Intended purpose
| Version 1.2 | |
| Date 2024.11.26 | |
Synaptiq Technologies SRL | CE Placeholder (01)4270004355802(11)yymmdd(8012)v1.2.0 |
| Risk Class Mediq RT is a class IIa medical device in accordance with Regulation (EU) 2017/745. | |
| EMDN Code Z11010292: Instruments for radiotherapy simulation | |
Intended Use
Mediq RT is a software as a medical device intended to assist radiation oncologists and medical physicists in generating the contours of organs-at-risk (OARs) and clinical target volumes (CTVs) on 3D Computer Tomography (CT) images of cancer patients with an indication for radiotherapy treatment. Mediq RT uses an automatic AI-based segmentation algorithm capable to delineate regions of interest for all important anatomical sites: head and neck, thorax, abdomen and pelvis.
Intended Medical Indication
Mediq RT automatically segments organs-at-risk (OARs) and clinical target volumes (CTVs) using CT scans for radiotherapy treatment planning. It assists radiation oncologists and medical physicists in contouring, reviewing, and editing these regions of interest. The software is designed for a broad spectrum of malignancies, where precise radiation delivery is essential to maximize tumor control and minimize damage to surrounding healthy tissues.
Conditions and Diseases Targeted
This software is applicable for use in patients diagnosed with various forms of cancer, including, but not limited to:
- Brain tumours (glioblastoma, astrocytoma, etc.)
- Head and neck tumors (oral cavity cancer, laryngeal cancer, nasopharynx cancer, etc.)
- Thoracic tumors (breast cancer, lung cancer, esophageal cancer, etc.)
- Abdominal tumours (pancreatic cancer, stomach cancer, etc.)
- Pelvic tumours (bladder cancer, prostate cancer, cervical cancer, uterine cancer, etc.)
- Metastatic tumors (bone metastases, brain metastases, etc.)
Exclusion Criteria
It is crucial to acknowledge certain exclusion criteria to ensure the safe and effective use of the software
- Patients with large metal implants (hip prothesis) or motion artefacts in the imaging area: Metals can significantly distort the medical images, potentially leading to inaccurate contouring by the software.
- Paediatric Patients: The software is primarily designed for adult anatomy and its accuracy has not been validated for pediatric patients. Special consideration and validation are required before extending its use to this demographic.
- Patients with Poor Quality Imaging: Adequate image quality is paramount for the software's performance. Patients with scans of suboptimal quality due to motion artifacts, insufficient contrast, or other issues may not be suitable for automated contouring using this software.
- Cases Requiring Highly Individualised Contouring: Some complex cases might require highly individualized contouring based on unique anatomical or clinical considerations, which might be beyond the software's current capabilities.
While the AI-based contouring software serves as a transformative tool in enhancing the efficiency, precision, and consistency of radiotherapy planning, its application should be carefully considered in line with the above criteria. It is intended to augment the expertise of the clinical team, with all automatically generated contours necessitating thorough review and validation by qualified radiation oncology professionals prior to finalizing the treatment plan.
Characterization of User Profile
The user profile encompasses medical professionals that are highly trained in the fields of medicine, physics, or dosimetry, with a solid foundation in the science of radiation therapy. They are represented by radiation oncologists and medical physicists.
In order to include the software in the clinical workflow, tailored training sessions will be conducted prior to software usage. This training covers the entire workflow, from the CT simulation to the Mediq RT software and back to the clinic's treatment planning system (TPS). The software functionalities, as outlined in this user manual, are also explained.
Characterization of Patient Population
Mediq RT uses 3D CT scans of adult cancer patients and provides automatic segmentation of the clinical target volume and OARs. This software is to be used for cancer patients above 18 year that have an indication for radiation therapy received from the attending radiation oncologist. Mediq RT should not be used for patients below the age of 18.
Characterization of Use Environment (Clinical Setting)
The typical use environment for this medical device is a contouring/treatment planning room located within the radiation oncology department of a clinic or hospital. This is a space with restricted access for the patients, generally calm and quiet, facilitating concentration and detailed work. The lighting can be adjusted to the optimal setting since radiation oncologists use workstations with modern screens, smartphone devices or tablets. This environment is distinct from more chaotic settings like emergency wards.
The software and hardware requirements for using Mediq RT are described in the System Requirements section below.
Exclusions
- Non-Medical Personnel: The device should not be operated by individuals without medical training, such as patients or unqualified staff, due to the specialized knowledge required to interpret and utilize the software effectively.
- Untrained Medical Staff: Healthcare professionals who have not received specific training on the device should not use it until they have completed the necessary instruction and demonstrated proficiency, ensuring safe and effective operation.
- Unapproved Clinical Scenarios: The device should not be used for clinical scenarios or patient populations for which it has not been approved or validated, such as treatments outside its intended scope (e.g., non-oncology applications).
- Unsupported Hardware or Software Platforms: Avoid using the device on hardware or software platforms that have not been explicitly supported or recommended by the manufacturer, as this could compromise functionality and safety.
Clinical Benefits
Mediq RT performs automatic segmentation of organs-at-risk and clinical target volumes from CT scans to support radiotherapy treatment planning. It assists the radiation oncologist in contouring, reviewing and editing these regions of interest.
Performance Characteristics
The final average (across all organs-at-risk) quantitative metrics obtained on the validation dataset, rounded to two decimals, can be observed below:
- Detection False Negative Rate (DFNR) = 0.26%
- Volumetric Dice Coefficient (vDSC) = 86.09%
- Surface Dice Coefficient (sDSC) = 80.27%
- Hausdorff Distance 95th percentile (HD95) = 8.41mm
- Added Path Length (APL) = 389.72cm
Combination with Other Products
The Mediq RT software has no accessories. However, it can be used in combination with other products, as described below:
- Hardware: Mediq RT is not delivered with any hardware and runs on the client internal system / system provided by the client. Normal computer hardware such as a mouse, keyboard, screen etc. are needed to interact with the software. Mediq RT is used indirectly in combination with Computer Tomography machines by processing their generated 3D volumes as DICOM files.
- Software: Mediq RT interacts with treatment planning systems (TPS) as well as picture archiving and communication systems (PACS) of various vendors, using the standardized DICOM protocol. Our medical viewer interacts within the user environment as a browser application, being executed inside its sandbox environment.
Safety Information
Contraindications
Mediq RT should not be used for patients below the age of 18. Mediq RT should not be used for patients without an indication for radiotherapy.
Warnings
All contours must be reviewed, corrected (if needed), and accepted by the radiation oncologist (or the personnel involved in the contouring process) after they are generated by the AI.
System Requirements
Mediq RT can run as a cloud-based Software-as-a-Service (SaaS) or self-hosted on the hospital's premises.
Mediq Viewer
For the user workstations using the Mediq Viewer web platform to generate, revise and adjust the contours, the recommended specifications are as follows:
- At least 4 GB of RAM
- A processor with a minimum of 2 cores, running at a frequency of at least 2 GHz
- At least 20 GB disk storage space
- Windows 10/MacOS 10 operating system or higher
- The latest version of Google Chrome, Microsoft Edge, or Safari browser with Javascript enabled
- A stable internet connection with a minimum speed of 50 Mbps
The Mediq Viewer web platform can also be accessed and used from an Internet-enabled mobile device such as tablets or smartphones, using Google Chrome, Microsoft Edge or Safari. For this particulare usage of the product, it is recommended to be used on a tablet equivalent to at least the iPad Pro 2021 generation.
All the above recommendations are orientative in nature, and the software may be able to run on equivalent or lower specifications. This may, however, incur penalties in performance such as fewer frames per second, occasional lack of responsiveness, and may impact the user experience negatively.
Synaptiq does not take responsibility for potential security issues or graphical glitches that can be attributed to running the Mediq Viewer platform on an outdated version of Google Chrome, Microsoft Edge or Safari, or using other browsers that are not explicitly mentioned in this section.
Mediq Agent
For the clients which integrate Mediq RT into their clinical pipeline, a workstation / virtual machine is required, with the recommended specifications as follows:
- At least 2 GB of RAM
- A processor with a minimum of 2 cores, running at a frequency of at least 2 GHz
- At least 25 GB disk storage space
- Ubuntu 22.04 or newer
- Network access to internal hospital network and Internet
The system would be required to be kept running for the whole time the Mediq RT software is used.
Mediq Server
For the clients that opt for a self-hosted integration of Mediq RT inside the hospital's premises, an extra compute workstation is needed, having the following technical requirements:
- At least 16 GB of RAM.
- A processor with a minimum of 8 cores, running at a frequency of at least 3.8 GHz.
- At least 512 GB disk storage space.
- Ubuntu 22.04 operating system.
- A dedicated NVIDIA graphics card (GPU) having at least 20GB of dedicated VRAM.
- A high-speed network connection with a minimum speed of 1000 Mbps.
The system would be required to run demanding machine learning inference pipelines, as well as other computer vision procedures. Cuda 11.8 or higher is required, as well as a graphics card that is compatible with the latest PyTorch 2.0+ version.
IT-security Measures
The security and privacy of the medical data is ensured through comprehensive IT security measures :
- Data at rest is encrypted to prevent unauthorized access, while data in transit is secured with advanced encryption technologies.
- User passwords are hashed before being sent through the network.
- Sensitive patient information benefits from end-to-end encryption for added confidentiality. This essentially means that nobody, not even us, can access the data, even if we wanted to.
- The security of an user account can be enhanced by enabling multi-factor authentication.
- Furthermore, only authorized devices can access the virtual machines through certificate-based SSH authentication wherever possible, providing an extra layer of security.
The security and privacy of an account is as strong as the password used for authentication. The user is strongly advised to follow good practices for setting passwords such as: choosing an unguessable password, not sharing the password with anyone, using a password manager, etc.
Installation
Mediq Viewer
The Mediq Viewer is a web platform, and thus does not require specific installation, other than a web browser. Due to minor difference between browsers, we recommend updating to the the latest version of Google Chrome, Safari or Microsoft Edge web browser prior to using the viewer.
Mediq Agent
The installation and maintenance for the Mediq Agent system is managed by Synaptiq. The user may not add, remove, or alter in any way the hardware or the software systems of the agent machine without explicit approval from the Synaptiq support team.
Synaptiq does not provide any guarantees over any changes made by the user to the agent machine.
Safety and Maintenance
User account management
The management of user accounts is described in this section.
Access control
Access control measures can be employed from the Mediq Browser interface by an account marked as 'Admin', by clicking the “Wrench” icon on the top bar. An admin user may modify the rights of any given member to the current datastore, as well as revoke access completely.
An external account may not be added to the member list. For adding an account to the member list, please contact the Synaptiq product representative directly or by e-mail support@synaptiq.io.
Deployment of new versions
New versions are deployed and integrated periodically by the Synaptiq team. The web application will serve the latest version automatically, containing the most recent security and functional updates, without requiring additional actions from the user. The current version can be checked from the About section inside the top bar menu.
Reporting of errors and other clinical incidents
Errors or malfunctions inside the software may be reported by contacting the Synaptiq product representative directly or by e-mail support@synaptiq.io.
Any serious incident that occurs in connection with the use of this device should be reported to the manufacturer and to the competent authority of the Member State where you, as the user and/or patient, are located.