks the position of instruments in relation to the surgical anatomy and identifies this position on diagnostic or intraoperative images of the patient. StealthStation Cranial Software functionality is described in terms of its feature sets which are categorized as imaging modalities, registration, planning, interfaces with medical devices, and views. Feature sets include functionality that contributes to clinical decision making and are necessary to achieve system performance.

Synergy Cranial v2.2.9: The StealthStation System, with Synergy Cranial software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical procedures. The system is indicated for any medical condition in which reference to a rigid anatomical structure can be identified relative to images of the anatomy. This can include, but is not limited to, the following cranial procedures: - Cranial Biopsies - Tumor Resections - Craniotomies/Craniectomies - Skull Base Procedures - Transsphenoidal Procedures - Thalamotomies/Pallidotomies - Pituitary Tumor Removal - CSF Leak Repair - Pediatric Catheter Shunt Placement - General Catheter Shunt Placement StealthStation Cranial Software v3.1.4: The StealthStation System, with StealthStation Cranial software, is intended to aid in precisely locating anatomical structures in either open or percutaneous neurosurgical procedures. The system is indicated for any medical condition in which reference to a rigid anatomical structure can be identified relative to images of the anatomy. This can include, but is not limited to, the following cranial procedures (including stereotactic frame-based and stereotactic frame alternatives-based procedures): - Cranial biopsies (including stereotactic) - Deep brain stimulation (DBS) lead placement - Depth electrode placement - Tumor resections - Craniotomies/Craniectomies - Skull Base Procedures - Transsphenoidal Procedures - Thalamotomies/Pallidotomies - Pituitary Tumor Removal - CSF leak repair - Pediatric Ventricular Catheter Placement - General Ventricular Catheter Placement

The StealthStation System, with StealthStation Cranial software helps guide surgeons during cranial surgical procedures such as biopsies, tumor resections, and shunt and lead placements. The StealthStation Cranial software works in conjunction with an Image Guided System (IGS) which consists of clinical software, surgical instruments, a referencing system and platform/computer hardware. Image guidance, also called navigation, tracks the position of instruments in relation to the surgical anatomy and identifies this position on diagnostic or intraoperative images of the patient. StealthStation Cranial software functionality is described in terms of its feature sets which are categorized as imaging modalities, registration, planning, interfaces with medical devices, and views. Feature sets include functionality that contributes to clinical decision making and are necessary to achieve system performance.

The Visualase MRI-Guided Laser Ablation System is a neurosurgical tool and is indicated for use to ablate, necrotize, or coagulate intracranial soft tissue including brain structures (for example, brain tumor, radiation necrosis and epileptic foci as identified by non-invasive and invasive neurodiagnostic testing, including imaging) through interstitial irradiation or thermal therapy in medicine and surgery in the discipline of neurosurgery with 800nm through 1064mm lasers.

The Visualase MRI-Guided Laser Ablation System comprises hardware and software components used in combination with three MR-compatible (conditional), sterile, single-use, saline-cooled laser applicators with proprietary diffusing tips that deliver controlled energy to the tissue of interest. The system consists of: a diode laser (energy source) a coolant pump to circulate saline through the laser application Visualase workstation which interfaces with MRI scanner's host computer Visualase software which provides the system's ability to visualize and monitor relative changes in tissue temperature during ablation procedures, set temperature limits and control the laser output; two monitors to display all system imaging and laser ablation via a graphical user interface and peripherals for interconnections Remote Presence software provides a non-clinical utility application for use by Medtronic only and is not accessible by the user

The StealthStation System, with StealthStation Cranial Software, is intended as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to images of the anatomy. This can include, but is not limited to, the following cranial procedures (including stereotactic frame-based and stereotactic frame alternatives-based procedures): - Tumor resections - General ventricular catheter placement - Pediatric ventricular catheter placement - Depth electrode, lead, and probe placement - Cranial biopsies

The StealthStation™ Cranial Software v1.3.2 works in conjunction with an Image Guided System (IGS) which consists of clinical software, surgical instruments, a referencing system and platform/computer hardware. Image guidance, also called navigation, tracks the position of instruments in relation to the surgical anatomy and identifies this position on diagnostic or intraoperative images of the patient. During surgery, positions of specialized surgical instruments are continuously updated on these images either by optical tracking or electromagnetic tracking. Cranial software functionality is described in terms of its feature sets which are categorized as imaging modalities, registration, planning, interfaces with medical devices, and views. Feature sets include functionality that contributes to clinical decision making and are necessary to achieve system performance.

The StealthStation™ System, with StealthStation™ Spine Software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the spine or pelvis, can be identified relative to images of the anatomy. This can include the following spinal implant procedures, such as: o Pedicle Screw Placement - o Iliosacral Screw Placement o Interbody Device Placement

The StealthStation System, also known as an Image Guided System (IGS), is comprised of a platform, clinical software, surgical instruments and a referencing system. The IGS tracks the position of instruments in relation to the surgical anatomy and identifies this position on diagnostic or intraoperative images of a patient. The StealthStation Spine software helps guide surgeons during spine procedures such as spinal fusion and trauma treatments. StealthStation Spine Software functionality is described in terms of its feature sets which are categorized as imaging modalities, registration, planning, interfaces with medical devices, and views. Feature sets include functionality that contributes to clinical decision making and are necessary to achieve system performance.

The Stealth Autoguide™ System is a positioning and guidance system intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments, based on a pre-operative plan and feedback from an image-guided navigation system with three-dimensional imaging software. The Stealth Autoguide™ System is a remotely-operated positioning and guidance system, indicated for any neurological condition in which the use of stereotactic surgery may be appropriate (for example, stereotactic EEG, laser tissue ablation, etc.). The Midas Rex™ Legend™ depth stop attachment and tools are incision, cutting, removing, and drilling of soft and hard tissue during cranial surgical procedures with the intent to create a hole through the cranium to allow surgeons access to desired surgical locations and/or to facilitate insertion, placement of other surgical devices during such procedures.

Stealth Autoguide™ System: The Stealth Autoguide System is a robotic positioning and guidance system intended to interpret navigation tracker coordinates and surgical plan coordinates from the StealthStation to robotically position and orient instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments to pre-defined plans. Midas Rex™ Legend™ Depth Stop System: The Midas Rex™ Legend™ Depth Stop System consists of a Depth Stop Attachment and specific surgical dissecting tools that will be used in conjunction with the Stealth Autoguide System to create cranial access holes for neurosurgical procedures.

The StealthStation™ System, with StealthStation™ ENT software, is intended as an aid for locating anatomical structures in either open or percutaneous ENT procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to images of the anatomy. This can include, but is not limited to, the following procedures: - · Functional endoscopic sinus surgery (FESS) - · Endoscopic skull base procedures - Lateral skull base procedures

The StealthStation™ ENT software helps guide surgeons during ENT procedures such as functional endoscopic sinus surgery (FESS), endoscopic skull base procedures, and lateral skull base procedures. The StealthStation™ ENT software runs on the StealthStation™ S8 Platform. The StealthStation system is an Image Guided System (IGS), comprised of a platform, clinical software, surgical instruments, and a referencing system (which includes patient and instrument trackers). The IGS tracks the position of instruments in relation to the surgical anatomy, known as localization, and then identifies this position on preoperative or intraoperative images of a patient. The ENT software can display patient images from a variety of perspectives (axial, sagittal, coronal, oblique) and 3-dimensional (3D) renderings of anatomical structures can also be displayed. During navigation, the system identifies the tip location and trajectory of the tracked instrument on images and models the user has selected to display. The surgeon may also use the ENT software to create and store one or more surgical plan trajectories before surgery and simulate progression along these trajectories. During surgery, the software can display how the actual instrument tip position and trajectory relate to the plan, helping to guide the surgeon along the planned trajectory. While the surgeon's judgment remains the ultimate authority, real-time positional information obtained through the StealthStation™ System can serve to validate this judgment as well as guide.

The StealthConnect® System is web-based software to remotely access the StealthStation® Cranial software for viewing, stereotactic surgery planning and collaborating by trained professionals such as physicians, technologists and nurses. The StealthConnect® system has not been validated for primary diagnostic reading of Digital Imaging and Communications in Medicine (DICOM) images. The StealthConnect® Remote Viewing, Planning and Collaboration System is an accessory to the StealthStation® System. It provides a web- based client interface to securely access encrypted storage of DICOM-compliant images via a LAN, and/or the internet using general-purpose computers, and by one or more authorized people. It provides for communication, storage, reformating, and display of DICOM 3.0 compliant image data derived from various sources including CT and MRI. In addition, the system provides access to the surgical planning aspects of StealthStation® software, and can be used to set or review surgical plans for stereotactic surgeries that are compatible with and can be transferred to a StealthStation® System or any DICOM-compliant PACS system. StealthConnect® is not to be used for mammography.

The StealthConnect™ System enables web clients on users' computers to interact with a version of the existing StealthStation Cranial planning software that is running on a cloud-based server. The StealthConnect System enables Secure remote access for one or more authorized users simultaneously, with each accessing different patients (multi-user concurrent planning sessions) via the server-based cranial software using a web browser on user-supplied, general-purpose client computers. A safe environment to access, control, and share images on a secure Health Insurance Portability and Accountability Act (HIPAA) and Health Information Technology for Economic and Clinical Health Act (HITECH) compliance-ready infrastructure. Authorization and access control, which is provided by integration with the user facility's Lightweight Directory Access Protocol (LDAP) or Windows Active Directory (AD) credentialing system (single sign on).