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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) with the ultrasound images and thus superimpose information from one modality onto the other. Additional software features include patient data management, multi-planar reconstruction, segmentation, image measurement and 3-D image registration.

The device is specifically indicated to provide information within the prostate to assist needle targeted procedures (e.g. biopsy) regions of interest display, procedures planning and, reconstruction of a 3D rendered surface model of the prostate display needle locations that have been selected by the physician, as well as storage and future retrieval of this information.

The NaviGo™ Workstation is an adjunctive tool in the management of prostate diagnostic and interventional procedures. The NaviGo™ Workstation allows prostate needle tracking, recording, and management solution. The NaviGo™ Workstation 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 offers the ability to fuse DICOM originated information (e.g. MRI) with the ultrasound images and thus superimpose information from one modality onto the . The device includes means to compensate for patient body and prostate motion at any time during the procedure.

The NaviGo™ Workstation is designed to work with standard trans-rectal ultrasound systems and biopsy setup without changing or interfering with the physician's existing workflow. The NaviGo™ Workstation 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 for viewing and creation of a 3D model. As with any other procedure, the TRUS probe is used together with 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's screen. The NaviGo™ Workstation 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 biopsy results.

The NaviGo™ Workstation 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 model for segmentation of the ROI can be either an Ultrasound image frozen during the procedure or a DICOM complaint image from another imaging study completed prior to the Ultrasound procedure (e.g. MR) when selecting the fusion procedure to display the planned targets. The ROIs are clearly numbered and labeled by a letter symbolizing it 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 RQL the color of the ROI will change indicating the needle can be directed inside the ROI if the physician ensures that the needle is inserted deep enough.

During the procedure, the physician may change some of the parameters on the US system or perform different actions that require the NaviGo™ Workstation 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 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 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 the NaviGo™ is required to support.

In off-line mode, the NaviGo™ 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 report, and provides a DICOM (e.g. MRI) interface for ROI definition, 3D model display, and data communication.

The information provided focuses on the non-clinical performance data for the NaviGo™ Workstation, specifically for its fusion accuracy and illustration model performance.

1. Table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance:

• Fusion accuracy performance test:
  • Sample size: 4 phantoms, each with 3 isoechoic lesions (total 12 lesions). 34 ultrasound-guided biopsies were targeted.
  • Data provenance: Bench testing using CIRS Model 778-05 phantoms. This is a controlled experimental setting, not from patients or a specific country of origin. It is a prospective study as the testing was conducted to evaluate the device.
• Illustration model performance test:
  • Sample size: 10 prostates (presumably phantom or cadaver prostates, given it's non-clinical bench testing).
  • Data provenance: Bench testing. This is a prospective study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not provided in the document. The tests described are non-clinical (bench) tests involving phantoms. The ground truth for the fusion accuracy test was established by post-procedure CT scans, which accurately measure the needle location relative to the ROI. For the illustration model, the "full contours 3D model" served as the reference for comparison. Expert involvement in establishing the ground truth for these specific bench tests is not mentioned or implied in this summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• This information is not provided as the tests described are non-clinical bench tests comparing device output to a physical ground truth (CT scan for fusion, and a reference 3D model for illustration). Adjudication, typically involving human readers, is not relevant to these specific tests.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• An MRMC comparative effectiveness study was not done as part of the non-clinical performance data described. The document focuses on standalone device accuracy and model performance, not human-in-the-loop performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Yes, the tests described are standalone performance evaluations of the NaviGo™ Workstation's algorithms and functionalities without human interpretation or assistance in the loop for the performance metrics.
  • The "fusion accuracy performance test" assesses how accurately the system targets ROIs based on its internal calculations and guidance.
  • The "illustration model performance test" evaluates the accuracy of the system's generated 3D models.

7. The type of ground truth used:

• Fusion accuracy performance test: Post-procedure CT scan (objective imaging gold standard for physical needle placement relative to a lesion).
• Illustration model performance test: The "full contours 3D model" created by the NaviGo Workstation served as the ground truth for comparison with the "Fast 3D model." This implies that a more detailed or labor-intensive method of 3D model creation by the device itself (or potentially overseen by an operator) was considered the reference.

8. The sample size for the training set:

• This information is not provided in the document. The summary focuses on the performance evaluation of the device, not its development or training data.

9. How the ground truth for the training set was established:

• This information is not provided in the document, as the training set details are not mentioned.

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