Who is the manufacturer of LumiNE US; Lumi?

Augmedit B.V. filed the 510(k) submission for LumiNE US; Lumi (K240094).

What is the FDA product code for LumiNE US; Lumi?

QIH. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for LumiNE US; Lumi?

510(k) clearance (submission type: Traditional).

Does LumiNE US; Lumi use AI or machine learning?

Yes. LumiNE US; Lumi (K240094) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

Who can help prepare an FDA 510(k) submission like LumiNE US; Lumi?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like LumiNE US; Lumi get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

LumiNE US; Lumi

K240094 · Augmedit B.V. · QIH · Sep 10, 2024 · Radiology

Device Facts

Record ID	K240094
Device Name	LumiNE US; Lumi
Applicant	Augmedit B.V.
Product Code	QIH · Radiology
Decision Date	Sep 10, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device

AI Performance

Output	Algorithm	Acceptance	Observed	Dev DS	Dev Readers	Test DS	Test Readers
Intracranial tumor segmentation	nnUnet	Dice > 0.80; 95% HD <= 15 mm	Dice 0.93 (95% CI 0.92-0.94); 95% HD 2.85 mm (95% CI 1.82-4.12 mm)	—	—	Independent U.S. test dataset of MRI-T1 scans	3 (US neurosurgeons)
Brain segmentation	nnUnet	Dice > 0.90; 95% HD <= 10 mm	Dice 0.96 (95% CI 0.95-0.97); 95% HD 5.88 mm (95% CI 4.75-8.39 mm)	—	—	Independent U.S. test dataset of MRI-T1 scans	3 (US neurosurgeons)
Skin segmentation	nnUnet	Dice > 0.90; 95% HD <= 10 mm	Dice 0.99 (95% CI 0.99-0.1); 95% HD 3.36 mm (95% CI 0.99-5.51 mm)	—	—	Independent U.S. test dataset of MRI-T1 scans	3 (US neurosurgeons)
Ventricle segmentation	nnUnet	Dice > 0.85; 95% HD <= 10 mm	Dice 0.89 (95% CI 0.85-0.91); 95% HD 1.93 mm (95% CI 1.70-2.92 mm)	—	—	Independent U.S. test dataset of MRI-T1 scans	3 (US neurosurgeons)

Indications for Use

The LumiNE US software is intended for the visualization of medical images to provide insights in anatomy and pathology in preparation of surgical treatment. As such, the software allows for the conversion of 2D patient imaging into 3D models and for the visualization of 2D and 3D patient imaging including Augmented Reality. When accessing the LumiNE US software from a wireless Head-Mounted Display (HMD) or PC monitor, images viewed are for informational purposes only and not intended for diagnostic use. The LumiNE US software is intended for use by a (neuro)surgical resident or a medical professional that is qualified by a hospital to prepare medical imaging for surgeons. For the conversion of medical imaging into 3D models, Magnetic Resonance Imaging (MRI) and/or Computed Tomography (CT) imaging of adult patients are required. The LumiNE US software is intended to be used for visualization of surgery, and not for diagnostic use. Therefore, segmentation and visualization of tumors or any other pathology can only be used for previously known and pre-diagnosed conditions. LumiNE US can only be used for contrast-enhanced T1 MR scans (sem-automatic segmentation of known tumor, skin, brain, and ventricles), or for CT scans (threshold-based segmentation). The LumiNE US MRI T1 tumor segmentation function can only be used in case of a single intracranial contrast enhancing tumor, diagnosed by a neuroradiologist or a neurosurgeon, with a minimal volume of 2.0 cc (0.1 in3) and a minimal diameter in any direction of 15 mm (0.6 inch), and a maximum volume of 100cc (6.1 in3) and a maximal diameter in any direction of 75 mm (3.0 inch).

Device Story

LumiNE US is a software-based medical image management and processing system for surgical planning. It ingests 2D DICOM imaging (MRI/CT) and transforms it into 3D models via semi-automatic (MRI) or threshold-based (CT) segmentation. The device utilizes non-adaptive machine learning algorithms (nnUnet architecture) for T1-weighted MRI segmentation. Outputs are visualized as 3D models or Augmented Reality (AR) via a wireless Head-Mounted Display (HMD) or PC monitor. Used by neurosurgeons or qualified medical professionals in clinical settings to assist in surgical preparation. The system provides anatomical insights for pre-diagnosed conditions; it does not provide diagnostic outputs. Benefits include enhanced visualization of patient-specific anatomy and pathology, facilitating surgical planning and communication. The device supports remote and co-located sharing of 3D models and annotations.

Clinical Evidence

No clinical trials; performance validated via non-clinical bench testing. Segmentation accuracy (T1cSF) evaluated on an independent U.S. dataset (n=scans meeting inclusion criteria). Primary endpoints: Dice Similarity Coefficient (DSC) and 95% Hausdorff Distance (95% HD). Results: Median DSC for brain (0.96), skin (0.99), tumor (0.93), and ventricles (0.89) exceeded acceptance criteria (0.80–0.90). 95% HD results for all structures were below acceptance thresholds (10–15 mm). Usability confirmed via Moderated Task Analysis (MTA). Visual quality of HMD verified against IEC 63145-20-20/10 standards.

Technological Characteristics

Software-based image processing system. Cloud-based storage and processing; client-side visualization via Microsoft HoloLens 2 or web browser. Segmentation: nnUnet-based machine learning (non-adaptive) for MRI; threshold-based for CT. Connectivity: Wireless encrypted connection. Standards: ISO 13485, ISO 14971, EN 62304. Data formats: DICOM, STL, GLTF, PDF, JPEG, PNG.

Indications for Use

Indicated for adult patients (age 22+) requiring visualization of medical images for surgical planning. Supports contrast-enhanced T1 MRI (semi-automatic segmentation of tumor, skin, brain, ventricles) and CT scans (threshold-based segmentation). Tumor segmentation restricted to single intracranial contrast-enhancing lesions (Glioblastoma, Meningioma, Metastasis) with volume 2.0–100 cc and diameter 15–75 mm. Not for diagnostic use.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

VSI Holomedicine (K213215)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on one line and "ADMINISTRATION" on the line below. The logo is simple and professional, and it is easily recognizable. Augmedit B.V. Claartje Ypma CEO Galerij 15 Naarden, Noord-Holland 1411 LH Netherlands September 10, 2024 Re: K240094 LumiNE US: Lumi Trade/Device Name: Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QIH Dated: January 12, 2024 Received: August 1, 2024 Dear Claartje Ypma: 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/cfpm/pm.cfm identifies combination product submissions. The general controls 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). 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 QS regulation requires device manufacturers to review and approve changes to device design and {1}------------------------------------------------ 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-regulatoryinformation/postmarketing-safety-reporting-combination-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. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advice-comprehensive-regulatory-assistance/unique-deviceidentification-system-udi-system. 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-reporting-mdr-how-report-medicaldevice-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuingeducation/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-devices/deviceadvice-comprehensive-regulatory-assistance/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. Jessica Lamb Jessica Lamb, PhD Assistant Director, Imaging Software Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K240094 Device Name LumiNE US ## Indications for Use (Describe) The LumiNE US software is intended for the visualization of medical images to provide insights in anatomy and pathology in preparation of surgical treatment. As such, the software allows for the conversion of 2D patient imaging into 3D models and for the visualization of 2D and 3D patient imaging including Augmented Reality. When accessing the LumiNE US software from a wireless Head-Mounted Display (HMD) or PC monitor, images viewed are for informational purposes only and not intended for diagnostic use. The LumiNE US software is intended for use by a (neuro)surgical resident or a medical professional that is qualified by a hospital to prepare medical imaging for surgeons. For the conversion of medical imaging into 3D models, Magnetic Resonance Imaging (MRI) and/or Computed Tomography (CT) imaging of adult patients are required. The LumiNE US software is intended to be used for visualization of surgery, and not for diagnostic use. Therefore, segmentation and visualization of tumors or any other pathology can only be used for previously known and pre-diagnosed conditions. LumiNE US can only be used for contrast-enhanced T1 MR scans (sem-automatic segmentation of known tumor, skin, brain, and ventricles), or for CT scans (threshold-based segmentation). The LumiNE US MRI T1 tumor segmentation function can only be used in case of a single intracranial contrast enhancing tumor, diagnosed by a neuroradiologist or a neurosurgeon, with a minimal volume of 2.0 cc (0.1 in3) and a minimal diameter in any direction of 15 mm (0.6 inch), and a maximum volume of 100cc (6.1 in3) and a maximal diameter in any direction of 75 mm (3.0 inch). Type of Use (Select one or both, as applicable) | ☒ Prescription Use (Part 21 CFR 801 Subpart D) | |------------------------------------------------| | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image contains the logo for Augmedit. The logo consists of a stylized graphic above the word "AUGMEDIT" in bold, sans-serif font. The graphic is made up of three overlapping arrow shapes pointing to the right. Image /page/3/Picture/1 description: The image shows the text 'K240094' in a teal color. The text is displayed in a clear, sans-serif font, making it easily readable. The numbers and letters are evenly spaced, contributing to the overall clarity of the image. The background is plain white, which helps the teal text stand out. # 510(k) Summary | Contact Information | | |-------------------------|------------------------------------------------| | Company name: | Augmedit B.V. | | Company owner: | Mrs. Claartje Ypma | | Function: | CEO | | Address: | Galerij 15, 1411 LH Naarden, The Netherlands | | Telephone: | +31 617 1010 94 | | Name of contact person: | Mr. Bryan Bhoelai | | Function: | Regulatory Affairs & Quality Assurance Manager | | Email: | bryan@augmedit.com | | Summary date: | September 10, 2024 | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image contains the logo for Augmedit. The logo consists of a stylized arrow pointing to the right, with three overlapping arrow shapes. Below the arrow is the word "AUGMEDIT" in a bold, sans-serif font. The logo and text are in a dark teal color. # Contents | 1 | | Subject Device Names | | |---|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | വ | | Predicate Device Information | | | ന | Description of the Device | | | | | 4 Indications for Use | | | | ഗ | | Substantial Equivalence Comparison Summary | | | | 5.1 | Substantial equivalence comparison table…………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… | | | | 5.2 | Similarities between the Subject Device and the Predicate Device | | | | | 5.3 Differences between the Subject Device and the Predicate Device | | | | | 6 Summary of Performance Testing | | | 7 | | Validation of Machine Learning Algorithms | | | | | 8 Application of Standards | | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Augmedit. The logo consists of a stylized graphic above the word "AUGMEDIT" in bold, sans-serif font. The graphic is made up of three overlapping arrow shapes, creating a sense of forward movement or progress. #### 1 Subject Device Names Name of device: LumiNE US Trade name: LumiNE US, Lumi #### Predicate Device Information N Trade or proprietary or model name: VSI Holomedicine Original Applicant: ApoQlar GmbH 510(k) Number: K213215 Regulation Number: 21 CFR 892.2050 #### Description of the Device ന LumiNE US is a software device for the visualization of medical images to provide insights in anatomy and pathology in preparation of surgical treatment. As such, the software allows for the conversion of 2D patient imaging into 3D models and for the visualization of 2D and 3D patient imaging including Augmented Reality. When accessing the LumiNE US software from a wireless Head-Mounted Display (HMD) or PC monitor, images viewed are for informational purposes only and not intended for diagnostic use. Applicable pathology includes scans with known intracranial lesions that are diagnosed as Glioblastoma, Meninqioma, or Metastasis by a neurosurgeon or neuroradiologist. #### 4 Indications for Use The LumiNE US software is intended for the visualization of medical images to provide insights in anatomy and pathology in preparation of surgical treatment. As such, the software allows for the conversion of 2D patient imaging into 3D models, and for the visualization of 2D and 3D patient imaging including Augmented Reality. When accessing the LumiNE US software from a wireless Head-Mounted Display (HMD) or PC monitor, images viewed are for informational purposes only and not intended for diaqnostic use. The LumiNE US software is intended for use by a (neuro)surqical resident or a medical professional that is qualified by a hospital to prepare medical imaging for surgeons. For the conversion of medical imaging into 3D models, Magnetic Resonance Imaging (MRI) and/or Computed Tomography (CT) imaging of adult patients are required. The LumiNE US software is intended to be used for visualization in preparation of surqery, and not for diagnostic use. Therefore, seqmentation and visualization of tumors or any other pathology can only be used for previously known and pre-diagnosed conditions. LumiNE US can only be used for contrast-enhanced T1 MR scans (semi-automatic segmentation of known tumor, skin, brain, and ventricles), or for CT scans (threshold-based segmentation). The LumiNE US MRI T1 tumor segmentation function can only be used in case of a single intracranial contrast enhancing tumor, diagnosed by a neuroradiologist or a neurosurgeon, with a minimal volume of 2.0 cc (0.1 in3) and a minimal diameter in any direction of 15 mm (0.6 inch), and a maximum volume of 100cc (6.1 in3) and a maximal diameter in any direction of 75 mm (3.0 inch). #### ഗ Substantial Equivalence Comparison Summary #### 5.1 Substantial equivalence comparison table The following table provides a comparison of the subject device's characteristics and functionality with respect to the identified predicate device. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image contains the logo for Augmedit. The logo consists of a stylized arrow pointing to the right, with three overlapping arrow shapes. Below the arrow is the word "AUGMEDIT" in a bold, sans-serif font. The logo appears to be a dark blue color. | Device characteristics | Subject device | Predicate device | Comparison analysis | |--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device name | LumiNE US | VSI Holomedicine | N/A | | 510(k) number | K240094 | K213215 | N/A | | Manufacturer | Augmedit B.V. | apoQlar GmbH | N/A | | Medical specialty | Radiology | Radiology | Identical | | CFR Reference | 21 CFR 892.2050 | 21 CFR 892.2050 | Identical | | Device classification name | Medical Image management and Processing System | Medical Image management and Processing System | Identical | | Common name | Automated Radiological Image Processing Software | Radiological Image Processing System | Substantially equivalent, the subject device has a more specific common name because of the presence of nonadaptive machine learning algorithms. | | Product code | QIH | LLZ | Substantially equivalent, the subject device has a more specific product code because of the presence of nonadaptive machine learning algorithms. | | Intended use/ Indications for use | The LumiNE US software is intended for the visualization of medical images to provide insights in anatomy and pathology in preparation of surgical treatment. As such, the software allows for the conversion of 2D patient imaging into 3D models, and for the visualization of 2D and 3D patient imaging including Augmented Reality. When accessing the LumiNE US software from a wireless head-mounted display (HMD) or PC monitor, images viewed are for informational purposes only and not intended for diagnostic use. The LumiNE US software is intended for use by a (neuro)surgeon, (neuro)surgical resident or a medical professional that is qualified by a hospital to prepare medical imaging for surgeons. For the conversion of medical imaging into 3D models, Magnetic Resonance Imaging (MRI) and/or Computed Tomography (CT) imaging of adult patients are required. The LumiNE US software is intended to be used for visualization in preparation of surgery, and not for diagnostic use. Therefore, segmentation and visualization of pathology can only be used for previously known and pre- diagnosed conditions. LumiNE US can only be used for contrast-enhanced T1 MR scans (semi-automatic segmentation of known | VSI HoloMedicine® is a software device for displaying digital medical images acquired from CT, Angio CT, MRI, CBCT, PET, and SPECT sources. It is intended to visualize 3D imaging holograms of the patient for pre-operative planning outside and/or inside the surgical room. When accessing VSI HoloMedicine® from a wireless head-mounted display (HMD) or PC monitor, images viewed are for informational purposes only and not intended for diagnostic use. VSI HoloMedicine® is indicated for use by qualified healthcare professionals including surgeons, radiologists, physicians, and technologists. | Substantially equivalent | | Device characteristics | Subject device | Predicate device | Comparison analysis | | | tumor, skin, brain, and ventricles), or for CT scans (threshold-based segmentation). The LumiNE US MRI T1 tumor segmentation function can only be used in case of a single intracranial contrast enhancing tumor, diagnosed by a neuroradiologist or a neurosurgeon, with a minimal volume of 2.0 cc (0.1 in³) and a minimal diameter in any direction of 15 mm (0.6 inch), and a maximum volume of 100cc (6.1 in³) and a maximal diameter in any direction of 75 mm (3.0 inch). | | | | Prescription use | Yes | Yes | Identical | | Patient population | The device specifically focuses on visualization of medical images and preparation of surgical treatment, for patients at the age of 22 or older | The device is a software which allows for viewing of DICOM data. Therefore, its intended use is without any restrictions regarding patient population | Different, but no impact on safety and effectiveness. | | Main system components | Cloud based storage of patient data (including anonymizer) and viewer Microsoft HoloLens 2 Browser based (universal) mobile device viewer | Cloud based storage for patient data Microsoft HoloLens 2 Streaming hardware hub to connect image modalities directly to Microsoft HoloLens 2 Anonymizer (for video's) | Substantially equivalent | | Imaging modality | MRI CT | CT angio CT MRI CBCT PET CT SPECT CT | Substantially equivalent, the subject device uses MRI and CT imaging data, while the predicate device allows to use a broader range of imaging modalities. Thus, the predicate device allows to view more data types in the HoloLens. | | Data Type Supported | DICOM 3D formats: STL GLTF PDF JPEG PNG | DICOM 3D formats: OBJ, STL PDF JPEG PNG MP4 | Substantially equivalent, both the subject device as well as the predicate device support DICOM imaging as well as 3D format types. The predicate device additionally supports data types which allow video streaming. | | | 3D view in web browser | General manipulation in HoloLens (grab, move, | Substantially equivalent: | | Device characteristics | Subject device | Predicate device | Comparison analysis | | Image view/manipulation | Fusion of 3D objects with source image data (web browser and Microsoft HoloLens 2) General manipulation in HoloLens (grab, move, zoom, hide, change color etc.) Surgical preparation tools which allow markings on 3D models in Microsoft HoloLens 2 Sharing (remote and co-located) | zoom, hide, change color etc.) Surgical Preparation Tools (draw, measure, etc). Sharing (remote, but not co-located). | Both the predicate device and Lumi enable marking on 3D models in HMD for planning purposes. Lumi allows for saving revisions on 3D models (both web and Microsoft HoloLens 2) Lumi allows validation of 3D models. | | Communication between headset and computer | Web browser (computer) and Microsoft HoloLens 2 connect to cloud environment. Wireless encrypted connection with Microsoft HoloLens 2. | Web browser (computer) and Microsoft HoloLens 2 connect to cloud environment. Wireless encrypted connection with Microsoft HoloLens 2. Hardware to stream data from image acquisition system directly to Microsoft HoloLens 2. | Substantially equivalent, VSI uses additional hardware to connect to image acquisition systems. Communication for both the subject as well as the predicate device is wireless, and data encrypted. | | MPR viewing | Yes, for CT, MRI | This viewing feature enables the display of CT, MRI, CBCT, Angio CT, PET CT and SPECT CT images into axial, coronal and sagittal orientations | Substantially equivalent for CT and MRI. | | 3D Volume rendered viewing | 3D volume rendering in web browser. Option to create manual segmentation to visualize results in Microsoft HoloLens 2. | 3D perspective views of CT, MRI, CBCT, Angio CT, PET CT and SPECT CT images sets that have been transformed into volumes. It also provides presets to enable users to alter the visualization parameters of the 3D views to highlight features. | Different, but no impact on safety and effectiveness. Both the subject as well as predicate device present 2D imaging information in 3D, however, the predicate device does not include image segmentation functionality. | | Surgical planning | Creating and saving of 3D models and marks thereon on HMD for planning purposes. | Saving and loading configurations of medical images, marks, and 3D models on HMD. Ability to save and load combinations and arrangement of objects displayed in the 3D space on HoloLens for planning purposes. Possibility to create annotation like drawings. | Substantially equivalent | | Transmission modes | Web browser (computer) and Microsoft HoloLens 2 connect | Web browser (computer) and Microsoft HoloLens 2 connect | Substantially equivalent | | Device characteristics | Subject device | Predicate device | Comparison analysis…

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