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Pecoraro et al. Mini-invasive Surg 2024;8:25  https://dx.doi.org/10.20517/2574-1225.2023.134  Page 3 of 12

               Table 1. Standardized workflow for 3DVM creation
                Stage        Key actions                              Standards and guidelines
                1. Image acquisition - Use standardized imaging protocols for CT, MRI, and   - Slice thickness: 1 mm for CT
                             Ultrasound                               - MRI contrast sequences: T1, T2, DCE
                             - Set specific scan parameters
                2. Data      - Apply noise reduction and contrast enhancement   - Use ISO-certified image processing software
                preprocessing  - Align images using standardized software  - Require predefined contrast thresholds
                3. Segmentation  - Use AI/ML algorithms for automatic segmentation   - Segmentation tools should have a ≤ 5% error margin
                             - Refine manually when necessary         - Follow ISO/IEC 62304 standards
                4. Model     - Construct 3D models based on processed images   - Accuracy margin: ≤ 0.5 mm for critical structures
                generation   - Verify accuracy of organ and tumor shapes  - Follow ISO/IEC 9001 for quality
                5. Validation  - Perform validation checks against reference standards (e.g.,   - Validation protocol requiring ≤ 1 mm deviation from
                             cadaver models)                          actual anatomy
                                                                      - Document deviations
               3DVM: Three-dimensional virtual model; CT: computed tomography; MRI: magnetic resonance imaging; DCE: dynamic contrast enhanced; AI:
               artificial intelligence; ML: machine learning.


               Table 2. Accuracy benchmarking for 3DVMs

                Structure   Target accuracy   Validation methods           Benchmark example
                            margin
                Kidney tumor  ≤ 0.5 mm       Validate against intraoperative ultrasound or   Comparison with surgical specimen post-
                                             MRI                           nephrectomy
                Renal       ≤ 1 mm           Validate with angiographic imaging or Doppler  Correlation with intraoperative vascular
                arteries/veins               scan                          examination
                Surrounding   ≤ 2 mm         Use cross-sectional imaging for accuracy   Compare with 2D CT or MRI results post-surgery
                organs                       check
               3DVMs: Three-dimensional virtual models; MRI: magnetic resonance imaging; CT: computed tomography.


               2. Preprocessing: The 2D DICOM images are reviewed using specialized software, such as those that allow
               contrast and luminance adjustments. Images are chosen based on the phase that provides the most
               diagnostic value (e.g., arterial or late-phase CT scans).


               3. Volume Rendering: The software automatically generates an initial 3D model from the voxels (the 3D
               counterpart of 2D pixels). This initial model gives an overview of the anatomical structure and highlights
               areas that may require further attention.


               4. Segmentation: The segmentation process is performed using specialized software. Segmentation involves
               separating pixels that belong to regions or objects of interest (ROIs/OOIs), based on a chosen similarity
               criterion (e.g., color). One of the simplest methods for identifying different ROIs and OOIs is
               “thresholding”. By setting a specific parameter range (such as a gray scale, that represents the density of
               different tissues and structures in the CT image), the software can detect areas with the desired
               characteristics. However, as the ROIs could have similar gray values, the results could be inaccurate. This
               step is crucial in the creation of 3D models, as the software may not always accurately recognize and
               represent all elements, requiring manual adjustments. For example, a threshold of 1,330 GVs is used to
               segment the collecting system while avoiding the surrounding renal pyramids. Similarly, when it is
               necessary to include more surrounding structures, a threshold of 1,330 GVs could be used . Since different
                                                                                           [6]
               phases are used to capture the collecting system and other anatomical parts, it is essential to align the
               segmented regions. Interactive translation and rotation tools are used to adjust the orientation and position
               of these different segments, ensuring that they accurately represent the kidney’s anatomy in the 3D model,
               and also in case of pyeloureteral malformation. At this stage, the engineer’s expertise is essential, allowing
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