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510(k) Data Aggregation

    K Number
    K243623
    Device Name
    SpineAR SNAP (SyncAR Spine)
    Manufacturer
    Surgical Theater, Inc.
    Date Cleared
    2024-12-24

    (29 days)

    Product Code
    SBF, LLZ
    Regulation Number
    882.4560
    Why did this record match?
    Applicant Name (Manufacturer) :

    Surgical Theater, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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.
    Device Description
    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.
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    K Number
    K213034
    Device Name
    SpineAR SNAP
    Manufacturer
    Surgical Theater, Inc.
    Date Cleared
    2022-09-29

    (373 days)

    Product Code
    OLO, LLZ
    Regulation Number
    882.4560
    Why did this record match?
    Applicant Name (Manufacturer) :

    Surgical Theater, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SpineAR SNAP is intended for use or 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 AR headset, and in the lumbar region with the HoloLens2 AR headset. 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.
    Device Description
    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 surgeons view of the surgical space.
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    K Number
    K201465
    Device Name
    SuRgical Planner (SRP) BrainStorm
    Manufacturer
    Surgical Theater, Inc.
    Date Cleared
    2020-07-17

    (45 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Surgical Theater, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SuRgical Planner (SRP) BrainStorm is intended for use as a software interface and image segmentation system for the transfer of image information from a CT, MR, or X-ray 3D Angiography (XA) medical scanner to an output file. It can also be used for pre-operative planning and surgical training in a virtual environment.
    Device Description
    The SuRgical Planner (SRP) BrainStorm is intended for use as a software interface and image segmentation system for the transfer of image information from a CT, MR, or X-ray 3D Angiography (XA) medical scanner to an output file. It can also be used for pre-operative planning and surgical training in a virtual environment. The SuRgical Planner (SRP) BrainStorm is not intended to be used for diagnosis. The SRP BrainStorm software has the ability of creating 3D models of the patient data from 2D scan slices. Additionally, it provides the user with the ability to input, display, color, and manipulate the 2D scan slices via a 3D representation. The software transforms 2D medical images into a dynamic interactive 3D scene with multiple point of views on a high-definition (HD) touch screen monitor. The use of a virtual reality (VR) or augmented reality (AR) headset provides the surgeon a 3D stereoscopic display of the same scene inside the VR / AR headset. While wearing the VR / AR headset, the surgeon can perform a virtual / simulated "fly-through" inside the 3D scene using controllers to perform such actions as rotate, zoom in and zoom out. The use of the SuRgical Planner (SRP) BrainStorm with VR / AR headset and controllers is not intended for use during surgery. The SRP BrainStorm is intended for use for pre-operative planning. The SRP BrainStorm software includes additional features to facilitate the review of relevant data by a multidisciplinary team that includes neurosurgeons and neurologists for pre-operative surgical planning. The SRP BrainStorm product does not include any custom hardware and is a software-based device that runs on a high-performance desktop PC assembled using "commercial off-the-shelt" components that meet minimum performance requirements. The design is based on an advanced, touch screen friendly, Graphical User Interface (GUI) that runs an underlying simulation engine to process medical images in DICOM format, and an image generator software engine.
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