GBrain MRI is a fully automated post processing medical device software intended for analyzing known signal hyperintensities in brain MR images. It is not intended for detection of any disease or signal.
GBrain MRI is intended to aid radiologists in quantitatively reporting the extent of FLAIR hyperintensities and or contrast enhancement hyperintensities in the corresponding brain MRI series. GBrain MRI is intended to provide automatic segmentation, quantification, and reporting of derived image metrics.
GBrain MRI should not be used in-lieu of a full evaluation of the patient’s MRI scans. The physician retains the ultimate responsibility for making the final diagnosis and treatment decision.
CAUTION:
To operate GBrain MRI safely and according to its intended use, the following prerequisites must be met:
For the measurement of hyperintensities in T2w FLAIR, GBrain MRI accepts the following MRI series as inputs.
For the measurement of contrast enhancement, GBrain MRI accepts the following MRI series as inputs. Both the pre and post contrast series are necessary for the measurement of contrast enhancement.
The input series should conform to the following parameters for best results.
Deviation from the recommended protocols can result in unexpected GBrain MRI outputs, and those protocols should be validated prior to clinical use.
FLAIR and Post Contrast images must be axial for the device to work correctly.
Parameter | T2-weighted FLAIR | T1-weighted | T1-weighted with contrast |
---|---|---|---|
Manufacturer | Siemens, Philips, GE, Canon | Siemens, Philips, GE, Canon | Siemens, Philips, GE, Canon |
Field Strength | 1.5T or 3T | 1.5T or 3T | 1.5T or 3T |
Scan Mode | 2D, 3D | 2D, 3D | 2D, 3D |
Plane | Axial | Axial or Sagittal | Axial |
Tr (ms) | 5000 – 13,930 ms | 250 – 2212 ms | 250 – 2212 ms |
Te (ms) | 85 – 394 ms | 2.87 – 20 ms | 3.11 – 20 ms |
Ti (ms) | 1800 -2800 ms | 0 – 950 ms | 0 – 950 ms |
Flip Angle | Variable | 90 | 90 |
Fat Suppression | Yes or no | Yes or no | Yes or no |
NEX/NSA | >= 1 | >= 1 | >= 1 |
Slice Thickness | 1 to 5 mm in the axial plane | 1 to 5 mm in the axial plane | 1 to 5 mm in the axial plane |
Spacing between Slices | 1 – 5 mm | 1 – 5 mm | 1 – 5 mm |
Number of Slices | 16 – 240 | 20 – 384 | 16 – 192 |
FOV | 180-240 mm | 180-240 mm | 180-240 mm |
Voxel Spacing | 0.41 – 1.015 | 0.429 – 1.145 | 0.39 – 1.145 |
Needed Metadata | >Patient ID, Patient Age/DOB, and Scan Date (unless this is handled by the AI Marketplace to confirm age appropriateness of patient) | ||
Exclusions | No patients with shunts or other artifact causing items. No patients with resections, or any intracranial surgery No pediatric patients. |
Five outputs will be created by the GBrain MRI device, when processing has been completed. These outputs are sent back to the PACs.
First two segmentation overlays will be created in separate DICOM series.
Additionally reports are created in two formats.
Lastly, since some PACS are unable to open pdf reports, a DICOM secondary capture image is created from the pdf report.
💡 It is imperative for users to review the GBrain MRI annotated DICOM series alongside the patient’s original MRI series. The utilization of volume measurement data should be contingent upon the user’s satisfaction with the accuracy of the segmentation, as indicated by the red overlay produced by the device.
The image below shows a slice in the GBrain FLAIR series, which is a composite image of the patient’s current original scan, the same original image with an annotation for the maximum diameter that was calculated from the segmentations, and the same original scan with all the areas of segmented hyperintensities shown with a semi-transparent red color overlay. The user must agree with the segmented regions in order to use the volumetric and maximum diameter measurement.
The above figure shows the data presented in the GBrain FLAIR series. The total volume is the volume of all FLAIR hyperintensities that the GBrain device found, and were annotated in red for review by the user. The max diameter is the maximum diameter of the largest (in terms of volume) contiguous red region amongst all the regions that were annotated in red.
The image below shows a slice in the GBrain Contrast series, which is a composite image of the patient’s original post contrast scan, the same original scan with an annotation for the maximum diameter that was calculated from the segmentations, and the same original scan with all the areas of contrast enhancement having a semi-transparent red color overlay. The user must agree with the segmented regions in order to use the volumetric and maximum diameter measurement.
The above figure shows the data presented in the GBrain Contrast series. The total volume is the volume of all contrast enhancing regions that the GBrain device found, and were annotated in red for review by the user. The max diameter is the maximum diameter among all the regions in all the slice that were annotated in red.
An example of the pdf report is attached in Appendix A of this document.
CAUTION:
As a software application, the software device does not operate on its own and can only function in conjunction with computer hardware and software. The use of the application is restricted to the specific computer hardware and software outlined in the user documentation. The manufacturer provides the software device solely for its designated medical purpose, and the software itself is considered a medical device. Any other necessary components, hardware, or software required to ensure the workstation’s functionality (e.g., operating systems, network structures, and displays) are not included. This also encompasses potentially required runtime dependencies, even if provided as part of the installation package for user convenience. However, the effects of such components on the medical device are considered and managed.
The capabilities and performance of the software device may be affected by limitations and failures of the hardware, network, or other installed software on the system. Therefore, proper operation and maintenance of the hardware and network are critical. It is necessary to adhere to the manufacturer’s instructions concerning hardware and software specifications, as well as software maintenance.
Installation and setup instructions are specific to each AI Marketplace, since every marketplace has different input and output protocols for studies as well as reports.
Contact Galileo for assistance in installing GBrain MRI for your specific AI Marketplace vendor.
As Galileo GBrain MRI is available on different marketplaces, the list will be updated here
docker run --gpus all -v tmp/input:/workspace/input -v tmp/output/:/workspace/output --cap-add SYS_ADMIN --device /dev/fuse --security-opt apparmor:unconfined gbrain /bin/bash run.sh
--gpus all
option above with --gpus '"device=3"'
A trained IT staff on the customer’s site must follow the following steps to deploy GBrain MRI on their VM. The VM will be provided by the customer. GBrain MRI will only provide the software.
To deploy GBrain MRI with it’s default settings to a VM, do the following:
onprem.sh
Usage: onprem.sh <PACS_AET> <PACS_IP> <PACS_PORT>
To enable SSL for DICOM queries within the customer’s intranet, do the following:
onprem.sh
file sent to you by GBrain MRI and Update the following fields in the Orthanc DICOM server configuration:SslEnabled
: Set this to trueSslCertificate
: Set this to the certificate that you obtained in step 1.
GBrain MRI is designed to run as a Docker container on a Linux based operating system. We recommend that trained IT staff at the customer’s site enable encryption at rest on the host operating system and the storage volume that is mounted to the Docker container.
Here are some encryption systems we recommend. The exact system used should be determined by the IT staff based on best practices as the customer’s site and the specific Linux distribution deployed on the VM.
cryptsetup
. LUKS encrypts the entire block device on the host VM and is available for most Linux distributions.
GBrain MRI is designed to run as a Docker container on a Linux based operating system. We recommend that trained IT staff at the customer’s site enable security scanning tools on the host operating system.
Here are some security scanning systems we recommend. The exact system used should be determined by the IT staff based on best practices as the customer’s site and the specific Linux distribution deployed on the VM.
GBrain MRI recommends that trained IT staff at the customer’s site
Customers must ensure the system is used responsibly by trained facility staff. This includes but may not be limited to:
Customers should maintain proper updates for all devices related to this product.
When deployed to an AI Marketplace, cybersecurity configuration will be handled by the marketplace itself.
When deployed on-prem, customers must provide hardware for the GBrain MRI to run on. The provisioning, cybersecurity, and configuration of this hardware is the responsibility of the customer. The provisioned hardware must meet the following requirements:
A software bill of materials (SBOM) will be provided upon request. Please email info@galileocds.com. Please provide the GBrain MRI version number with your request.
The SBOM is updated automatically for each released version of GBrain MRI and it uses the SPDX 2.2 file format.
When deployed via an AI Marketplace, all the relevant networking and port changes will have already been made by the marketplace when it integrates with the hospital’s IT ecosystem. No additional networking and port changes outside of that will be required for GBrain MRI.
When deployed on-prem, IT staff will need to configure the GBrain MRI DICOM SCP with their PACS with the AE Title “GBRAIN”. The IP address and port for the DICOM SCP will be determined during device onboarding.
GBrain MRI does not store any medical images long term. Those data will only be stored in the customer’s PACS system.GBrain MRI will only temporarily access those data for analysis and report generation purposes. Data, i.e. input MR images, are only stored as long as they are being processed. Once processing is complete the docker container is stopped, and the container along with all data stored within it is deleted.
The customer is strictly responsible for all backups of their medical images on their own PACS.
Customers are also responsible for backups of GBrain MRI logs. When deployed to an AI Marketplace, these backups will be managed by the marketplace itself. When deployed on-prem, we recommend that IT staff set up an recurring background job to do a file system backup of the VM that the device is running on.
GBrain MRI does not have a database and does not rely on persistent data whether deployed to an AI Marketplace or on-prem. The device is stateless. No data outside of the software is required to restore the device back into proper functioning.
When deployed to an AI Marketplace, the marketplace will manage cybersecurity incident response.
When deployed on-prem,GBrain MRI will run on hardware that the customer provides. The security of this device is the responsibility of the customer. The only data source GBrain MRI communicates with is the customer’s PACS. There are no other external connections.
If a cybersecurity incident is detected, we recommend customers monitor the activity on their PACS for abnormalities.
GBrain MRI will log the following events:
To stop using the GBrain MRI:
Security vulnerabilities can be reported to security@galileocds.com. Please include details for reproducing the vulnerability and any other information you think may be relevant.
There are no users accounts for an on-prem installation. The installation should be done by trained IT administrators and PACS administrators from the customer site, with assistance from the Galileo team.
There are no users accounts for an on-prem installation. The installation should be done by trained IT administrators and PACS administrators from the customer site, with assistance from the Galileo team.
Clone the private repository via Git using the following command –
git clone https://github.com/galileo-cds/GBrain
Transfer the MODEL zip files provided by Galileo to the GBrain Repository.
mv GBRAIN_MODELS/* GBrain
Add DICOM Series names based on the hospital location for FLAIR, T1 and T1CE in the following json file –
GBrain/seq-id/hospital_heuristics/general.json
following is an example of how you can add a new series name –
{
"FLAIR": [
"3D CUBE T2 FLAIR AX REF",
"3D T2_FLAIR_SAG_ISO FS POST",
"NEW FLAIR NAME" ## new
],
"T1": [
"AX 3D BRAVO",
"AX 3D T1 BRAVO",
"NEW T1 NAME" ## new
],
"CT1": [
"AX 3D T1 MPRAGE ISO POST",
"AX 3D T1 MPRAGE POST",
"NEW CT1 NAME" ## new
]
}
Note that the values in this json file must match exactly the value that appears in the DICOM SerriesDescription (0008, 103E) header.
Once this is completed, run the following command to complete the installation:
sudo docker build . –tag gbrain
The latest version of the GBrain MRI user manual can be accessed at the following link https://galileocds.com/index.php/GBrainManual/.
Additionally, links to the GBrain MRI user manual are also added to the pdf reports generated by the GBrain device.
The GBrain MRI product label can be accessed…
There are no user accounts associated with an on-premise deployment of GBrain MRI. To delete the GBrain MRI device itself, terminate and wipe the VM that the GBrain MRI device is running on.
User accounts associated with an AI Marketplace deployment are handled by the vendor of the AI Marketplace.
If you have any questions, problems, or comments regarding GBrain MRI functionalities or this user manual, please contact the Customer support team:
Email: customer.support@galileocds.com
This section contains guidelines for users to identify and resolve basic issues that may arise while using GBrain MRI. For additional customer support, please contact customer.support@galileocds.com.
Problem | Cause | Solution |
---|---|---|
Docker run command returns Nvidia driver related error. | Nvidia Docker Driver not installed. | Make sure to install Nvidia Docker Driver. |
No DICOMs found in output folder. | Docker container not mounted to the correct volumes. | Double check that volumes that are mounted onto the Docker container. |
No unresolved anomalies were discovered.
Symbol | Symbol Title / Reference Number | Symbol Definition | Standard Title |
---|---|---|---|
Manufacturer (5.1.1) |
Indicates the medical device manufacturer | ISO 15223-1: 2021-07 Medical Devices – Symbols to be Used with information to be supplied by the manufacturer – Part 1: General requirements | |
Serial Number (5.1.7) |
Indicates the manufacturer’s serial number so that a specific medical device can be identified | ISO 15223-1: 2021-07 Medical Devices – Symbols to be Used with information to be supplied by the manufacturer – Part 1: General requirements | |
Consult instructions for use or consult electronic instructions for use (5.4.3) |
Indicates the need for the user to consult the instructions for use | ISO 15223-1: 2021-07 Medical Devices – Symbols to be Used with information to be supplied by the manufacturer – Part 1: General requirements | |
Prescription use only | Indicates that Federal law restricts the medical device to sale by or on the order of a qualified clinician. | 21 CFR 801.109 Prescription devices |
Term | Definition |
---|---|
Study | An imaging study is a radiologic exam/test/scan uploaded and submitted to the platform for reading, diagnosis, and interpretation by a well-trained and qualified radiologist. |
Modalities | Imaging modalities refer to the different techniques used to create medical images, such as X-ray, CT, and MRI. Each modality uses a different method to produce images and is best suited for certain types of diagnostic exams. |
Medical professionals | Medical personnel and medical professionals are the radiologists, physicians, and clinicians, who receive, ask for, or give feedback about radiologic reports and medical images, in hospitals, and clinics. |
AI Marketplace | An AI Marketplace refers to a marketplace where medical device algorithms from multiple vendors are available for healthcare organizations to try, evaluate, and install for their use. The most common AI Marketplaces are Nuance’s Precision Imaging Network, Sectra’s Amplifier Marketplace, Bayer Calantic Digital Solutions, Siemens Healthineers Digital Marketplace, and the GE Healthcare marketplace. |
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