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MeVis Liver Suite is an image analysis software and intended to be used for visualization of hepatic imaging studies derived from CT and MR scanning devices (image source: single- and multiframe DICOM).

MeVis Liver Suite supports physicians in their workflow for evaluating the liver, related vascular anatomy, and the volume of liver and liver vascular territories for treatment planning, preoperative evaluation of surgery strategies, and post-procedure or therapy follow-up assessment of the hepatic system and related vascular structures.

MeVis Liver Suite supports image analysis for multiphase contrast enhanced CT, dynamic contrast enhanced MRI, and MRCP. MeVis Liver Suite only allows import of homogenous image series (i.e., image and pixel size must be constant within each series) and with orthogonal image matrix (without a gantry tilt). Images with a resolution of > 5mm slice spacing are not suitable for image analysis with MeVis Liver Suite.

MeVis Liver Suite can be used for manual segmentation, user-defined manual labeling, and 3D visualization of:

• abdominal organs (i.e., liver, stomach, duodenum, spleen, kidney, gallbladder, and pancreas)
• liver related vascular structures (i.e., bile ducts, hepatic vein, portal vein, and inferior vena cava)
• lesions inside and adjacent to the liver

The tools for manual segmentation and 3D visualization are applicable for CT and MR imaging studies. In addition to the manual segmentation tools, MeVis Liver Suite provides AI based semi-automatic pre-segmentation tools for liver, hepatic artery, hepatic vein restricted to CT scans of potential living liver donors with healthy livers and intended for:

• Liver: contrast enhanced late-venous and venous phase
• Hepatic vein: contrast enhanced late-venous and venous phase
• Portal vein: contrast enhanced late-venous and venous phase
• Hepatic artery: contrast enhanced arterial phase

Using MeVis Liver Suite, users can evaluate the segmented objects by exploring, and manually correcting:

• the volume of the segmented abdominal organs (see above)
• the volume of the segmented lesions inside and adjacent to the liver
• the volume of the manually defined parts of the liver
  • by defining separation planes ("separation proposals")
• from vascular territories that are derived from the user-defined labeling of the liver related vascular structures
• 3D visualizations of user-defined (vascular) tumor margins (coloring of area based on user-defined margin sizes/ distances - between the edges of user-defined lesions in relation to the edges of user-defined vascular structures of the liver)
• based on user provided values, calculation of liver volume to body weight ratios (i.e., estimated weight for remnant or graft, body surface area, graft to recipient body weight ratio, graft to SLV ratio, remnant to body weight ratio).

Using a manual spatial registration of the images, the segmented objects (created on different CT phases and MRI sequences) can be visualized together.

The information created with MeVis Liver Suite is intended to be used only in addition to the original images, clinical data, and the real anatomical and clinical situation. Physicians make all final patient management, and treatment decisions.

MeVis Liver Suite is not intended for the anatomical systems integumentary, skeletal, muscular, lymphatic, respiratory, nervous, reproductive, and cardiovascular (excluding hepatic).

MeVis Liver Suite does not support the following application areas: real time viewing, diagnostic review, mage manipulation, optimization, virtual colonoscopy, and automatic lesion detection.

MeVis Liver Suite does not utilize high-resolution displays or display drivers and should not be used as a replacement for a PACS workstation.

MeVis Liver Suite is an image analysis software and intended to be used for visualization of hepatic imaging studies derived from CT and MR scanning devices (image source: single- and multiframe DICOM).

MeVis Liver Suite supports physicians in their workflow for evaluating the liver, related vascular anatomy, and the volume of liver vascular territories for treatment planning, preoperative evaluation of surgery strategies, and post-procedure or therapy follow-up assessment of the hepatic system and related vascular structures.

The information created with MeVis Liver Suite is intended to be used only in addition to the original images, clinical data, and the real anatomical and clinical situation. Physicians make all final patient management, assessment, and treatment decisions.

Software and Operating System
MeVis Liver Suite is a standalone software application that can be installed on any PC that runs on Windows 10 which meet the hardware requirements.

Supported Modalities
DICOM compatible CT and MR image data with or without contrast.

The tools for manual segmentation and 3D visualization (see below) are applicable for CT and MR image data with the exception of the Al based semi-automatic pre-segmentation tools. The semi-automatic pre-segmentation tools are restricted to CT scans of potential living liver donors with healthy livers.

Image import and selection
MeVis Liver Suite supports image analysis for multiphase contrast enhanced CT, dynamic contrast enhanced MRI, and MRCP. MeVis Liver Suite only allows import of homoqenous image series (i.e., image and pixel size must be constant within each series) and with orthogonal image matrix (without a gantry tilt). Images with a resolution of > 5mm slice spacing are not suitable for image analysis with MeVis Liver Suite.

MeVis Liver Suite can be used to manually select DICOM images (CT and MR) for import. The user can visually inspect the images, if the anatomical structures are visible and if the image resolution and image quality is acceptable for the manual segmentation and the user's needs.

Seqmentation and 3D visualization
MeVis Liver Suite provides multiple contouring tools for manual segmentation.

The user has full control over the workflow and decides which structures to segment. 3D visualizations are created on demand. The following segmentation workflows are available:

. Abdominal organs
MeVis Liver Suite is intended to be used to manually segment and visualize liver, stomach, duodenum, spleen, kidney, gallbladder, or pancreas using contouring tools. Users can inspect and manually correct, add, and delete their segmentation until they are satisfied with the result. The following tools are available:

• o Freehand contouring
• o Region Growing

. Liver related vascular structures
MeVis Liver Suite is intended to be used to manually segment and visualize bile ducts. hepatic artery, hepatic vein, portal vein, and inferior vena cava, including the option to manually classify different vessels of the vascular branches by assigning them userdefined labels. Users can inspect and manually correct, add, and delete their segmentation until they are satisfied with the result. The following tools are available:

• o Freehand drawing and freehand contouring
• Region Growing o
• o Edit and label 3D tree

. Lesions inside and adjacent to the liver
MeVis Liver Suite is intended to be used to manually seqment, visualize, and label user identified lesions inside and adjacent to the liver using:

• o Freehand contouring
  MeVis Liver Suite does not identify or highlight lesions or other abnormalities.

Additionally, the user can use Al based semi-automatic pre-segmentation of liver and liver related vascular structures to create a segmentation proposal. The semi-automatic preseqmentation uses locked/non adaptive Al networks.

● Semi-automatic pre-segmentation of the liver

• Supported modalities
  • CT, contrast enhanced late-venous and venous phase
• o Limitations

■ Only intended for living donor liver transplantation cases (healthy livers)

• Semi-automatic pre-segmentation for liver related vascular structures ●

• Supported modalities o

  • Hepatic vein: CT, contrast enhanced late-venous and venous phase .
  • Portal vein: CT, contrast enhanced late-venous and venous phase
  • . Hepatic artery: CT, contrast enhanced arterial phase

• o Limitations

  • Only intended for living donor liver transplantation cases (healthy livers)

Evaluation of segmented objects
Users can evaluate the segmented objects by exploring, and manually correcting:

• Volume
  MeVis Liver Suite calculates the volume (via voxel-counting of segmentation mask) and displays the volume information to the user for the following manually segmented objects:

• o Abdominal organs (i.e., liver, stomach, duodenum, spleen, kidney, gallbladder, pancreas)

• o Lesions inside and adjacent to the liver

• Manually defined parts of the liver o

  • . "Separation proposals"

The user can manually define separation planes that part the liver into virtual parts. The user manually labels the parts as either "resection"," graft" (for coloring the 3D visualization of the user-defined part with a red color), or "remnant" (green color)

• = "Vascular territories" Using the user-defined labeling (name and color) of vessel subtrees, the software calculates seqmentation masks for the corresponding vascular territories within the liver
• 3D visualizations of user-defined (vascular) tumor margins (coloring of area based . on user-defined margin sizes/distances - between the edges of user-defined lesions in relation to the edges of user-defined vascular structures of the liver)
  • o The distance of vascular structures to user selected lesions can be visualized with colored 3D visualizations:
    • · with color coded vascular structures ("vascular tumor margins")
    • . with color coded voxels around a lesion inside the liver ("tumor margins")
• Based on user provided values, calculation of liver volume to body weight ratios ● MeVis Liver Suite provides the following calculations:
  • Estimated Weight for Remnant and Graft O
  • Body Surface Area o
  • Graft to Recipient Body Weight Ratio o
  • Graft to Standard Liver Volume (SLV) Ratio o
  • Remnant Volume to Body Weight Ratio o

Manual spatial registration
MeVis Liver Suite supports performing a manual spatial registration of the images from different modalities and studies (CT and MR). The user can manually align the imported images visually in pairs on top of each other using manual rigid registration.

Reporting
Using MeVis Liver Suite, the user can report results of the image analysis in different formats (DICOM for archiving, with DICOM definitions for 2D segmentation and 3D volumes; HTML report).

Here's a breakdown of the acceptance criteria and study details for the MeVis Liver Suite device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set (AI Pre-segmentation)

• Liver AI Pre-segmentation: Not explicitly stated, but the study used a "retrospective multi-center performance study" and "subgroup analysis indicates that the AI algorithm generalize well across all subgroups." More specific numbers like total cases or institutions are not provided.
• Liver related vascular structures AI Pre-segmentation (HV, PV, HA): "a representative clinical multi-center dataset" was used. The exact number of cases or patients is not specified.
• Data Provenance: Retrospective, multi-center. No specific countries are mentioned.

3. Number and Qualifications of Experts for Ground Truth (Test Set)

• Liver AI Pre-segmentation: Not explicitly stated how many experts established the ground truth for this metric.
• Liver related vascular structures AI Pre-segmentation (HV, PV, HA): "3 board certified surgeons/radiologists" were used for qualitative assessment. Their specific experience (e.g., "10 years of experience") is not detailed beyond "board certified".

4. Adjudication Method for the Test Set

• Liver AI Pre-segmentation: Not explicitly stated. The DICE score and Hausdorff Distance are quantitative metrics, implying a direct comparison to a ground truth, rather than an adjudication process between expert segmentations.
• Liver related vascular structures AI Pre-segmentation (HV, PV, HA): "3 board certified surgeons/radiologists" provided scores using a 5-point Likert scale. This implies a consensus or individual scoring approach, but a specific adjudication method (e.g., 2+1, 3+1) is not detailed.

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

• No, an MRMC comparative effectiveness study demonstrating how much human readers improve with AI vs. without AI assistance was not reported. The performance data focuses on the standalone performance of the AI pre-segmentation algorithm.

6. Standalone (Algorithm Only) Performance Study

• Yes, a standalone performance study was done for the AI-based semi-automatic pre-segmentation tools.
  • For the liver, the standalone performance was assessed using DICE score and 95% Hausdorff Distance.
  • For the liver-related vascular structures, bench tests comparing AI output with ground truth, and qualitative expert scoring on a clinical dataset, were performed.

7. Type of Ground Truth Used (Test Set)

• Liver AI Pre-segmentation: The metrics (DICE score, Hausdorff Distance) imply a quantitative comparison to an established "ground truth" segmentation. How this ground truth was derived (e.g., expert consensus, manual gold standard) is not explicitly detailed but typically for segmentation tasks, it involves expert manual annotation.
• Liver related vascular structures AI Pre-segmentation (HV, PV, HA): Bench tests compared AI output with "ground truth annotated by qualified experts." The qualitative assessment involved "expert scores." This suggests expert-annotated ground truth.
• Volume Calculation: "Digital simulated phantom data with a reference value" was used for accuracy, and "clinical test data" for precision. For simulations, the reference value would be the known volume of the phantom. For clinical data, the ground truth for volume calculation precision is implicitly based on repeatability tests against a reference process.

8. Sample Size for the Training Set

• The document does not provide any details regarding the sample size used for training the AI models.

9. How the Ground Truth for the Training Set was Established

• The document does not provide any details on how the ground truth for the training set was established.

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