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Mixed Reality Spine Navigation is an accessory to the Spine & Trauma Navigation Medical Device. The software is intended to display 2D navigation screens as well as a floating 3D virtual representation and stereotactic information of tracked instruments on a virtual display using a Mixed Reality headset. The virtual display should not be relied upon solely for absolute positional information and should always be used in conjunction with the displayed stereotaxic information.

The Subject device Mixed Reality Spine Navigation is an accessory to the Spine & Trauma Navigation System. It consists of the software Mixed Reality Spine Navigation 1.0 and the mixed reality headset Magic Leap 2 Medtech (ML2). The software application allows the display in the mixed reality headset of 2D navigation views and a 3D hovering model of the patient anatomy, including stereotactic information of tracked instruments to support the surgeon during pedicle screw placement procedures. The software Mixed Reality Spine Navigation is installed and running on the Magic Leap 2 MedTech glasses and can only be used in combination with a Brainlab Image Guided Surgery (IGS) platform (Curve Navigation 17700, Kick 2 Navigation Station or Buzz Navigation Ceiling-Mounted), where the Spine & Trauma Navigation software is running. All required navigation data, such as the patient registration, is transferred over Wi-Fi from the IGS platform to the Magic Leap 2 MedTech. Based on these data, 2D views and a 3D model are rendered by the computing unit of the Magic Leap 2 MedTech and displayed stereoscopically in the headset. Thus, navigation information displayed on the screen(s) of the IGS platform can be simultaneously displayed on Magic Leap 2 MedTech during the surgery. Magic Leap 2 MedTech is an optical see-through head-mounted display: images are projected on semi-transparent optical layers, giving the surgeons the possibility to have virtual content displayed around the patient while having a view of the real world. If needed, corrective lenses can be attached to the headset.

The ARVIS Surgical Navigation System is indicated for assisting the surgeon in the positioning and alignment of implants relative to reference alignment axes and landmarks in stereotactic orthopedic surgery. The system aids the surgeon in making intraoperative measurements such as changes in leg length in Hip Arthroplasty. The system is compatible with straight acetabular impactors and with specific offset impactors, identified in the instructions for use, for which an adapter has been validated. Example orthopedic surgical procedures include but are not limited to: - Total Knee Arthroplasty - · Unicompartrnental Knee Arthroplasty: Tibial Transverse Resection - · Hip Arthroplasty The ARVIS head mounted display is for displaying augmented reality visualization and information to the user intraoperatively. The augmented/ virtual displayed information should not be relied upon solely for absolute positional/alignment information and should always be used in conjunction with the displayed stereotaxic information.

ARVIS® Surgical Navigation System is a computer-controlled surgical navigation system intended to provide intra-operative measurements to the surgeon to aid in selection and positioning of orthopedic implant components. The subject device is the fundamentally unchanged predicate ARVIS® Surgical Navigation System. It is indicated for use in knee and hip arthroplasties. ARVIS® Surgical Navigation System combines software, electronic hardware and surgical instruments to intraoperatively track tools and locate anatomical structures based on the patient's preoperative imaging. The navigation platform is identical to the predicate and uses the same electronic hardware, mounted on the surgeon's head and waist. The subject device adds the capability to remotely activate graphical user interface (GUI) buttons and check boxes for the surgeon, who optionally can use this to work in conjunction with the current methods of gaze and voice control. The added capability is intended to provide a third alternate option for the surgeon to interact with the software. ARVIS® Surqical Navigation System displays measurements as described in Performance Claims.

Knee+ is a stereotaxic system including an intraoperative software as a medical device and surgical instruments. Knee+ is intended for primary Total Knee Replacement, to assist the surgeon in determining reference alignment axes in relation to anatomical landmarks, in order to position the cutting computed mechanical axis. The Knee+ includes smart glasses as a Head Mounted Device (HMD) for displaying information to the user intraoperatively. The smart glasses should not be relied upon solely and should always be used in conjunction with traditional methods.

Knee+ is a navigation system dedicated to orthopaedic kneePlus software and KneeTools reusable surgical instruments. The main purpose of Knee+ is to assist the surgeon during primary Total Knee Arthroplasty (TKA) interventions. Knee+ provides information to help locate and orientate the main femoral and tibial cutting planes as required during TKA. Knee+ allows the surgeon to adjust the orientation of the cutting plane orientation and the level of resection by collecting anatomical references during the TKA procedure using surgical instruments. The software frame the instruments which include markers. All collected coordinates are treated by software algorithms to provide the surgeon with relevant orientation and location of the tracked cutting guide. Knee+ software is installed on a wearable Head Mounted Device (HMD) which includes a camera, a computer and displays intraoperative information to the user. A near-eye display allows the HMD screen when needed.

The xvision Spine System, with xvision System Software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous spine 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 a patient's fluoroscopic or CT imagery of the anatomy. This can include the following spinal procedures: - Posterior Pedicle Screw Placement in the thoracic and sacro-lumbar region. - Posterior Screw Placement in C3-C7 vertebrae - Iliosacral Screw Placement - Angular procedures requiring access to the disc space - Lateral trajectories required to access the Sacro-Iliac joint The Headset of the xvision Spine System displays 2D stereotaxic screens and a virtual anatomy screen. The stereotaxic screen is indicated for correlating the tracked instrument location to the registered patient imagery. The virtual screen is indicated for displaying the virtual instrument location to the virtual anatomy to assist in percutaneous visualization and trajectory planning. The virtual display should not be relied upon solely for absolute positional information and should always be used in conjunction with the displayed stereotaxic information.

The xvision Spine (XVS) system is an image-guided navigation system that is designed to assist surgeons in placing pedicle screws accurately, during open or percutaneous computer-assisted spinal surgery. The system consists of dedicated software, Headset, single use passive reflective markers and reusable components. It uses wireless optical tracking technology and displays to the surgeon the location of the tracked surgical instruments relative to the acquired patient's scan, onto the surgical field. The 2D scanned data and 3D reconstructed model, along with tracking information, are projected to the surgeons' retina using a transparent near-eye-display Headset, allowing the surgeon to both look at the patient and the navigation data at the same time. This special 510(k) submission outlines minor software modifications to the cleared XVS system, aimed at enhancing the 2D-3D registration process. Changes include minor updates to the C-ARM Ring adaptor, XVS sterile kits with C- and X-markers, and the addition of a patient marker extender for improved reflectors' visibility. A new software version introduces enhancements to the GUI, ease of use, and bug fixes.

ARVIS® Shoulder is indicated for assisting the surgeon in the positioning and alignment of implants relative to reference alignment axes and landmarks in stereotactic orthopedic surgery. The system aids the surgeon in making intraoperative measurements and locating anatomical structures of the shoulder joint based on the patient's preoperative imaging. The system is intended to be used with the head mounted ARVIS® Eyepiece display for augmented reality visualization and information, such as visualization of the preoperative plan and display of instrument and implant alignment information. The augmented/ virtual displayed information should not be relied upon solely for absolute positional/alignment information and should always be used in conjunction with the displayed stereotaxic information. ARVIS® Shoulder is indicated for total shoulder arthroplasty using the Enovis AltiVate, LimaCorporation PRIMA, and LimaCorporation SMR implant systems.

ARVIS® Shoulder is a computer-controlled navigation system for shoulder arthroplasty. It aids the surgeon in making intra-operative measurements and locating anatomical structures of the shoulder joint based on the patient's preoperative imaging to assist with selection and positioning of orthopedic implant components. The system consists of software, electronic hardware and surgical instruments. The ARVIS® Eyepiece is mounted on the surgeon's head and contains tracking cameras that locate the positions of trackers on the patient and instruments. All system measurements, instructions, prompts, and alerts are shown to the surgeon on the Eyepiece display. The Eyepiece communicates with the Belt Pack which is worn by the surgeon around their waist and houses the computer module that runs the ARVIS® Shoulder application software. The device's workflow involves CT based preoperative planning followed by intraoperative navigation and execution. The preoperative planning software enables 3D virtual implant positioning based on the patient's CT reconstructed digital bone model and bony landmarks. The shoulder navigation software then matches the patient's digital bone model and landmarks to the intraoperative landmarks registered by the surgeon, allowing an image-based navigation to follow. The surgeon uses the plan data as guidance to navigate and help position shoulder instruments and implants.

SpineAR SNAP is intended for use for pre-operative surgical planning on-screen and in a virtual environment, and intraoperative surgical planning and visualization on-screen and in an augment using the HoloLens2 and Magic Leap 1 AR headset displays with validated navigation systems as identified in the device labeling. SpineAR SNAP is indicated for spinal stereotaxic surgery, and where reference to a rigid anatomical structure, such as the spine, can be identified relative to images of the anatomy. SpineAR is intended for use in spinal implant procedures, such as Pedicle Screw Placement, in the lumbar and thoracic regions with the Magic Leap 1 and HoloLens2 AR headsets. The virtual display should not be relied upon solely for absolute positional information and should always be used in conjunction with the displayed 2D stereotaxic information.

The SpineAR SNAP does not require any custom hardware and is a software-based device that runs on a high-performance desktop PC assembled using "commercial off-the-shelf" components that meet minimum performance requirements. The SpineAR SNAP software transforms 2D medical images into a dynamic interactive 3D scene with multiple point of views for viewing on a high-definition (HD) touch screen monitor. The surgeon prepares a pre-operative plan for stereotaxic spine surgery by inserting guidance objects such as directional markers and virtual screws into the 3D scene. Surgical planning tools and functions are available on-screen and when using a virtual reality (VR) headset. The use of a VR headset for preoperative surgical planning further increases the surgeon's immersion level in the 3D scene by providing a 3D stereoscopic display of the same 3D scene displayed on the touch screen monitor. By interfacing to a 3rd party navigation system such as a Medtronic StealthStation S8, the SpineAR SNAP extracts the navigation data (i.e. tool position and orientation) and presents the navigation data into the advanced interactive, high quality 3D image, with multiple point of views on a high-definition (HD) touch screen monitor. Once connected, the surgeon can then execute the plan through the intraoperative use of the SpineAR SNAP's enhanced visualization and guidance tools. The SpineAR SNAP supports three (3) guidance options from which the surgeon selects the level of guidance that will be shown in the 3D scene. The guidance options are dotted line (indicates deviation distance), orientation line (indicates both distance and angular deviation), and ILS (indicates both distance and angular deviation using crosshairs). Visual color-coded cues indicate alignment of the tracker tip to the guidance object (e.g. green = aligned). The 3D scene with guidance tools can also be streamed into an AR wireless headset (Magic Leap 1 or HoloLens2) worn by the surgeon during surgery. The 3D scene and guidance shown within the AR headset is projected above the patient and does not obstruct the surgeon's view of the surgical space.

Caduceus S is intended as an aid for precisely locating anatomical structures in percutaneous spine procedures. It is indicated for medical conditions in which the use of stereotactic surgery may be appropriate, when reference to a rigid anatomical structure, such as the spine or pelvis, can be identified relative to CT or 2D/3D C-arm images of the anatomy. This can include the spinal implant procedures, such as Posterior Pedicle Screw Placement in the thoracic and lumbosacral spine. Caduceus S offers pedicle screw implant size planning and navigation on rigid bone structures with intraoperatively registered surgical Instruments. The Headset of the Caduceus S displays 2D stereotaxic screens and a 3D anatomy model (floating). The displayed stereotaxic screens are indicated for correlating the tracked instrument location to the patient registered imagery to assist in percutaneous visualization and trajectory planning.

The Caduceus S system is an image-guided navigation system that is designed to assist surgeons in placing pedicle screws accurately, during percutaneous computer-assisted spinal surgery. The system consists of a dedicated software, Navigation Cart, Navi Tracker, Headset, Minimally Invasive Spine Surgery Instruments, Disposable Passive Spheres, and other disposable surgical consumables. It uses optical tracking technology and displays to the surgeon the location of the tracked surgical instruments relative to the acquired intraoperative patient's scan, onto the surgical field. The 2D scanned data and 3D reconstructed model, along with tracking information, are projected to the surgeons' eyes using a transparent near-eye-display Headset, allowing the surgeon to both look at the patient and the navigation data at the same time.

The xvision Spine System, with xvision System Software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous spine 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 a patient's fluoroscopic or CT imagery of the anatomy. This can include the following spinal procedures: - Posterior Pedicle Screw Placement in the thoracic and sacro-lumbar region. - Posterior Screw Placement in C3-C7 vertebrae - Iliosacral Screw Placement - Angular procedures requiring access to the disc space - Lateral trajectories required to access the Sacro-Iliac joint The Headset of the xvision Spine System displays 2D stereotaxic screens and a virtual anatomy screen. The stereotaxic screen is indicated for correlating the tracked instrument location to the registered patient imagery. The virtual screen is indicated for displaying the virtual instrument location to the virtual anatomy to assist in percutaneous visualization and trajectory planning. The virtual display should not be relied upon solely for absolute positional information and should always be used in conjunction with the displayed stereotaxic information.

The xvision Spine System (XVS) is an image-guided navigation system designed to assist surgeons in placing pedicle screws accurately, during open or percutaneous computer-assisted spinal surgery by displaying stereoscopic augmented reality (AR) navigation onto the patient anatomy. The system consists of dedicated software running on a PC, a headset, single use passive reflective markers, and reusable components. It uses wireless optical tracking technology and displays to the surgeon the location of the tracked surgical instruments relative to the acquired patient's scan, onto the surgical field. The 2D data and 3D reconstructed model, along with tracking information, are projected to the surgeons' retina using a transparent near-eye-display Headset, allowing the surgeon to both look at the patient and the navigation data at the same time. The purpose of this 510(k) submission is to introduce a new registration algorithm that enables registering a 3D CT scan that was acquired prior to surgery (pre-operative CT) using 2D X-ray images, taken intra-operatively with a C-Arm. As part of the development of this registration method, the company developed a new software algorithm that includes a deep learning-based spine segmentation algorithm that segments individual vertebrae including the sacrum and ilium. The segmentation output is used as an input to the new registration algorithm. The indications for use of the subject device compared to its predicate are expanded and include the use of patient's X-ray images for registration and support of angular and lateral procedures requiring access to the disc space and sacro-iliac joint. These modifications do not alter the intended purpose of the system as an aid in localization of anatomical structures during spine surgery or its principles of operation, it just enables additional inputs for registration and supports navigation in additional traiectories.