The intended purpose of the application is to assist a trained specialist in modelling and planning

The Relu Creator is a software intended to assist in the generation of a digital model of the head & neck of the patient. The device also assists in the planning of the treatment on this digital model.

The Relu Creator is a software application that allows trained users to use medical images for:

Components of the software of the Relu Creator, such as the Relu Engine, can be integrated by other manufacturers in their Software as a Medical Device.

The web application can be further used for measurements, diagnosis, monitoring, treatment planning, design, modeling, and reporting.

The Relu Creator is being used to process input 3D images (like DICOM, STL, PLY, OBJ). These images are processed to make a 3D model representing the patient. The Relu Creator is being used by trained professionals to generate a 3D model to represent the patient anatomy.

The Relu Creator is being used by trained professionals to generate a treatment objective and treatment strategy based on the available 3D model of the patient.

Relu Creator is a software program for the management, transfer, and analysis of dental and craniomaxillofacial image information, and can be used to provide design input for dental solutions. It displays and enhances digital images from various sources to support the diagnostic process and treatment planning. It stores and provides these images within the system or across computer systems at different locations.

If the digital model of the patient or treatment planning on the model does not correspond to clinical findings and physical examination, it should not be used for further purposes.

The patient population is including, but not limited to the following:

| Age | All | | Gender | All | | Ethnicity | All | | Treatment needs | Dentistry and CMF Surgery |

The Relu Creator can be used by the following user groups after required training. The web app should be used in conjunction with expert clinical judgment.

The Relu Creator is a software and requires a recent computer. The application is intended to be used in the dental practice, dental lab or equivalent.

The benefit of the application is that it will stimulate better and faster 3D modeling of the patient’s anatomy and treatment planning. This results in more patients that can be helped and treated better at the same time.

To achieve this clinical benefit, the Relu Creator works in a proposal-based paradigm, where the user can check an initial proposal of the anatomy and treatment, and then further correct. Hence the trained specialist can spend more efforts on what the clinician believes matter.

Next to this, the software is designed to allow for other manufacturers to integrate the technology, making it possible for more dentists to access these benefits.

For performance, the medical device allows to accurately visualize, model and measure objects and geometries up to the resolution of the raw input data. No higher accuracy than the input data can be achieved.

For measurements, the device allows to measure up to the voxel resolution for volume data (e.g., CBCT, CT) and up to the triangle resolution for mesh data (e.g., STL, PLY). The degree of accuracy of the measurement function is therefore the same as the degree of accuracy of the raw input data.

For safety, the results of the application are always subject to the decision of the clinician, therefore being inherently safe.

Manufacturers integrating the Relu Creator are responsible for the safety and risk management in their own Medical Device.

Input: CBCT Scan (3D Volume)

Output: A mask indicating where each structure is present in the image (3D Volume).

Limitations: No limitations in terms of CBCT scanners, resolutions, or patient populations. The structure must be present in the provided image to generate a proposal. The masks should be reviewed before use.

Performance Specifications:

| Mandible | Avg IoU > 90% | | Skull | Avg IoU > 85% | | Dentition | Avg IoU > 90% | | Mandibular Canal | Avg Recall > 90% | | Pharynx | Avg IoU > 90 % | | Maxillary Sinuses | Avg IoU > 90% |

Information presented to the user:

Users are presented with the information in a highlighted format on a scan viewer. The segmentation area is highlighted for the user’s review and adjustment. There are no applicable units in this process.

Level of User Interaction:

The required interaction for the user is at the final step, the user should review whether the anatomy is correctly indicated.

Input: Intra Oral Scan (3D Mesh)

Output: A Mask on the faces of the mesh indicating which tooth is present where on the Mesh. The mask on the teeth is according to the FDI number, all non-teeth elements (gingiva, base) are classified as background.

Limitations: No limitations in terms of used Intra Oral Scanner, resolution or patient population. Masks should be reviewed before use.

Performance Specifications: Average Intersection Over Union > 90%

Information presented to the user:

Users are presented with the information in a highlighted format on a scan viewer. The segmentation area is highlighted for the user’s review and adjustment. There are no applicable units in this process.

Level of user interaction:

The required interaction for the user is at the final step, the user should review whether the anatomy is correctly indicated.

Input: Intra Oral Scan (3D Mesh) & CBCT (3D Volume) or Facial Scan (3D Mesh) & CBCT (3D Volume)

Output: A transformation matrix that transforms the mesh to the coordinate system of the cbct

Limitations:
​For Intra Oral Scan and CBCT
No limitations in terms of used Intra Oral Scanner, or CBCT device. The algorithm relies on teeth being present in the CBCT and IOS to perform the registration, edentulous cases are not supported. The algorithm is designed for registering data from the same patient at similar times, and does not accommodate chang des such as newly added bridges, crowns, or recently extracted/moved teeth.

For Facial Scan and CBCT
No limitations in terms of used Facial Scanner, or CBCT device. The algorithm relies on the face being visible in the CBCT, this implies that only large FOVs are supported by the algorithm.

Performance Specifications: For Intra Oral Scan & CBCT an average RMSE < 0.5mm when comparing to ground truth. For CBCT and Facial Scan an average RMSE < 5.5 mm when comparing to ground truth.

Information presented to the user:

Users are presented with the information in a highlighted format on a scan viewer. They can review the overlay of the mesh on the CBCT.

Level of user interaction:

The required interaction for the user is at the final step, the user should review whether the anatomy is correctly indicated.

If the company decides the Relu Creator SAMD is discontinued, this will be announced via e-mail 6 months before the last service date. The user should migrate all of its data from the Relu® Creator.

All data is retained for a period of 10 years after the discontinuity of services. After this date, all data is deleted according to industry standards/ privacy regulations.

Any serious accident resulting from the use of the medical device should be notified to the manufacturer and the competent authority of the member state. The contact details of the competent authority can be found via the following URL: https://www.ema.europa.eu/en/partners-networks/eu-partners/eu-member-states/national-competent-authorities-human.

The technical minimum requirements (to run the software as intended) concerns the hardware, IT network characteristics and IT security measures, which are listed below. This also includes protection against unauthorized access.

The technical minimum requirements (to run the software as intended) concerns the hardware, IT network characteristics and IT security measures, which are listed below. This also includes protection against unauthorized access.

| Hardware | The CPU should be at least intel i7, AMD Ryzen 7 or Apple M1. The RAM should be at least 16GB. The GPU should have at least 4GB of memory. | | Software | macOS version 12 or later Windows 11 or later Chrome version 97 or equivalent | | IT Infrastructure | The network should have an internet connection of at least 20Mbps. The network should be protected by means of a firewall. |

The device does not require any installation as it is web-based. The device will be updated automatically, as it is web-based. The latest version will be made accessible in the browser of the user by browsing to the medical device.

Requirements regarding training or The user is required to get basic training regarding the segmentation tools and treatment planning tools, before safely making use of the software. Such mandatory training will be made available online in the format of a User Manual showcasing the different functionality to the user.

Manufacturers integrating parts of the Relu Creator are responsible for training and qualification of their end-users.

The user manual can be publicly accessed via https://user-manual.creator.relu.ai/user-manual/index.html.

Input

The device is meant to be used with CBCT scans and/or Intra Oral and/or Facial Scans. Scanning protocols are left to the discretion of the user; however, we recommend that industry standards are referenced and followed, and are selected to be appropriate for the intended use.

The 3D and 2D visualization should always be verified on left-right orientation, to see that the images are not mirrored by the trained user before any further use.

The measurements should always be verified for accuracy by the trained user before any further use.

Output

Relu Creator should only be used by trained medical professionals. We recommend that all users participate in digital trainings offered by Relu. The AI Proposals should always be verified by the trained user before any further use.

Any exports made with the applications should be verified for accuracy with the image visualized in the web application or another software before any further use.

Based on the Risk Management and Clinical Evaluation, there are no unacceptable residual risks, nor undesirable side-effects. The overall residual risk and the benefit-risk ratio are considered acceptable.

The user is required to complete basic training on the segmentation and treatment planning tools before safely using the software. Training is provided online as:

Manufacturers integrating the Relu® Creator are responsible for training their end-users.

To maintain the highest level of security for your sensitive medical data, it is crucial to follow several cybersecurity best practices.

Create a strong, unique password for your account by combining letters, numbers, and special characters, and regularly update this password to prevent unauthorized access. Additionally, it is advisable to avoid using the application over public Wi-Fi networks, as they may lack sufficient security, posing a risk to your personal information. Also, remain alert to phishing attempts: never share your login credentials via email or over the phone, and ensure that you are always logging in through the official website of our medical application.

If you become aware of an information security event or incident, possible incident, imminent incident, unauthorized access, policy violation, security weakness, or suspicious activity, then please immediately report the information using one of the following communication channels:

Reporters should act as a good witness and behave as if they are reporting a crime. Reports should include specific details about what has been observed or discovered.

| | Weblink | | | Caution, please consult the instructions for use and the accompanying documentation | | | Consult instructions for use or consult electronic instructions for use | | | Medical Device | | | Unique Device Identifier | | | Legal Manufacturer | | | Date of Manufacture |

| | Mail: [email protected]
Website: https://www.relu.eu/ |

| 1 | Initial Version | Adriaan Van Gerven | | 2 | Added Incident Response Plan to the IFU and Added Section on Algorithms with limitations | Adriaan Van Gerven | | 3 | Merged IFU US and IFU EU. Removed print version, extract about box. Removed reference to desktop installation. | Adriaan Van Gerven | | 4 | Removed about box, now referenced directly in the Relu® Creator editor application. Made warning more prominent, updated list of symbols and removed youtube links. | Thomas Beznik, Adriaan Van Gerven |