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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 software is not intended to predict ablation volumes or predict ablation success.

The Navigo Workstation version 2.3, model: FPRMC00039 (hereinafter referred to as "Navigo Workstation Version 2.3") is an adjunctive tool in the management of prostate diagnostic and interventional procedures. The Navigo Workstation provides tracking, recording, and management solutions for prostate insertion tools (such as a needle, guide wire, or catheter).

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, CT) with the ultrasound images and thus superimposes information from one modality onto the other. The device includes means to compensate for the patient's body and prostate motion at any time during the procedure. In addition, the Navigo Workstation Version 2.3 supports treatment procedure by allowing the physician to plan the treatment by selecting a treatment needle with its defined properties (as declared by the manufacturer) and displaying the virtual ablation zone. The system enables the physician to segment anatomic ROIs (anatomic Regions Of Interest, e.g. surrounding organs) and present the distance measurements of the virtual treatment zone from it. The ROIs used for treatment planning can be either ROI segmented on MRI/CT images or positive pathology results updated on historic biopsy procedures performed on the Navigo.

The Navigo Workstation is used as an add-on to the ultrasound diagnostic and interventional procedures of the prostate gland. When operated in conjunction with the standard equipment in trans-rectal/trans-perineal ultrasound prostate procedure, the Navigo software may be used for the following:

• To assist the physician by transferring and displaying ultrasound images on the workstation screen
• To provide regional orientation information during prostate procedures
• To build a display and manipulate a 3D model of the prostate on a screen
• To define the physician's ROIs (Regions Of Interest) and display them on the 3D model
• To archive procedure data and report generating
• To provide data management solutions
• To track, display, and record the needle trajectory location retrieved from the ultrasound
• To display the scanning history, including pathology analyses
• To retrieve and display DICOM-compliant information
• To fuse DICOM-compliant originated regions of interest with the ultrasound 2D and 3D information
• To support the grid trajectory in Grid guided procedures
• To perform automatic or manual compensation for patient movement.
• To support treatment procedure: The module allows pre-procedure planning, real-time display of the treatment needle virtual ablation zone, accurate placement of the needle or insertion tools (such as cryoprobes) on targets, 3D tracking, and distance measurements (proximity) to anatomic ROIs.

The Navigo Workstation Version 2.3 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 2.3 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 2.3 for viewing and creation of a 3D model. As with any other procedure, the Ultrasound 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 2.3 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 enable the 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.

In offline mode, the workstation allows analysis of previous procedures, updates to biopsy locations, report generation, and DICOM-based ROI definition. Offline tools support treatment planning by segmenting anatomical ROIs, displaying virtual treatment regions, and measuring distances from these regions to surrounding structures. Data from prior imaging or biopsy procedures can be utilized for planning.

The device consists of the following components and accessories: The Navigo Workstation cart, electromagnetic transmitter, probe sensor, reference sensor, grid-plate sensor, sensor fixators, reference sensor tape, and cables.

The provided document, an FDA 510(k) Clearance Letter for the Navigo Workstation 2.3, does not contain specific acceptance criteria (e.g., minimum accuracy percentages, sensitivity, specificity thresholds) or a detailed report of device performance against such criteria. The document primarily focuses on demonstrating substantial equivalence to a predicate device through technological similarities and a summary of non-clinical performance testing.

Therefore, I cannot extract a table of acceptance criteria and reported device performance directly from this document. The document lists the types of non-clinical tests performed, but not the quantitative results or the specific acceptance thresholds for those tests.

However, I can provide information based on the listed non-clinical performance testing and general context:

Summary of Device Acceptance and Performance (Based on Provided Document)

The Navigo Workstation 2.3 demonstrated performance through a series of non-clinical (bench) tests and adherence to recognized standards. The document asserts that these tests validate the device's changes and ensure its safety and effectiveness, leading to a conclusion of substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The "acceptance criteria" and "reported device performance" are inferred based on the statement that these tests were conducted to "validate the changes" and ensure "compliance with defined requirements," ultimately supporting the conclusion of substantial equivalence and safety/effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not explicitly stated for any of the bench tests. The description of tests like "Mesh Proximity Test" or "Tests for Margin of ROIs" suggests computational validation rather than a fixed number of physical samples.
• Data Provenance: The tests are described as "Bench Testing" performed by UC-Care. This indicates a controlled, laboratory-type setting. There is no mention of country of origin for test data, but the company is based in Israel. The tests are non-clinical, so the concept of retrospective or prospective data as typically applied to patient studies does not directly apply.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Number of Experts: Not mentioned.
• Qualifications of Experts: Not mentioned. For bench tests, ground truth would likely be established by engineering specifications, computational models, or known physical properties rather than human experts in the clinical sense.

4. Adjudication Method for the Test Set

• Adjudication Method: Not mentioned. It's improbable that an adjudication method like 2+1 or 3+1 would be applicable for these types of non-clinical bench tests.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study Done? No. The document explicitly states: "No clinical Study was performed for the purpose of this submission." and "Clinical performance data was not required to demonstrate safe and effective use of Navigo workstation 2.3."

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Standalone Study Done? Not directly stated as a "standalone study" with specific performance metrics (e.g., AUC, sensitivity, specificity). However, the "Non-Clinical Performance Testing" on specific software features (e.g., Mesh Proximity, Virtual Ablation Zone Display, Margin addition) inherently evaluates the algorithm's performance in a standalone manner, as it's testing the computational output of these features against defined requirements or specifications. The document doesn't provide the quantitative results of these standalone algorithmic evaluations, only that they were performed and validated the changes.

7. Type of Ground Truth Used

• Type of Ground Truth: For the non-clinical bench tests, the ground truth appears to be based on:
  • Defined specifications/requirements: For software functionalities (e.g., accurate calculation of shortest distance, accurate margin addition, accurate display of ablation zone aligned with manufacturer specs).
  • Recognized consensus standards: For general software, electrical safety, EMC, and risk/usability (IEC 62304, IEC 60601 series, ISO 14971).
  • Internal existing test methods: Previously utilized for legally marketed devices by UC-Care.

8. Sample Size for the Training Set

• Training Set Sample Size: Not applicable/not mentioned. This device is a medical image management and processing system with new software features and hardware updates, not an AI/ML device that requires a distinct "training set" in the context of machine learning model development. The document does not describe the use of a machine learning component that would necessitate a training set.

9. How Ground Truth for the Training Set Was Established

• Ground Truth for Training Set: Not applicable, as there is no mention of a training set for machine learning.

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