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The UC-Care Navigo Workstation is an adjunctive tool for ultrasound guided procedures and is intended to be used by physicians in the clinic or hospital for 2-D and 3-D visualization of ultrasound images of the prostate gland. The Navigo Workstation offers the ability to fuse DICOM originated information (e.g. MRI, CT) with the ultrasound images and thus superimposes information from one modality onto the other.

It also provides the ability to display a simulated image of a tracked insertion tool such as a needle, guide wire, catheter, grid plate or probe on a computer monitor screen that shows images of the target organ and the current and the projected future path of the interventional instrument taking into account patient movement. Additional software features include patient data management, multiplanar reconstruction, segmentation, image measurement and 3-D image registration, as well as storage and future retrieval of this information.

Navigo is intended for treatment planning and guidance for clinical, interventional and/or diagnostic procedures. The device is intended to be used in interventional and diagnostic procedures in a clinical setting. Example procedures include, but are not limited to image fusion for diagnostic clinical examinations and procedures, soft tissue biopsies, soft tissue ablations and placement of fiducial markers.

The Navigo Workstation Version 2.0 is an adjunctive tool in the management of prostate diagnostic and interventional procedures. The Navigo Workstation Version 2.0 allows prostate needle tracking, recording, and management solution. The Navigo Workstation Version 2.0 is designed to assist the physician in performing prostate diagnostic and interventional procedures by providing regional orientation information, displaying a 3D model with real-time tracking and recording of the needle location. The Navigo Workstation Version 2.0 offers the ability to fuse DICOM originated information (e.g. MRI, CT) with the ultrasound images and thus superimposes information from one modality onto the other. The device includes means to compensate for patient body and prostate motion at any time during the procedure.

The Navigo Workstation Version 2.0 is designed to work with standard trans-rectal / transperineal ultrasound systems and biopsy setup without changing or interfering with the physician's existing workflow. The Navigo Workstation Version 2.0 connects to the video output of the ultrasound system and by tracking the ultrasound probe's position, the recorded 2D ultrasound images are transferred to the Navigo Workstation Version 2.0 for viewing and creation of a 3D model. As with any other procedure, the US probe is used together with a standard disposable cover sheath supplied by the user.

Two dimensional (2D) images and the 3D model of the prostate are displayed on the Navigo Workstation Version 2.0's screen. The Navigo Workstation Version 2.0 is equipped with tools to manipulate (rotate, pan, zoom) the model, and to archive and retrieve the information for further use.

The tracking and recording enables display of an accurate 3D model of the prostate and to record needle locations on the model. Pathology diagnosis results may be updated on the 3D model and a color display representation provides a visual display of the pathology results.

The Navigo Workstation Version 2.0 supports the display of ROIs on the 3D model and displays visual indication when the needle trajectory intersects with an ROI (Region Of Interest) is defined by the physician by segmenting a portion of the prostate on a 2D image and displaying its location on the 3D model, thereby defining a portion of the prostate as a target to direct a needle within. The 2D images for segmentation of the ROI can be either a frozen Ultrasound image or a DICOM compliant image from another imaging study completed prior to the Ultrasound procedure (e.g. MR,CT).The ROls are clearly numbered and labeled by a letter symbolizing its origin (Ultrasound or DICOM). On each image, more than one ROI may be defined (segmented).

The live 2D ultrasound image is superimposed in real-time with the 2D ROI boundaries thus allowing the physician to see the real-time advancement of the needle on the live ultrasound image with reference to ROI boundaries. The 3D model is displayed on a separate window alongside the ultrasound's live continuous images display, allowing prostate 3D orientation.

Regardless of the type of ultrasound probe used for the procedure (side-fire or end-fire) a cannula for a needle is built within the outer shell of the probe and therefore a needle can be inserted through the designated cannula. The designated cannula defines the needle path along its trajectory. The needle trajectory is displayed on the 3D model representing the potential needle route to allow the physician to direct the needle in real time into the target. When the projected path intersects with an ROI, the ROI will change indicating the needle can be directed inside the ROI if the physician ensures that the needle is inserted deep enough. In trans-perineal procedures the grid-plate sensor is placed on the grid base via a fixator; the sensor tracks the grid location during the procedure and enables the Navigo Workstation Version 2.0 to present in real time the optional trajectories locations. During the procedure, the physician may change some of the parameters on the US system or perform different actions that require the Navigo Workstation Version 2.0 to adjust. A physician may wish to freeze an image and perform measurements, label the image and save it to the report, switch between transversal and longitudinal view, or change the view of the ultrasound image. The Navigo Workstation Version 2.0 is equipped with image state algorithms to automatically detect the change in parameters and adjust itself to the new parameters. For example, if the physician freezes the US image, the Navigo Workstation Version 2.0 will automatically present additional menu option for a frozen image like measurements tools and labeling. The image state algorithm was developed to support generic ultrasound parameters and is specifically tested for each new ultrasound system model the Navigo Workstation Version 2.0 is required to support. In case of auto-detection failure, the user is informed and asked to confirm or manually change the detected parameters In order to continue.

In off-line mode, the Navigo Workstation Version 2.0 software further enables the physician to analyze previous procedures using the prostate model, update the 3D model if necessary. update the recorded biopsies' locations, generate reports, and provides a DICOM (MRI/CT) interface for ROI definition, 3D model display, and data communication.

Here is an analysis of the acceptance criteria and supporting studies for the Navigo Workstation Version 2.0, based on the provided text:

1. Table of Acceptance Criteria & Reported Device Performance:

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