(109 days)
Yes
The document explicitly states that the device provides "AI based semi-automatic pre-segmentation tools" and refers to "Al networks" and "Al pre-segmentation algorithms".
No
Explanation: This device is an image analysis software used for visualization, segmentation, and volumetric calculations for diagnostic and treatment planning purposes, but it does not directly apply therapy or provide a therapeutic effect. It serves as a tool to assist physicians in making treatment decisions.
Yes
MeVis Liver Suite is an image analysis software for visualization of hepatic imaging studies, supporting physicians in evaluating the liver for treatment planning, preoperative evaluation, and post-procedure follow-up. It provides tools for manual segmentation, 3D visualization, and AI-based semi-automatic pre-segmentation of organs and vascular structures, as well as calculating volumes and ratios, which are all activities associated with diagnosis or assessment of a medical condition. It explicitly states it supports "evaluating the liver" for various clinical purposes, placing it within the realm of diagnostic devices.
Yes
The device is described as a "standalone software application" that can be installed on a standard PC running Windows 10, and its function is image analysis and visualization based on DICOM data. There is no mention of proprietary hardware or hardware components included with the device.
Based on the provided information, MeVis Liver Suite is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- MeVis Liver Suite's Function: MeVis Liver Suite analyzes medical images (CT and MR scans) of the liver and related structures. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it's for "visualization of hepatic imaging studies" and supports physicians in "evaluating the liver, related vascular anatomy, and the volume of liver and liver vascular territories". This is image analysis, not in vitro testing.
Therefore, MeVis Liver Suite falls under the category of medical image analysis software, not an IVD.
No
The letter does not explicitly state that the FDA has reviewed, approved, or cleared a PCCP for this specific device. The 'Control Plan Authorized (PCCP)' section is marked 'Not Found'.
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
JAK
Device Description
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 AI 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 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 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.
Segmentation 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:
- Freehand contouring
- 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:
- Freehand drawing and freehand contouring
- Region Growing
- Edit and label 3D tree
. Lesions inside and adjacent to the liver
MeVis Liver Suite is intended to be used to manually segment, visualize, and label user identified lesions inside and adjacent to the liver using:
- Freehand contouring
MeVis Liver Suite does not identify or highlight lesions or other abnormalities.
Additionally, the user can use AI based semi-automatic pre-segmentation of liver and liver related vascular structures to create a segmentation proposal. The semi-automatic presegmentation uses locked/non adaptive AI networks.
Semi-automatic pre-segmentation of the liver
- Supported modalities
- CT, contrast enhanced late-venous and venous phase
- Limitations
- Only intended for living donor liver transplantation cases (healthy livers)
Semi-automatic pre-segmentation for liver related vascular structures
- Supported modalities
- 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
- 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: - Abdominal organs (i.e., liver, stomach, duodenum, spleen, kidney, gallbladder, pancreas)
- Lesions inside and adjacent to the liver
- Manually defined parts of the liver
- . "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 segmentation 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)
- 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")
- The distance of vascular structures to user selected lesions can be visualized with colored 3D visualizations:
- 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
- Body Surface Area
- Graft to Recipient Body Weight Ratio
- Graft to Standard Liver Volume (SLV) Ratio
- Remnant Volume to Body Weight Ratio
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).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
CT, MR
Anatomical Site
abdominal body part with the liver and related vascular structures (bile ducts, hepatic artery, hepatic vein, portal vein, inferior vena cava).
Indicated Patient Age Range
18 or older.
Intended User / Care Setting
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.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Liver: For semi-automatic AI pre-segmentation of the liver, MeVis Liver Suite achieved a mean and median DICE score > 85% with a median 95% Hausdorff (HD) value of 80% of all expert scores rated the algorithm results as sufficiently accurate in the context of the clinical use.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 AI pre-segmentation for the liver related vasculature has been validated in a retrospective multi-center performance study:
Liver: For semi-automatic AI pre-segmentation of the liver, MeVis Liver Suite achieved a mean and median DICE score > 85% with a median 95% Hausdorff (HD) value of 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.
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
| DICE | 95% Hausdorff Distance (HD) | |
|---|---|---|
| AI-Rad Companion Organs RT (K193562) | Median: 0.85 | Median: 2.0 mm |
| MeVis Liver Suite | Median: 0.98 Mean: 0.98 | Median: 1.5 mm |
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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).
1
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
2
Indications for Use
510(k) Number (if known) K232045
Device Name MeVis Liver Suite
Indications for Use (Describe)
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.
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
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.
3
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.
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 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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4
K232045 510(k) Summary
1 Submitter
| Submitted Name: | MeVis Medical Solutions AG
Caroline-Herschel-Straße 1
28359 Bremen
Germany |
|---------------------------------------|-------------------------------------------------------------------------------------|
| Establishment Name: | MeVis Medical Solutions AG |
| Establishment
Registration Number: | 3010601176 |
| Date Prepared: | 07/10/2023 |
| Contact Person: | Rolf Rzodeczko
Manager 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 |
5
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
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
1 Reference device for liver Al pre-seqmentation performance acceptance criteria
6
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.
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
Me/is 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 ●
7
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"
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")
- o The distance of vascular structures to user selected lesions can be visualized with colored 3D visualizations:
- 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 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.
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 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.
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 (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:
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 or indirect contact with patients or other medical devices.
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 Device | |
| MeVis 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 phase
Using 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 (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 artery, 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:
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 or indirect contact with patients or other medical devices. |
| Primary Predicate
device:
Siemens syngo.
CT Liver Analysis
(K133643) | syngo.CT Liver Analysis is an image analysis software for CT volume data sets. It analyses the
liver and its intrahepatic vessel structures to identify the vascular territories of sub-vessel
systems in the liver. These regions can be evaluated by exploring the volume of the liver and
its vascular territories. |
| | Using syngo.CT Liver Analysis, you can evaluate the liver volume and examine the vessels of
the 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, for
example, volume statistics and key image creation. You can use syngo.CT Liver Analysis to
create a DICOM Structured Report. |
| Secondary
Predicate device:
Radiomics App
v1.0 (Κ173420) | Microsoft Radiomics Advanced Image Contouring v1.0 (Radiomics App) is a software-only
medical device intended for use by trained radiation oncologists, dosimetrists and physicists to
derive optimal organ and tumor contours for input to radiation treatment planning. Supported
image modalities are Computed Tomography and Magnetic Resonance. Radiomics App
assists in the following scenarios: |
| | Load, save and display of medical images and contours for treatment evaluation and treatment
planning. |
| | |
| Creation, transformation, and modification of contours for applications including, but not limited
to: 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 image
interpretations. | |
| 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 (subject
device) | Primary Predicate device | Secondary Predicate device |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | MeVis Liver Suite | Siemens syngo. CT Liver
Analysis | Radiomics App v1.0 |
| 510(k) Number | K232045 | K133643 | K173420 |
| Indications for
Use | See above | See above | See above |
| Intended Users | The intended users are
radiologists and surgeons. | intended for use by physicians | intended for use by trained
radiation oncologists,
dosimetrists and physicists to
derive optimal organ and
tumor contours for input to
radiation treatment planning. |
| 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. | Patients requiring analysis of
liver and its intrahepatic vessel
structures.
(No restrictions regarding
healthy liver donors, oncologic
patients, ...) | Oncologic patients
Designed to contour/delineate
both healthy anatomical
structures as well as lesions
such as solid tumors. |
| 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 artery, hepatic vein,
portal vein, inferior vena cava). | liver and its intrahepatic vessel
structures | No restrictions. |
| Product Code | JAK | JAK | LLZ |
| Software | Standalone software | Image analysis software for
syngo.via | Software only medical device |
| OS | Windows 10 (64-bit) | syngo.via platform | Microsoft Windows |
| Supported
Modalities | DICOM CT and MR | CT and MR | CT and MR |
| Image import
and selection | DICOM images are manually
selected and imported into
MeVis Liver Suite. | The user has to decide which
anatomical structures need to
be evaluated and on which CT
series the necessary
structures have to be
segmented. | The user manually loads
images into the software. |
| Segmentation
of abdominal
organs | Liver, Stomach, Duodenum, Spleen, Kidney, Gallbladder, and Pancreas | Liver | No restrictions |
| | Manual segmentation, user-
defined manual labelling, and
3D visualization.
For segmenting the liver, the
user can trigger a semi-
automatic pre-segmentation
that creates contours of the
liver. The created contours
can be manually corrected with
interactive contouring tools. | Automatic segmentation of
liver, interactive manual
correction of the resulting
contour. | Assisted and automatic
contouring modes. Creation,
transformation, and
modification of contours. |
| Segmentation
of liver related
vascular
structures | Manual segmentation, user-
defined manual labelling, and
3D visualization of liver related
vascular structures (bile ducts,
hepatic artery, hepatic vein,
portal vein, inferior vena cava).
Semi-automatic pre-
segmentation for liver
related vascular structures is
available: the user can click in
a user-identified vessel and | Segmentation of tubular
structures using a semi-
automated segmentation of
arterial, portal venous and
venous vascular bile ducts
tree.
The segmentation is
performed by setting seed
point into vessels entering the
liver and the system
automatically starts to | n/a |
| | the software detects the
connected vessels. The user
can manually correct, add, or
delete detected vessels
interactively | segment the whole
intrahepatic vascular object.
The user can manually add or
delete vessels. | |
| Segmentation
of lesions | Lesions inside and adjacent to
the liver
Manual segmentation, user-
defined manual labelling, and
3D visualization of lesions
inside and adjacent to the liver. | Semi-automated segmentation
of liver lesions.
The user triggers automatic
segmentation by drawing a
stroke across a lesion at its
largest extent. The user can
correct the given contour of a
lesion. | Tumors
Creation, transformation, and
modification of contours.
Localization and definition of
solid tumors. |
| Users can
evaluate the
segmented
objects by | Abdominal organs (i.e., liver,
stomach, duodenum, spleen,
kidney, gallbladder, pancreas) | Computation and manual
correction of liver volumes. | Segmentation volume |
| exploring,
calculating,
and manually
correcting the
volume of
manually
segmented
objects of
interest | Lesions inside and adjacent to
the liver (according to their
user defined label) | Computation and manual
correction of tumor volumes
and extent. | |
| | Manually defined parts of the
liver "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". | Manual definition of separation
plane proposals and
computation of volume of liver
parts. | |
| | Manually defined parts of the
liver "Vascular territories":
Using the user-defined
labelling of vessel branches
the software can approximate
3D visualizations of vascular
territories within the liver and
calculate the appropriate
volumes of the different parts | Computation of territories
based on vessel branches by
semi-automated 3D mapping
of vascular territories onto liver
tissue and computation of
volume of liver parts. | |
| 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) | The user can manually enter
different margin values, which
are used to create color-coded
3D visualizations around user
defined lesions. | Tumor position in relation to
vessels (i.e. 3D visualization of
liver, tumor and vessels). The
margin size can be chosen
interactively for calculating
safety margin around given
tumors. | 2d distance measurement |
| Based on user
provided
values,
calculation of
liver volume to
body weight
ratios | The user can enter the weight
and height of a patient. Using
the user-defined manually
created segmentations, MeVis
Liver Suite can calculate 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). | n/a | n/a |
| Spatial
Registration | Using a manual spatial
registration of the images, the
segmentations created on
different images (i.e. different
CT phases and MRI
sequences) can be visualized
together. The user can
manually align the images in
pairs on top of each other
using manual rigid registration | Manual rigid registration of CT
phase volumes -
In case more than one CT (or
MR) series has been selected,
the series have to be manually
aligned to each other to match
up the liver anatomy, using the
manual alignment tool. | Manual rigid registration. |
| Reporting | Reporting the results of image
analysis. | Reporting - All findings
generated by the user as well
as calculated volumes and 3D
images of the structures are
summarized 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 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.