MeVis Liver Suite by MeVis Medical Solutions AG

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.

Device Description

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.

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).

AI/ML Overview

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

Feature/Metric	Acceptance Criteria (Implicit)	Reported Device Performance (MeVis Liver Suite)
Liver AI Pre-segmentation	Median DICE score similar to reference device (0.85)	Median: 0.98
	Median 95% Hausdorff Distance (HD) similar to reference device (2.0 mm)	Median: 1.5 mm
Liver related vascular structures AI Pre-segmentation (HV, PV, HA)	Algorithms performed as expected (bench tests vs. ground truth).	Qualitative expert scoring: >80% of expert scores rated results as sufficiently accurate.
Volume Calculation Accuracy	Pass criteria for accuracy of volume calculation (against reference values in simulated phantom data)	Fulfilled
Volume Calculation Precision (Repeatability)	Pass criteria for precision of volume calculation (based on representative clinical test data)	Fulfilled

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.

Summary

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Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

MeVis Medical Solutions AG Rolf Rzodeczko Manager Regulatory Affairs Caroline-Herschel-Strasse 1 BREMEN, BREMEN 28359 GERMANY

Re: K232045

Trade/Device Name: MeVis Liver Suite Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: September 27, 2023 Received: September 27, 2023

Dear Rolf Rzodeczko:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Digitally signed by for Gabriela M. Rodal -S

Lu Jiang, Ph.D. Assistant Director DHT8B: Division of Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K232045

Device Name MeVis Liver Suite

Indications for Use (Describe)

Me Vis Liver Suite supports image analysis for multiphase contrast enhanced CT, dynamic contrast enhanced MRJ, 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

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.

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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.

Intended Patient Population:

In addition, the semi-automatic pre-segmentation tools are restricted to CT scans of potential living liver donors with healthy livers.

Intended Part of the Body:

Images supported for the intended medical include the abdominal body part with the liver and related vascular structures (bile ducts, hepatic artery, hepatic vein, inferior vena cava).

Intended User Profile: The intended users are radiologists and surgeons.

Intended Use Environment:

The use environment is expected to be in an office environment under typical office conditions in hospitals or medical practices.

Operation Principle:

The software acts as modality for display of CT or MR imaging data, and for visualization of the image analysis results on a computer system. MeVis Liver Suite does not come into direct contact with patients or other medical devices.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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K232045 510(k) Summary

1 Submitter

Submitted Name:	MeVis Medical Solutions AGCaroline-Herschel-Straße 128359 BremenGermany
Establishment Name:	MeVis Medical Solutions AG
EstablishmentRegistration Number:	3010601176
Date Prepared:	07/10/2023
Contact Person:	Rolf RzodeczkoManager Regulatory Affairs
Telephone:	+49 (0)421 22495-120
Fax:	+49 (0)421 22495-999
2 Device
Device Trade Name:	MeVis Liver Suite
Device Common Name:	MeVis Liver Suite
Regulation:	21 CFR 892.1750
Classification Name:	Computed tomography x-ray system
Product Code:	JAK
Class:	Class II
Panel:	Radiology

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3 Primary Predicate Device

510(k) Number	Primary Predicate Device	Product Code
K133643	syngo.CT Liver Analysis	JAK

4 Secondary Predicate Device(s)

510(k) Number	Secondary Predicate Device	Product Code
K173420	Radiomics App v1.0	LLZ

5 Reference Device1

510(k) Number	Reference Device	Product Code
K193562	Al-Rad Companion Organs RT	QKB

6 Device Description

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

1 Reference device for liver Al pre-seqmentation performance acceptance criteria

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semi-automatic pre-segmentation tools are restricted to CT scans of potential living liver donors with healthy livers.

lmage 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.

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
Me/is Liver Suite does not identify or highlight lesions or other abnormalities.

● 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 ●

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Image /page/7/Picture/0 description: The image shows the word "MeVis" in a teal color. The font is sans-serif and appears to be bolded. The letters are evenly spaced and the word is horizontally oriented.

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"

= "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).

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7 Indications for Use

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 Al based semi-automatic pre-segmentation tools for liver, hepatic artery, hepatic vein, and portal 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
- o by defining separation planes ("separation proposals")
- from vascular territories that are derived from the user-defined labeling of the liver o 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).

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

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, image 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.

Intended Patient Population:

The intended patients for MeVis Liver Suite are oncologic patients or hepatic donor/transplant patients. CT or MR imaging with contrast agents need to be possible for analysis of vascular structures inside the liver. The age group for the intended patient population is 18 or older. In addition, the semi-automatic pre-segmentation tools are restricted to CT scans of potential living liver donors with healthy livers.

Intended Part of the Body:

Images supported for the intended medical indication include the abdominal body part with the liver and related vascular structures (bile ducts, hepatic vein, portal vein, inferior vena cava).

Intended User Profile:

The intended users are radiologists and surgeons.

Intended Use Environment:

The use environment is expected to be in an office environment under typical office conditions in hospitals or medical practices.

Operation Principle:

8 Technological Characteristics Comparison

The design, function, and specifications of MeVis Liver Suite are similar to the identified legally marketed primary predicate and secondary predicate device. The MeVis Liver Suite software combines functionalities of the predicate devices. MeVis Liver Suite allows the medical professionals to display DICOM CT and MR images, and to do a segmentation of internal structures of interest as organs, lesions, vascular structures, including functionality of automatic pre-segmentation that supports the clinicians for contouring.

From a functionality point of view, MeVis Liver Suite and the combination of the predicate devices are substantially equivalent and they cover the same (combined) intended use.

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Key differences in design and performance between MeVis Liver suite and the predicate devices are solely on a technical level.

Device	Indications for Use
Subject DeviceMeVis Liver Suite	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 artery, 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 Al based semi- automatic pre-segmentation tools for liver, hepatic artery, hepatic vein, and portal 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 phaseUsing MeVis Liver Suite, users can evaluate the segmented objects by exploring, calculating, 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, assessment, and treatment decisions.
	MeVis Liver Suite is not intended for the anatomical systems integumentary, skeletal,muscular, lymphatic, respiratory, nervous, reproductive, and cardiovascular (excludinghepatic).
	MeVis Liver Suite does not support the following application areas: real time viewing,diagnostic review, image manipulation, optimization, virtual colonoscopy, and automatic lesiondetection.
	MeVis Liver Suite does not utilize high-resolution displays or display drivers and should not beused as a replacement for a PACS workstation.
	Intended Patient Population:The intended patients for MeVis Liver Suite are oncologic patients or hepatic donor/transplantpatients. CT or MR imaging with contrast agents need to be possible for analysis of vascularstructures inside the liver. The age group for the intended patient population is 18 or older.In addition, the semi-automatic pre-segmentation tools are restricted to CT scans of potentialliving liver donors with healthy livers.
	Intended Part of the Body:Images supported for the intended medical indication include the abdominal body part with theliver and related vascular structures (bile ducts, hepatic artery, hepatic vein, portal vein, inferiorvena cava).
	Intended User Profile:The intended users are radiologists and surgeons.
	Intended Use Environment:The use environment is expected to be in an office environment under typical office conditionsin hospitals or medical practices.
	Operation Principle:The software acts as modality for display of CT or MR imaging data, and for visualization of theimage analysis results on a computer system. MeVis Liver Suite does not come into directcontact or indirect contact with patients or other medical devices.
Primary Predicatedevice:Siemens syngo.CT Liver Analysis(K133643)	syngo.CT Liver Analysis is an image analysis software for CT volume data sets. It analyses theliver and its intrahepatic vessel structures to identify the vascular territories of sub-vesselsystems in the liver. These regions can be evaluated by exploring the volume of the liver andits vascular territories.
	Using syngo.CT Liver Analysis, you can evaluate the liver volume and examine the vessels ofthe liver. The following evaluation tools are provided:
	• Computation and manual correction of liver volumes
	• Computation and manual correction of tumor volumes and extent
	• Computation and manual correction of liver vessel tree structure
	• Computation of territories based on vessel branches
	• Tumor position in relation to vessels (i.e. 3D visualization of liver, tumor and vessels)
	• Manual definition of separation plane proposals
	• Computation of volume of liver parts• Combination of information from different CT and MR phase volumes

	syngo.CT Liver Analysis facilitates reporting by using of appropriate reporting tools, forexample, volume statistics and key image creation. You can use syngo.CT Liver Analysis tocreate a DICOM Structured Report.
SecondaryPredicate device:Radiomics Appv1.0 (Κ173420)	Microsoft Radiomics Advanced Image Contouring v1.0 (Radiomics App) is a software-onlymedical device intended for use by trained radiation oncologists, dosimetrists and physicists toderive optimal organ and tumor contours for input to radiation treatment planning. Supportedimage modalities are Computed Tomography and Magnetic Resonance. Radiomics Appassists in the following scenarios:
	Load, save and display of medical images and contours for treatment evaluation and treatmentplanning.

Creation, transformation, and modification of contours for applications including, but not limitedto: transferring contours to radiotherapy treatment planning systems, aiding adaptive therapy,and archiving contours for patient followup.
Localization and definition of both solid tumors and healthy anatomical structures.
Fusion display of compatible images for treatment planning.
Three-dimensional rendering of medical images and the segmented contours.
Images reviewed using the Radiomics App software should not be used for primary imageinterpretations.
Radiomics App is not for use with digital mammography.

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Table 2 Comparison table for Substantial Equivalence Discussion

Feature/Item	MeVis Liver Suite (subjectdevice)	Primary Predicate device	Secondary Predicate device
Device Name	MeVis Liver Suite	Siemens syngo. CT LiverAnalysis	Radiomics App v1.0
510(k) Number	K232045	K133643	K173420
Indications forUse	See above	See above	See above
Intended Users	The intended users areradiologists and surgeons.	intended for use by physicians	intended for use by trainedradiation oncologists,dosimetrists and physicists toderive optimal organ andtumor contours for input toradiation treatment planning.
Patientpopulation	The intended patients forMeVis Liver Suite areoncologic patients or hepaticdonor/transplant patients.CT or MR imaging withcontrast agents need to bepossible for analysis ofvascular structures inside theliver.The age group for the intendedpatient population is 18 orolder.In addition, the semi-automaticpre-segmentation tools arerestricted to CT scans ofpotential living liver donorswith healthy livers.	Patients requiring analysis ofliver and its intrahepatic vesselstructures.(No restrictions regardinghealthy liver donors, oncologicpatients, ...)	Oncologic patientsDesigned to contour/delineateboth healthy anatomicalstructures as well as lesionssuch as solid tumors.
Intended Partof the Body	Images supported for theintended medical indicationinclude the abdominal bodypart with the liver and relatedvascular structures (bile ducts,hepatic artery, hepatic vein,portal vein, inferior vena cava).	liver and its intrahepatic vesselstructures	No restrictions.
Product Code	JAK	JAK	LLZ
Software	Standalone software	Image analysis software forsyngo.via	Software only medical device
OS	Windows 10 (64-bit)	syngo.via platform	Microsoft Windows
SupportedModalities	DICOM CT and MR	CT and MR	CT and MR
Image importand selection	DICOM images are manuallyselected and imported intoMeVis Liver Suite.	The user has to decide whichanatomical structures need tobe evaluated and on which CTseries the necessarystructures have to besegmented.	The user manually loadsimages into the software.
Segmentationof abdominalorgans	Liver, Stomach, Duodenum, Spleen, Kidney, Gallbladder, and Pancreas	Liver	No restrictions
	Manual segmentation, user-defined manual labelling, and3D visualization.For segmenting the liver, theuser can trigger a semi-automatic pre-segmentationthat creates contours of theliver. The created contourscan be manually corrected withinteractive contouring tools.	Automatic segmentation ofliver, interactive manualcorrection of the resultingcontour.	Assisted and automaticcontouring modes. Creation,transformation, andmodification of contours.
Segmentationof liver relatedvascularstructures	Manual segmentation, user-defined manual labelling, and3D visualization of liver relatedvascular structures (bile ducts,hepatic artery, hepatic vein,portal vein, inferior vena cava).Semi-automatic pre-segmentation for liverrelated vascular structures isavailable: the user can click ina user-identified vessel and	Segmentation of tubularstructures using a semi-automated segmentation ofarterial, portal venous andvenous vascular bile ductstree.The segmentation isperformed by setting seedpoint into vessels entering theliver and the systemautomatically starts to	n/a
	the software detects theconnected vessels. The usercan manually correct, add, ordelete detected vesselsinteractively	segment the wholeintrahepatic vascular object.The user can manually add ordelete vessels.
Segmentationof lesions	Lesions inside and adjacent tothe liverManual segmentation, user-defined manual labelling, and3D visualization of lesionsinside and adjacent to the liver.	Semi-automated segmentationof liver lesions.The user triggers automaticsegmentation by drawing astroke across a lesion at itslargest extent. The user cancorrect the given contour of alesion.	TumorsCreation, transformation, andmodification of contours.Localization and definition ofsolid tumors.
Users canevaluate thesegmentedobjects by	Abdominal organs (i.e., liver,stomach, duodenum, spleen,kidney, gallbladder, pancreas)	Computation and manualcorrection of liver volumes.	Segmentation volume
exploring,calculating,and manuallycorrecting thevolume ofmanuallysegmentedobjects ofinterest	Lesions inside and adjacent tothe liver (according to theiruser defined label)	Computation and manualcorrection of tumor volumesand extent.
	Manually defined parts of theliver "Separation Proposals":"The user can manually defineseparation planes that part theliver into virtual parts. The usermanually labels the parts aseither "resection"/"graft".	Manual definition of separationplane proposals andcomputation of volume of liverparts.
	Manually defined parts of theliver "Vascular territories":Using the user-definedlabelling of vessel branchesthe software can approximate3D visualizations of vascularterritories within the liver andcalculate the appropriatevolumes of the different parts	Computation of territoriesbased on vessel branches bysemi-automated 3D mappingof vascular territories onto livertissue and computation ofvolume of liver parts.
3Dvisualizationsof user-defined(vascular)tumor margins(coloring ofarea - based onuser-definedmarginsizes/distances- between theedges of user-defined lesionsin relation tothe edges ofuser-definedvascularstructures ofthe liver)	The user can manually enterdifferent margin values, whichare used to create color-coded3D visualizations around userdefined lesions.	Tumor position in relation tovessels (i.e. 3D visualization ofliver, tumor and vessels). Themargin size can be choseninteractively for calculatingsafety margin around giventumors.	2d distance measurement
Based on userprovidedvalues,calculation ofliver volume tobody weightratios	The user can enter the weightand height of a patient. Usingthe user-defined manuallycreated segmentations, MeVisLiver Suite can calculate livervolume to body weight ratios(i.e., estimated weight forremnant or graft, body surfacearea, graft to recipient bodyweight ratio, graft to SLV ratio,remnant to body weight ratio).	n/a	n/a
SpatialRegistration	Using a manual spatialregistration of the images, thesegmentations created ondifferent images (i.e. differentCT phases and MRIsequences) can be visualizedtogether. The user canmanually align the images inpairs on top of each otherusing manual rigid registration	Manual rigid registration of CTphase volumes -In case more than one CT (orMR) series has been selected,the series have to be manuallyaligned to each other to matchup the liver anatomy, using themanual alignment tool.	Manual rigid registration.
Reporting	Reporting the results of imageanalysis.	Reporting - All findingsgenerated by the user as wellas calculated volumes and 3Dimages of the structures aresummarized in one report.	n/a

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9 Performance Data

Non-clinical Tests Discussion:

MeVis Liver Suite is the result of combining functionalities of the predicate devices into a single new device. The validation and verification covered successful testing of the performance and functionality of the subject device with respect to conformance to specifications. For validation, human factors and usability engineering has been applied during development, which included a formative evaluation as well as a summative evaluation with the intended user group. In addition, user acceptance tests were conducted in order to get clinical feedback and to demonstrate that MeVis Liver Suite supports clinical workflows.

The performance of the Al pre-segmentation for the liver related vasculature has been validated in a retrospective multi-center performance study:

Liver: For semi-automatic Al pre-segmentation of the liver, MeVis Liver Suite achieved a mean and median DICE score > 85% with a median 95% Hausdorff (HD) value of <2.0 mm. Subgroup analysis indicates that the Al algorithm generalize well across all subgroups. Compared to the reference device Al-Rad Companion Organs RT (K193562), both the DICE score and the HD value were similar in nature and achieved appropriate quality. As it can be seen in Table 3, the achieved performance of the MeVis Liver Suite liver Al pre-segmentation algorithm and reference device are comparable in DICE and Hausdorff Distance.

	DICE	95% HausdorffDistance (HD)
Al-Rad Companion Organs RT (K193562)	Median: 0.85	Median: 2.0 mm
MeVis Liver Suite	Median: 0.98Mean: 0.98	Median: 1.5 mm

Table 3 Performance comparison of liver Al pre-segmentation between MeVis Liver Suite and reference device.

Liver related vasculature: For the semi-automatic Al pre-segmentation of vascular structures HV, PV and HA, bench tests that compare the output of the Al pre-segmentation algorithms with ground truth annotated by qualified experts show that the algorithms performed as expected.

For a representative clinical multi-center dataset, the Al pre-seqmentation results were assessed by 3 board certified surgeons/radiologists using a 5-point Likert scale. The qualitative scoring demonstrates that >80% of all expert scores rated the algorithm results as sufficiently accurate in the context of the clinical use.

Volume calculation of segmentations by MeVis Liver Suite are successfully verified and validated via simulated phantom and clinical test data:

The accuracy of volume is validated by comparing the measured volume of lesions in . digital simulated phantom data with a reference value. The pass criteria for accuracy of volume calculation is fulfilled.

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Clinical test data was used to validate the precision of volume calculation in terms of . repeatability. The pass criteria for precision of volume calculation based on a representative test data set is fulfilled
The results of performance, functional, and validation testing demonstrate that the subject device MeVis Liver Suite meets the specification and intended use, and is substantially equivalent to those of the listed predicate devices.

Clinical Tests Discussion:

N/A - No clinical testing has been conducted to demonstrate substantial equivalence.

10 Conclusion

MeVis Medical Solutions has determined that its device, MeVis Liver Suite, is substantially equivalent to the identified predicate devices listed above. A comparison with the legally marketed predicate devices indicates that it is substantially equivalent to these devices, and that it does not raise any new safety or efficacy concerns. Non-clinical tests demonstrate that the device is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.