This User Guide provides step-by-step instruction for use of the Lumi Prepare and Lumi Segment software. More details can be found in the Instructions for Use.

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Terminology

Lumi does not contain true Holography, which involves recording and reconstructing the light field of an object to create a true 3D image. Lumi uses stereoscopic image visualization through a stereoscopic head mounted display (Microsoft HoloLens 2). The Microsoft HoloLens 2 displays content at a fixed focal plane and does not have Holograms as 3D output. All technical performance testing has been performed according to the correct technological definitions (stereoscopic image visualization trough a stereoscopic head mounted display). However, in this User Guide the term ‘Hologram’ is still used for practical purposes, not following formal hologram definition, to represent the stereoscopic image of the patient, along with all its constituent parts, like the scan and 3D surface models visualized through the stereoscopic head mounted display.

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Intended Use

Lumi Prepare is intended for the preoperative investigation of medical scans and 3D models of anatomical and pathological structures of the head, with capabilities for shape editing of the 3D models and virtual surgical treatment planning, both on 2D displays and in Augmented Reality.

Lumi Segment is intended to generate 3D models from medical image data of the head, utilizing AI algorithms for automatic segmentation as well as manual segmentation functionalities. These models can be used for preoperative investigation of potential surgical treatment steps in conjunction with Lumi Prepare.

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Indications for Use

Lumi Prepare is intended to be used by qualified surgeons, surgical residents, or medical professionals authorized by a hospital to review or prepare medical imaging data for surgical procedures. Lumi Segment is intended to be used specifically by qualified neurosurgeons, neurosurgical residents, or medical professionals authorized by a hospital to review or prepare medical imaging data for neurosurgical procedures.

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Each user must be trained before use. The software is not intended for diagnostic use. All pathology visualized or segmented with the software must pertain to conditions that have been previously diagnosed.

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Lumi Prepare supports the conversion of Magnetic Resonance Imaging (MRI) and/or Computed Tomography (CT) scans of adult patients into 3D models. Supported imaging types include:

• Contrast-enhanced T1 MRI scans (T1c Segmentation Function).

• Non-contrast-enhanced CT scans (CTnc Segmentation Function, Manual Segmentation).

• Contrast-enhanced CT scans (Manual Segmentation).

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The T1c Segmentation Function is indicated for use in patients with a single intracranial contrast-enhancing tumor diagnosed by a neuroradiologist or neurosurgeon. The tumor must meet the following criteria:

• Minimum volume of 2.0 cc (0.1 in³) and maximum volume of 100 cc (6.1 in³).

• Minimum diameter of 15 mm (0.6 inches) and maximum diameter of 75 mm (3.0 inches) in any direction.

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Contra indications for Use

• Diagnostic purposes

• Patients under 18 years of age

• Use during intraoperative surgical steps

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Warnings

• Patient health information and/or meta-data that might lead to patient identification cannot be uploaded in Lumi Prepare and Lumi Segment. Only anonymized patient data can be uploaded.

• The output data provided by Lumi Prepare and Lumi Segment must be subject to careful expert assessment. Segmentations should thereby always be verified by a qualified user in Lumi Prepare and Lumi Segment by outline analysis on the source medical image, since false positive and negative segmentation regions can occur. The user is responsible for the adequate evaluation of the results.

• The segmentation functions that create 3D Models from 2D data do only support the usage of T1 Magnetic Resonance Images (MRI) or Computer Tomography (CT) images.

• It is recommended to use the software within a hardware and/or a network environment in which cybersecurity controls have been implemented including anti-virus and use of firewall.

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Cybersecurity

To ensure comprehensive protection, the following cybersecurity measures are implemented:

• Access Control and User Session Management: SSL connection is enforced with TLS 1.2, furthermore users are automatically logged out of the website after 60 minutes of inactivity.

• Anti-malware: Lumi Prepare and Lumi Segment uses Azure’s built-in security features, including Microsoft Defender for Cloud, to protect against malware and other threats.

• Audit logfiles: Lumi Prepare and Lumi Segment collects logfiles on both user and system level to capture activities and events that occur within Lumi Prepare and Lumi Segment. These logfiles are monitored and reviewed to detect unauthorized access, security breaches, or unusual activities.

• Data Encryption: Data at rest and Cached data is AES-256 encrypted.

• Data Transmission Security: Data in transit is encrypted using HTTPS with TLS 1.2.

• Firewalls: Network security is enforced via Azure’s Virtual Networks, IP whitelisting, and Network Security Groups (NSGs) to control inbound and outbound traffic.

• Levels of authorization: Authorized clinical Users can access designated asset groups according to their authorized Role-Based Access Control (RBAC) permissions.

• Login in HoloLens 2: Users can login in the HoloLens 2 with their username and password. This can be changed to login with a pin code or with the use of biometric authentication (iris scan).

• Password requirements for Administrators: Password policies adhere to Azure’s standards, requiring among others MFA for access to critical systems by administrators.

• Security event detection: The LumiNE software uses Microsoft Defender for Cloud and Azure Monitor to detect and respond to anomalies. Alerts are configured for unusual access patterns and other security events. This also includes alerts for Multi-Logins and suspicious activities.

• Sharing: In the Multiplayer functionality, stereoscopic image displays can be shared between multiple users. The data in transit is encrypted using HTTPS with TLS 1.2.

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Versions and Updates

Users are advised to enable automatic updates (default setting). When automatic updates are enabled, the Windows OS on the HoloLens 2 will automatically check, download, and install updates. The device will install updates when the device is turned off or notify users a reboot is required.

Augmedit B.V. is responsible for all updates to  Lumi Prepare and Lumi Segment, which are automatically deployed in the cloud environment and Microsoft Store once they have been approved, tested, verified, and validated according to the specified regulations and standards. Users will be informed if an update to the Augmented Reality application is required.

The software version number can be found in the "About" section of the 3D viewer, accessible via both the web browser application and the HoloLens 2 application.

Daily backups of configurations and data are created and managed through Azure Backup Vault, with the backup data being immutable to prevent unauthorized changes. Administrators can restore configurations and data using these backups.

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Decommissioning

Secure Decommissioning: Decommissioning of Lumi for an end user involves uninstalling the Lumi application from the Microsoft HoloLens 2:

• Open Start Menu: On your HoloLens, say "Start" or use the Windows button to open the Start Menu.

• Find the App: Locate the app you want to remove in the list of installed apps.

• Select the App: Press and hold the app icon until a context menu appears.

• Uninstall: Select Uninstall from the menu.

• Confirm: Follow the on-screen instructions to confirm the removal of the app.

 

The app will be uninstalled from your HoloLens 2, freeing up storage space and removing its data. This includes any cached encrypted files