K Number

Device Name

OpenSight

Manufacturer

Novarad Corporation

Date Cleared

2018-09-21

(407 days)

Product Code

LLZ

Regulation Number

892.2050

Intended Use

OpenSight is intended to enable users to display, manipulate, and evaluate 2D, 3D, and 4D digital images acquired from CR, DX, CT, MR, and PT sources. It is intended to visualize 3D imaging holograms of the patient, for preoperative localization and pre-operative planning of surgical options. OpenSight is designed for use only with performance-tested hardware specified in the user documentation. OpenSight is intended to enable users to segment previously acquired 3D datasets, overlay, and register these 3D segmented datasets with the same anatomy of the patient in order to support pre-operative analysis. OpenSight is not intended for intraoperative use. It is not to be used for stereotactic procedures. OpenSight is intended for use by trained healthcare professionals, including surgeons, radiologists, chiropractors, physicians, cardiologists, technologists, and medical educators. The device assists doctors to better understand anatomy and pathology of patient.

Device Description

OpenSight is the combination of Microsoft HoloLens and Novarad's medical imaging software to create threedimensional holograms of scanned images from different modalities including CR, DX, CT, MR, and PT. This combination of augmented reality glasses and imaging software allows the user to see and manipulate hologram images with the swipe of a finger. OpenSight uses the HoloLens technology to register scanned images over the patient when user has OpenSight headset on and in use. This allows the user to both see the patient and through them, with dynamic holograms of the patient's internal anatomy. OpenSight tools/features include window level, segmentation and rendering, registration, motion correction, virtual tools, alignment, and the capability to measure distance and image intensity values, such as standardized uptake value. OpenSight displays measurement lines, and regions of interest. 3D images include but not limited to tumors, masses, appendices, heart, kidney, bladder, stomach, blood vessels, arteries, and nerves. The OpenSight Augmented Reality system uses the Microsoft HoloLens hardware and the Microsoft 10 Operating System as the platform on which this system runs. The OpenSight technology is written specifically for this hardware. NovaPACS contributes to the process by creating annotations and providing the preoperative analysis of images that are fed to the OpenSight device. The 3D holograms are created by a refractory system in the OpenSight device, using a combination of the Microsoft HoloLens hardware and the OpenSight technology for 3D image display and rendering. Images are actual visible rendered of the object in the OpenSight device. Images are streamed in a 2D format from the Novarad server via wireless communication. The communication is encrypted with 256 encryption. Registration of the patient (reality) to another image data set such as MRI or CT (augmented reality) are performed by the OpenSight device which contains infrared ranging cameras which can map the surface geometry of an object creating a mesh of triangles conforming to whatever the object is. This can include the patient, the surrounding room, the table, etc. The resolution of the mesh is controlled by the device. For mapping a large object such as a room, a larger mesh would be utilized. Surface geometry mapping of a patient's anatomy utilizes the maximum resolution of the device while the user may walk around the object in a 360° circle mapping the object from many views in order to obtain the best localization in space. The camera device from the OpenSight headset has ranging and localizing technology, which maps the surrounding environment, including the patient. It knows where objects are and mesh surface maps of these objects are created for determination of their 3D positioning. The 3D radiologic images are then rendered and surface shells of the patient's skin are matched to the augmented reality device when user has OpenSight headset on and in use. The advantage of this is if the patient moves this can be compensated for. The registration does not require expensive infrared tracking devices or other fiducials in order to perform registration. The anatomy and the correct patient will only register if there is a match of the data, thus diminishing the potentive use on the wrong patient with the wrong images. The patient's anatomy can be displayed in 2D, 3D, or 4D mode. The OpenSight technology allows for virtual screens in space, which are manipulated by finger movement or from voice commands. These images are superimposed on the patient's anatomy and one can either scroll through the images or rotate three dimensionally. Because the holographic system has mapped the space of the room and patient, it "knows" where this is and therefore as one rotates around the patient or the anatomy in question, the images are automatically rotated with the device. The actual visible rendering of the object in the OpenSight device (i.e. how fast can the hologram be updated as ones position relative to the patient changes) has no discernible time lag with the object rendering is in excess of 30 frames per second for standard image rendering). If one turns on advanced lighting and shadowing, cubic spine interpolation of the image and utilizes a large image dataset (in excess of 200 images) then there is a visible time lag between the holographic rendering and the projection on to the patient. See attached video (Motion.MOV) that demonstrates this. It is still less than a second under the worst-case scenario. The rendering tools are derived from technology created in the NovaPACS system for allowing 3D tools, including simple image manipulation such as window/leveling as well as more advanced technologies of segmentation, rendering, registration and motion correction. Virtual tools as well as 3D annotations can be created and displayed in the holographic image. These might include lines, distance measurements, etc. They could also be volumetric measurements or outlines of tumors, anatomic structures, etc. The operating principles of these tools are similar to those with other 3D PACS devices, including technology that has already undergone 510K approval by Novarad Corporation. The OpenSight Augmented Reality system is a device that allows the user to more quickly and more accurately define both anatomy and pathology by using mixed reality. One can see through this device the actual patient but also superimposed on this are holographic images of the patient's anatomy, which have been previously taken through MRI, CT, or other imaging techniques. The following is a description of pre-operative use cases for OpenSight: - . Ability to mark the appropriate entrance point, or angle, trajectory, and location for placement of a needle into the body, to extract a foreign body such as a piece of glass, to place a pedicle screw, etc. Being able to preoperatively identify the anatomy and expected trajectory for device insertion, could greatly aid in facilitating the speed and safety of procedures. Provided are images from three different preoperative interventions; a Percutaneous Discectomy, a Facet injection, and a Sacroiliac Joint. In each case, the OpenSight facilitates the positioning of the best trajectory for entrance into one of these structures. - Ability to aid the operating physician to localize anatomy prior to intervention. This can be used as an aid to . augment, and correlate with the location of a patient's injury. For example, rib fractures can be difficult to localize in the operating room and frequently incisions will be larger than needed in order to plate a displaced rib fracture. Virtually all patients with acute appendicitis in the United States receive a CT scan prior to operative intervention for diagnostic purposes. With this technology, the location of the appendix could be identified and the surgeon would be able to see variations in the anatomy prior to making an incision in an area that may or may not have the appendix. Another example would be the location of masses, lymph nodes, or tumors that may be difficult to find due to body habitus or location. For example, the abilize a disc or vertebral body prior to operative intervention would save valuable surgical time and fluoroscopy. - Ability to superimpose an anatomic atlas upon the patients' anatomy, allowing one to more readily identify structures that would either need to be treated or need to be avoided for a surgical procedure. This could be invaluable for example for a neurosurgeon to understand preoperatively, the best approach for cranial surgery. It could allow a head and neck surgeon to have a better understanding of the skull base in threedimensional detail. This internal visualization can be achieved without the surgeon ever making an incision on the patient. He/she of course can be guided by their best judgment, experience and training as to the ultimate approach and performance of any given procedure. OpenSight is intended simply as a guide. - Ability for surgical trainees to visualize both the internal anatomy from cross sectional imaging such as CT, ● MRI, or PET scanning super imposed on a patient prior to actual operation providing invaluable 3-D understanding of a surgical approach. Such rendering can be performed just prior to the surgery allowing them to see the anatomy and orientation that would be encountered during the surgery. It is much less expensive and complicated than trying to print a 3-D model, which often is not available onsite and can take days to achieve. It also allows the trainee to interrogate in a virtual manner the anatomy of a given area and understand the structural relationships, critical structures that may complicate or interfere with surgery, as well as the unique size/position/orientation of a given patient's anatomy. - Some operations are exceedingly complex and require a much greater depth of understanding in order to ● execute. Such is the case with congenital heart malformations where complex three-dimensional vascular anatomy makes surgical treatment difficult at best. Users are able to visualize this anatomy preoperatively in OpenSight before surgically opening the patient's chest and could potentially speed the operation and allow the surgeons to be better equipped to perform the procedure. Currently these types of procedures are performed after a surgeon has done complex and time consuming 3-D printing of models in order to better understand the anatomy. OpenSight allows one to render this in 2-D, 3-D and 4-D. In this use case, the images do not need to be on the patient. The doctor can rotate and magnify the anatomy free of the patient to get a better visual picture. - As part of the preoperative experience, the target organs can be colored, outlined, or annotated in the medical images using the Novarad 3-D viewer. The annotated-holographic images can be shown to the patient or family superimposed on the patient. This would make the interpretation of the images much clearer. This will improve a patients understanding of the risks and the complexities of a surgical procedure. - Surgeons in general, do not have the same degree of training in imaging and image processing as radiologists and it is often difficult for them to take 2-dimensional anatomy and apply this to their 3-dimensional world. OpenSight will allow Surgeons to better understand complex anatomy and disease processes by taking the data rich information, which they already have, and providing this in a more accessible format through holographic imaging. The value of the OpenSight is that it not only allows one to see the 3-dimensional data sets but also it can be co-localized to the patient and gives the 3-dimensional understanding of what he is attempting to do. Holographic augmented reality allows one to see with better understanding because the images are co-localized to the patient. The system with its mapping cameras, maps both the patient and the surrounding environment; from above, to the side, behind or even underneath the patient. One possible example scenario of using OpenSight for preoperative planning is described in Appendix D. OpenSight is not designed as a primary tool for disease detection or diagnosis. OpenSight integrates with NovaPACS software. OpenSight contains wireless technology using Wi-Fi 802.11ac networking standard. The wreless technology is used to stream images in a 2D format from a Novarad server onto the OpenSight headset. Images are actual visible rendered of the object in the OpenSight device with reliable and accurate information. The wireless information transfer is encrypted with 256 encryption for data security.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K170167, K163622

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes image processing, rendering, registration, and mapping technologies, but does not mention or imply the use of AI or ML algorithms for these functions.

Therapeutic

No
The device is intended for display, manipulation, and evaluation of medical images for pre-operative localization and planning. It is explicitly stated that "OpenSight is not designed as a primary tool for disease detection or diagnosis," and "OpenSight is intended simply as a guide."

Diagnostic

OpenSight explicitly states: "OpenSight is not designed as a primary tool for disease detection or diagnosis." Its intended use is for displaying, manipulating, and evaluating digital images for preoperative localization and planning, assisting in understanding anatomy and pathology, and surgical training, not for making a diagnosis.

SaMD (Software as a Medical Device)

The device description explicitly states that OpenSight is a "combination of Microsoft HoloLens and Novarad's medical imaging software" and "uses the Microsoft HoloLens hardware and the Microsoft 10 Operating System as the platform on which this system runs." It also describes hardware components like infrared ranging cameras for surface geometry mapping. Therefore, it is not a software-only medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, OpenSight is an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use clearly states that OpenSight is intended to "display, manipulate, and evaluate 2D, 3D, and 4D digital images acquired from CR, DX, CT, MR, and PT sources." It is used for "preoperative localization and pre-operative planning of surgical options" and to "support pre-operative analysis." These activities involve the examination of medical images derived from the patient's body to provide information for medical purposes.
Device Description: The device description details how OpenSight processes and displays medical images (scanned images from different modalities) as 3D holograms. It uses software to manipulate and render these images, and provides tools for segmentation, registration, measurement, and annotation of anatomical structures and pathology.
Relationship to IVD Activities: The core function of OpenSight is to process and present medical images for interpretation and analysis by healthcare professionals to aid in pre-operative planning and understanding of a patient's condition. This aligns with the definition of an IVD, which includes devices used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or treatment. While OpenSight doesn't directly analyze a biological specimen in the traditional sense, the medical images it processes are considered "specimens" in the context of diagnostic imaging.
Predicate Devices: The predicate devices listed (K170167 True 3D Viewer Software and K163622 LungVision System) are also medical imaging software/systems, which are typically classified as IVDs or medical devices that perform IVD functions.

While OpenSight is not intended for primary disease detection or diagnosis, its use in evaluating and analyzing medical images for pre-operative planning and understanding anatomy and pathology falls under the scope of IVD activities, as it provides information derived from the patient's body (via imaging) to inform medical decisions.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

OpenSight is intended to enable users to segment previously acquired 3D datasets, overlay, and register these 3D segmented datasets with the same anatomy of the patient in order to support pre-operative analysis.

OpenSight is not intended for intraoperative use. It is not to be used for stereotactic procedures.

OpenSight is intended for use by trained healthcare professionals, including surgeons, radiologists, chiropractors, physicians, cardiologists, technologists, and medical educators. The device assists doctors to better understand anatomy and pathology of patient.

Product codes (comma separated list FDA assigned to the subject device)

LLZ

Device Description

OpenSight uses the HoloLens technology to register scanned images over the patient when user has OpenSight headset on and in use. This allows the user to both see the patient and through them, with dynamic holograms of the patient's internal anatomy. OpenSight tools/features include window level, segmentation and rendering, registration, motion correction, virtual tools, alignment, and the capability to measure distance and image intensity values, such as standardized uptake value. OpenSight displays measurement lines, and regions of interest. 3D images include but not limited to tumors, masses, appendices, heart, kidney, bladder, stomach, blood vessels, arteries, and nerves.

The OpenSight Augmented Reality system uses the Microsoft HoloLens hardware and the Microsoft 10 Operating System as the platform on which this system runs. The OpenSight technology is written specifically for this hardware. NovaPACS contributes to the process by creating annotations and providing the preoperative analysis of images that are fed to the OpenSight device.

The 3D holograms are created by a refractory system in the OpenSight device, using a combination of the Microsoft HoloLens hardware and the OpenSight technology for 3D image display and rendering. Images are actual visible rendered of the object in the OpenSight device. Images are streamed in a 2D format from the Novarad server via wireless communication. The communication is encrypted with 256 encryption.

Registration of the patient (reality) to another image data set such as MRI or CT (augmented reality) are performed by the OpenSight device which contains infrared ranging cameras which can map the surface geometry of an object creating a mesh of triangles conforming to whatever the object is. This can include the patient, the surrounding room, the table, etc. The resolution of the mesh is controlled by the device. For mapping a large object such as a room, a larger mesh would be utilized. Surface geometry mapping of a patient's anatomy utilizes the maximum resolution of the device while the user may walk around the object in a 360° circle mapping the object from many views in order to obtain the best localization in space.

The camera device from the OpenSight headset has ranging and localizing technology, which maps the surrounding environment, including the patient. It knows where objects are and mesh surface maps of these objects are created for determination of their 3D positioning. The 3D radiologic images are then rendered and surface shells of the patient's skin are matched to the augmented reality device when user has OpenSight headset on and in use. The advantage of this is if the patient moves this can be compensated for. The registration does not require expensive infrared tracking devices or other fiducials in order to perform registration. The anatomy and the correct patient will only register if there is a match of the data, thus diminishing the potentive use on the wrong patient with the wrong images.

The patient's anatomy can be displayed in 2D, 3D, or 4D mode. The OpenSight technology allows for virtual screens in space, which are manipulated by finger movement or from voice commands. These images are superimposed on the patient's anatomy and one can either scroll through the images or rotate three dimensionally. Because the holographic system has mapped the space of the room and patient, it "knows" where this is and therefore as one rotates around the patient or the anatomy in question, the images are automatically rotated with the device.

The actual visible rendering of the object in the OpenSight device (i.e. how fast can the hologram be updated as ones position relative to the patient changes) has no discernible time lag with the object rendering is in excess of 30 frames per second for standard image rendering). If one turns on advanced lighting and shadowing, cubic spine interpolation of the image and utilizes a large image dataset (in excess of 200 images) then there is a visible time lag between the holographic rendering and the projection on to the patient. See attached video (Motion.MOV) that demonstrates this. It is still less than a second under the worst-case scenario.

The rendering tools are derived from technology created in the NovaPACS system for allowing 3D tools, including simple image manipulation such as window/leveling as well as more advanced technologies of segmentation, rendering, registration and motion correction. Virtual tools as well as 3D annotations can be created and displayed in the holographic image. These might include lines, distance measurements, etc. They could also be volumetric measurements or outlines of tumors, anatomic structures, etc. The operating principles of these tools are similar to those with other 3D PACS devices, including technology that has already undergone 510K approval by Novarad Corporation.

The OpenSight Augmented Reality system is a device that allows the user to more quickly and more accurately define both anatomy and pathology by using mixed reality. One can see through this device the actual patient but also superimposed on this are holographic images of the patient's anatomy, which have been previously taken through MRI, CT, or other imaging techniques.

The following is a description of pre-operative use cases for OpenSight:

. Ability to mark the appropriate entrance point, or angle, trajectory, and location for placement of a needle into the body, to extract a foreign body such as a piece of glass, to place a pedicle screw, etc. Being able to preoperatively identify the anatomy and expected trajectory for device insertion, could greatly aid in facilitating the speed and safety of procedures. Provided are images from three different preoperative interventions; a Percutaneous Discectomy, a Facet injection, and a Sacroiliac Joint. In each case, the OpenSight facilitates the positioning of the best trajectory for entrance into one of these structures.
Ability to aid the operating physician to localize anatomy prior to intervention. This can be used as an aid to . augment, and correlate with the location of a patient's injury. For example, rib fractures can be difficult to localize in the operating room and frequently incisions will be larger than needed in order to plate a displaced rib fracture. Virtually all patients with acute appendicitis in the United States receive a CT scan prior to operative intervention for diagnostic purposes. With this technology, the location of the appendix could be identified and the surgeon would be able to see variations in the anatomy prior to making an incision in an area that may or may not have the appendix. Another example would be the location of masses, lymph nodes, or tumors that may be difficult to find due to body habitus or location. For example, the abilize a disc or vertebral body prior to operative intervention would save valuable surgical time and fluoroscopy.
Ability to superimpose an anatomic atlas upon the patients' anatomy, allowing one to more readily identify structures that would either need to be treated or need to be avoided for a surgical procedure. This could be invaluable for example for a neurosurgeon to understand preoperatively, the best approach for cranial surgery. It could allow a head and neck surgeon to have a better understanding of the skull base in threedimensional detail. This internal visualization can be achieved without the surgeon ever making an incision on the patient. He/she of course can be guided by their best judgment, experience and training as to the ultimate approach and performance of any given procedure. OpenSight is intended simply as a guide.
Ability for surgical trainees to visualize both the internal anatomy from cross sectional imaging such as CT, ● MRI, or PET scanning super imposed on a patient prior to actual operation providing invaluable 3-D understanding of a surgical approach. Such rendering can be performed just prior to the surgery allowing them to see the anatomy and orientation that would be encountered during the surgery. It is much less expensive and complicated than trying to print a 3-D model, which often is not available onsite and can take days to achieve. It also allows the trainee to interrogate in a virtual manner the anatomy of a given area and understand the structural relationships, critical structures that may complicate or interfere with surgery, as well as the unique size/position/orientation of a given patient's anatomy.
Some operations are exceedingly complex and require a much greater depth of understanding in order to ● execute. Such is the case with congenital heart malformations where complex three-dimensional vascular anatomy makes surgical treatment difficult at best. Users are able to visualize this anatomy preoperatively in OpenSight before surgically opening the patient's chest and could potentially speed the operation and allow the surgeons to be better equipped to perform the procedure. Currently these types of procedures are performed after a surgeon has done complex and time consuming 3-D printing of models in order to better understand the anatomy. OpenSight allows one to render this in 2-D, 3-D and 4-D. In this use case, the images do not need to be on the patient. The doctor can rotate and magnify the anatomy free of the patient to get a better visual picture.
As part of the preoperative experience, the target organs can be colored, outlined, or annotated in the medical images using the Novarad 3-D viewer. The annotated-holographic images can be shown to the patient or family superimposed on the patient. This would make the interpretation of the images much clearer. This will improve a patients understanding of the risks and the complexities of a surgical procedure.
Surgeons in general, do not have the same degree of training in imaging and image processing as radiologists and it is often difficult for them to take 2-dimensional anatomy and apply this to their 3-dimensional world. OpenSight will allow Surgeons to better understand complex anatomy and disease processes by taking the data rich information, which they already have, and providing this in a more accessible format through holographic imaging. The value of the OpenSight is that it not only allows one to see the 3-dimensional data sets but also it can be co-localized to the patient and gives the 3-dimensional understanding of what he is attempting to do. Holographic augmented reality allows one to see with better understanding because the images are co-localized to the patient. The system with its mapping cameras, maps both the patient and the surrounding environment; from above, to the side, behind or even underneath the patient.

OpenSight is not designed as a primary tool for disease detection or diagnosis.

OpenSight integrates with NovaPACS software.

OpenSight contains wireless technology using Wi-Fi 802.11ac networking standard. The wreless technology is used to stream images in a 2D format from a Novarad server onto the OpenSight headset. Images are actual visible rendered of the object in the OpenSight device with reliable and accurate information. The wireless information transfer is encrypted with 256 encryption for data security.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

CR, DX, CT, MR, and PT

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

trained healthcare professionals, including surgeons, radiologists, chiropractors, physicians, cardiologists, technologists, and medical educators.
healthcare settings, such as hospitals and clinics.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance Testing:
Thorough software testing has been performed for OpenSight to the safety and efficacy of the device. Forty-two test cases were run on OpenSight to fulfill the imaging software requirements. All 42 tests passed for case ID 55391.
Venfication and validation activities are performed on OpenSight during software development prior to release, and in an ongoing manner for any updates. OpenSight software passes all performance requirements and meets all specifications prior to release.
OpenSight was also tested to the requirements of ANSI AAMI ES60601-1 and IEC 60601-1-2.

Additional Performance Testing:
Preoperative localization accuracy performance testing was performed. Testing was conducted using Novarad OpenSight software to present the hologram. The overall results from each test provides evidence of acceptable quality and accuracy for pre-operative localization and pre-operative planning.

Sphere Test:
Objective: To determine the accuracy of the projected hologram with the size of the object by comparing the physical circumference with an annotated diameter.
Device Description: Novarad PACS Viewer, OpenSight headset (Microsoft HoloLens), MRI Calibration Sphere.
Test Equipment: EXTECH LT40 LED Light Meter (Asset #13167).
Test Setup: MRI calibration sphere scanned by CT modality. Images processed by Novarad PACS software and viewed through OpenSight headset. Lighting under normal office settings (140 - 250 LUX).
Method: Measured physical circumference of the sphere and compared it to the diameter measured in the virtual image.
Results: Physical circumference = ~1036 mm. Physical diameter =~329.769 mm. Measured virtual diameter = 328.78 mm. Difference = ~.989mm.
Box and BB testing:
Objective: To identify an average offset between the physical object and the hologram displayed from various points of view with a stationary object that has multiple points of references. The degree of offset (distance measured) between the physical object and hologram was measured in 10ths of an inch and converted to mm.
Device Description: Novarad PACS Viewer, OpenSight headset (Microsoft HoloLens), Box (23.6 cm width by 18.8 cm height by 29.6 cm long) with copper BB's.
Test Equipment: EXTECH LT40 LED Light Meter (Asset #13167), H&H CALIPER, DIAL 6' (Asset #13138).
Test Setup: Box with BB's scanned by CT modality. Images processed by Novarad PACS software and viewed through OpenSight headset. Offset measured with an H&H 6' Dial Caliper. Lighting under normal office settings (140 - 250 LUX).
Method: Measured the distance of the offset between the physical BBs and the hologram BBs.
Results: Highest average offset was 1.67 mm, lowest average offset was 0 mm.
Mean offsets:

0 degrees and 6 inches (15.24 cm) away: 0.8596 mm (SD 1.7189 mm)
0 degrees and 1 foot (30.24 cm) away: 0.9861 mm (SD 1.1305 mm)
90 degrees and 6 inches (15.24 cm) away: 1.5213 mm (SD 2.0604 mm)
90 degrees and 1 foot (30.24 cm) away: 0.8050 mm (SD 1.1602 mm)
135 degrees and 6 inches (15.24 cm) away: 2.0825 mm (SD 1.8636 mm)
135 degrees and 1 foot (30.24 cm) away: 1.6913 mm (SD 2.3016 mm)
The angle that has the lowest mean is 90 degrees and one foot away. At 0 degrees and one foot away there is the least amount of deviation in the offset. The 0 degrees and six inches away has a confidence interval that contains zero suggesting that there might not be a significant offset present from that distance and angle. The mean offsets for each angle at one foot tend to be lower than the mean offsets at six inches.

Frame Rates:
The rendering is in excess of 30 frames per second for standard image rendering. With advanced lighting/shadowing, cubic spine interpolation, and large dataset (>200 images), visible time lag (

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
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.(b)
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).

Summary

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 21, 2018

Novarad Corporation Doug Merrill Compliance Manager 752 East 1180 South #200 AMERICAN FORK, UT 84003

Re: K172418

Trade/Device Name: OpenSight Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: LLZ Dated: July 6, 2018 Received: September 11, 2018

Dear Doug Merrill:

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 (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 located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions 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.

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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Hole 2. Mild

for Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known) K172418

Device Name OpenSight

Indications for Use (Describe)

OpenSight is not intended for intraoperative use. It is not to be used for stereotactic procedures.

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)

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510(K) SUMMARY

Submitter

Novarad Corporation

752 East 1180 South, Suite 200

American Fork, UT 84003

E-mail: doug.merrill@novarad.net

Phone: 801-642-1001

Contact Person: Doug Merrill

Date Summary Prepared: 9 September 2018

Device Name

Trade Name: OpenSight

Common Name: Imaging Software

Regulation Name: Picture archiving and communications system

Regulation Number: 21 CFR 892.2050

Product Code: LLZ

Primary Predicate Device

K170167	True 3D Viewer Software	EchoPixel Inc.
---------	-------------------------	----------------

Predicate Device

K163622	LungVision System	Body Vision Medical Ltd.
---------	-------------------	--------------------------

Indication for Use

OpenSight is not intended for intraoperative use. It is not to be used for stereotactic procedures.

Device Description

larger mesh would be utilized. Surface geometry mapping of a patient's anatomy utilizes the maximum resolution of the device while the user may walk around the object in a 360° circle mapping the object from many views in order to obtain the best localization in space.

The following is a description of pre-operative use cases for OpenSight:

. Ability to mark the appropriate entrance point, or angle, trajectory, and location for placement of a needle into the body, to extract a foreign body such as a piece of glass, to place a pedicle screw, etc. Being able to preoperatively identify the anatomy and expected trajectory for device insertion, could greatly aid in facilitating the speed and safety of procedures. Provided are images from three different preoperative interventions; a Percutaneous Discectomy, a Facet injection, and a Sacroiliac Joint. In each case, the OpenSight facilitates the positioning of the best trajectory for entrance into one of these structures.

Ability to aid the operating physician to localize anatomy prior to intervention. This can be used as an aid to . augment, and correlate with the location of a patient's injury. For example, rib fractures can be difficult to localize in the operating room and frequently incisions will be larger than needed in order to plate a displaced rib fracture. Virtually all patients with acute appendicitis in the United States receive a CT scan prior to operative intervention for diagnostic purposes. With this technology, the location of the appendix could be identified and the surgeon would be able to see variations in the anatomy prior to making an incision in an area that may or may not have the appendix. Another example would be the location of masses, lymph nodes, or tumors that may be difficult to find due to body habitus or location. For example, the abilize a disc or vertebral body prior to operative intervention would save valuable surgical time and fluoroscopy.
Ability to superimpose an anatomic atlas upon the patients' anatomy, allowing one to more readily identify structures that would either need to be treated or need to be avoided for a surgical procedure. This could be invaluable for example for a neurosurgeon to understand preoperatively, the best approach for cranial surgery. It could allow a head and neck surgeon to have a better understanding of the skull base in threedimensional detail. This internal visualization can be achieved without the surgeon ever making an incision on the patient. He/she of course can be guided by their best judgment, experience and training as to the ultimate approach and performance of any given procedure. OpenSight is intended simply as a guide.
Ability for surgical trainees to visualize both the internal anatomy from cross sectional imaging such as CT, ● MRI, or PET scanning super imposed on a patient prior to actual operation providing invaluable 3-D understanding of a surgical approach. Such rendering can be performed just prior to the surgery allowing them to see the anatomy and orientation that would be encountered during the surgery. It is much less expensive and complicated than trying to print a 3-D model, which often is not available onsite and can take days to achieve. It also allows the trainee to interrogate in a virtual manner the anatomy of a given area and understand the structural relationships, critical structures that may complicate or interfere with surgery, as well as the unique size/position/orientation of a given patient's anatomy.
Some operations are exceedingly complex and require a much greater depth of understanding in order to ● execute. Such is the case with congenital heart malformations where complex three-dimensional vascular anatomy makes surgical treatment difficult at best. Users are able to visualize this anatomy preoperatively in OpenSight before surgically opening the patient's chest and could potentially speed the operation and allow the surgeons to be better equipped to perform the procedure. Currently these types of procedures are performed after a surgeon has done complex and time consuming 3-D printing of models in order to better understand the anatomy. OpenSight allows one to render this in 2-D, 3-D and 4-D. In this use case, the images do not need to be on the patient. The doctor can rotate and magnify the anatomy free of the patient to get a better visual picture.
As part of the preoperative experience, the target organs can be colored, outlined, or annotated in the medical images using the Novarad 3-D viewer. The annotated-holographic images can be shown to the patient or family superimposed on the patient. This would make the interpretation of the images much clearer. This will improve a patients understanding of the risks and the complexities of a surgical procedure.
Surgeons in general, do not have the same degree of training in imaging and image processing as radiologists and it is often difficult for them to take 2-dimensional anatomy and apply this to their 3-dimensional world. OpenSight will allow Surgeons to better understand complex anatomy and disease processes by taking the data rich information, which they already have, and providing this in a more accessible format through

Novarad OpenSight 510(k) Submission | 2018

holographic imaging. The value of the OpenSight is that it not only allows one to see the 3-dimensional data sets but also it can be co-localized to the patient and gives the 3-dimensional understanding of what he is attempting to do. Holographic augmented reality allows one to see with better understanding because the images are co-localized to the patient. The system with its mapping cameras, maps both the patient and the surrounding environment; from above, to the side, behind or even underneath the patient.

One possible example scenario of using OpenSight for preoperative planning is described in Appendix D.

OpenSight is not designed as a primary tool for disease detection or diagnosis.

OpenSight integrates with NovaPACS software.

Substantial Equivalence

Research and testing data provide evidence that OpenSight is substantially equivalent to the represented predicate devices: True 3D Viewer Software, a class II device under 21 CFR 892.2050; and LungVision, a class II device under 21 CFR 892.2050.

OpenSight and predicate devices are Radiological Image Processing Systems, which retrieve, store, and display images from DICOM compliant medical imaging modalities and/or systems. They are intended to be used in healthcare settings, such as hospitals and clinics, on 3d party off-the-shelf hardware. They are intended to provide qualified medical professionals with a variety of tools and software features for the viewing, and annotation of medical images.

Performance testing results show that the software features of OpenSight operate correctly and safely, meet equivalent objectives, and perform equivalent functions as those represented in the predicate device. Performance testing also shows that the unique combination of safety features represented in OpenSight does not raise any additional safety concerns.

Performance Testing

Thorough software testing has been performed for OpenSight to the safety and efficacy of the device. Forty-two test cases were run on OpenSight to fulfill the imaging software requirements. All 42 tests passed for case ID 55391. We believe that the testing performed so far is sufficient to conclude that the features and functionality of OpenSight software is substantially equivalent to the predicate devices, and that it does not raise any new safety concerns.

Venfication and validation activities are performed on OpenSight during software development prior to release, and in an ongoing manner for any updates. OpenSight software passes all performance requirements and meets all specifications prior to release, including:

All requirements in the iteration have a test case and the test case has run and passed a.
b. All Acceptance tests have passed

C. All Current tests have passed
All high-impact bugs have been corrected and verified by Quality Assurance d.
Any unresolved anomalies have been assessed in a risk meeting, and it has been found that they do e. not pose any safety risks to the end user (or their patients) and do not substantially affect the performance of OpenSight software.

Performance testing data has been included in an Appendix A to this submission.

OpenSight was also tested to the requirements of ANSI AAMI ES60601-1 and IEC 60601-1-2.

Additional Performance Testing

Preoperative localization accuracy performance testing was performed in accordance with the description and requirements described in the following testing environments. Testing was conducted using Novarad OpenSight software to present the hologram. The overall results from each test provides evidence of acceptable quality and accuracy for pre-operative localization and pre-operative planning.

1) Sphere Test

Introduction:

Object used in this test was, obtained from Riverwood's imaging: Object: Sphere used in MRI calibrations. Computerized tomography (CT) was used to scan the object. OpenSight headset is used to display the augmented reality (AR) on the object. The purpose of this test is to determine the physical circumference with an annotated diameter to determine the accuracy of the projected hologram with the size of the object.

Device Description:

Novarad PACS Viewer: Novarad PACS Viewer software. -
-OpenSight headset (Microsoft HoloLens)
MRI Calibration Sphere: -

Test Equipment:

Asset #	Manufacturer	Model #	Serial #	Model Description	Calibration Cert #
13167	EXTECH	LT40	171200265	LED Light Meter	652644

Test setup:

MRI calibration sphere was scanned by CT modality. Images were then processed and virtualized by Novarad PACS software and viewed though the OpenSight headset lighting for this test was under normal office settings of 140 - 250 LUX.

Method:

The following calculations were used to determine an accurate measurement between the hologram and the object. Measurement of the physical circumference of the sphere to find the difference between the physical diameter, and the diameter measured in the virtual image.

Results:

Measurement of the sphere was as follows: physical circumference = ~1036 mm. diameter of the sphere was determined by using diameter = circumference\n with the result physical diameter =~329.769 mm. Measured virtual diameter= 328.78 mm. Subtracted the calculated physical diameter with the virtual diameter showing a difference of ~.989mm between the physical measured diameter and virtual generated image and annotated diameter.

Figures:

Image /page/9/Picture/3 description: The image shows a CT scan of a small ball. The scan was taken on November 6, 2017, at 12:37 PM. The ball has a diameter of 328.78 mm. The CT scan shows the internal structure of the ball.

Figure 1:

Measurements of image in the PACS Software. A circle measurment and diameter measurment was made in the PACS software. Views shown (top left) axial, (top right) coronal, (bottom left) sagittal, (bottom right) 3D.

Novarad OpenSight 510(k) Submission | 2018

Image /page/10/Picture/0 description: The image shows a blue balloon being measured with a yellow measuring tape. The tape is wrapped around the balloon's circumference, with a hand holding the tape in place. The numbers on the tape are visible, ranging from 97 to 107, and also 67 to 69.

Image /page/10/Figure/1 description: The image contains the text "Figure 2:". The text is written in a simple, sans-serif font. The text is black and the background is white.

Measurement of the physical object with the use of a sewing measuring tape. Showing the cercumfronce at 1036 mm.

Image /page/10/Picture/3 description: The image shows a spherical lamp that is glowing with a warm, orange light. The lamp appears to be sitting on a flat surface, and there is a faint pattern visible on its surface, possibly due to the internal structure or design. The background is slightly blurred, suggesting a shallow depth of field, and there is a hint of other objects or furniture in the periphery.

Figure 3: 3D view of the hologram overlay presented over the top the MRI Sphere.

Image /page/11/Picture/0 description: The image shows a light blue sphere with a bright orange glow around the edges. A horizontal line of the same orange glow cuts through the middle of the sphere. The sphere is in front of a window with a white frame. The image is labeled "A."

Image /page/11/Figure/2 description: The image contains a large, bold letter "B" in black. The letter is sans-serif and takes up most of the frame. The background is plain white, providing a stark contrast to the black letter.

Figure 4: A) Circular and diameter measurement of the sphere at the same angle, which the measurement was taken (axial view) (measurement of annotion can not be seen). B) Screen shot was taken of the annotion at an angle to show the measurement of the diamter (annotated measurment is 328.78 mm).

Note images taken of the hologram through the OpenSight headset:

The OpenSight headset generates a 3D picture using both lenses. Pictures taken with a camera from one side of the OpenSight headset or the other, there is a slight discrepancy on the opposite side of the hologram from the field of view the picture was taken from. ~1.7 % offset noticeable when looking through one lens. When viewing through both lenses the offset is equalized.

Figure 5.1 -5.3: Test was done under normal office settings of 140 - 250 LUX with the OpenSight headset ~ 1.5 Meters from the object.

Image /page/12/Figure/0 description: The image contains three diagrams and two photographs. The diagrams show a camera and hololens setup with fields of view projected onto a sphere with a red outline hologram. Figure 5.1 shows the left hololens field of view, while the right is not looking into the hololens field of view. Figure 5.2 shows the right hololens field of view, while the left is not looking into the hololens field of view.

Image /page/12/Figure/1 description: The image shows the text "Figure 5.3". The text is in a simple, sans-serif font and is positioned at the top of the image. The background is plain and white, providing a clear contrast for the text.

2) Box and BB testing

Introduction:

Object used in this test was, obtained from Riverwood's imaging: Object: Box with set BB's. Computerized tomography (CT) was, used to scan the object. OpenSight headset is used to display the augmented reality (AR) to view the hologram on the object. The purpose of this test was to identify an average offset between the physical object and the hologram displayed from various points of view with a stationary object that has multiple points of

references. The degree of offset (distance measured) between the physical object and hologram was measured in 10th of an inch and converted to mm.

Device Description:

-Novarad PACS Viewer: Novarad PACS Viewer software.
-OpenSight headset (Microsoft HoloLens)
Box (23.6 cm width by 18.8 cm height by 29.6 cm long) with copper BB's -

Test Equipment:

Asset #	Manufacturer	Model #	Serial #	Model Description	Calibration Cert #
13167	EXTECH	LT40	171200265	LED Light Meter	652644
13138	H&H	N/A	N/A	CALIPER, DIAL 6'	648376

Test setuo:

The OpenSight headset was running the Novarad OpenSight software to present the hologram. The object created in this test was a box with bb's glued to the outside. The box with BB's used as an object to test the accuracy of the hologram and measuring the spatial difference between physical bb and hologram bb. "O" indicates that the hologram bb and physical bb are in the same place. "1 +", Hologram bb and physical bb are offset in number amounts, indicated numbers reflected for millimeter (mm). Distances were measured in .001 of an inch and converted to mm. The individual using the OpenSight headset mantained Lighting for this test was under normal office settings of 140 - 250 LUX

Method:

Box and copper bb's were scanned by CT modality. Images were then processed and virtualized by Novarad PACS software and viewed though the OpenSight headset. The offset was measured with an H&H 6' Dial Caliper. It was used to determine an accurate measurement between the hologram and the object. Measurement of the distance, offset from one side of the point of interest (bb) to the same side of the corresponding hologram.

Distance of the offset: The distance between an object and the hologram generated by augmented reality. Depending user's point of view and the point of interest there can be a small offset of what the user can perceive as accurate or not. See the following diagram/figures as an example:

Results:

Perspective of four individuals of the same object and images were measured showing at any measured point (bb) had an off set of, highest average 1.67 mm and a lowest average offset of 0 mm. (offset of hologram from real object):

When the viewer was facing north and viewing the box, we decided that it would be a 0 degree angle from the center of the box, west was 90 degrees and south west was 135 degrees.

The mean offset from each direction, north, west and southwest, without accounting for distance are, respectively, 0.9415 mm (standard deviation 1.4092 mm) , 1.1631 mm (standard deviation 1.6932 mm), and 1.8869 mm (standard deviation 2.0811 mm). If we are accounting for distance away from the box, north, west and southwest at 6 inches away, the mean offsets were, respectively, 0.8596 (standard deviation 1.7189 mm), 1.5213 (standard deviation 2.0604 mm), and 2.0825 (standard deviation 1.8636 mm). Those were farther away on average than the mean offsets from a distance of 1 foot (except for the north direction), which were, respectively, 0.9861

mm (standard deviation 1.1305 mm), 0.8050 mm (standard deviation 1.1602 mm), and 1.6913 mm (standard deviation 2.3016 mm).

The angle that has the lowest mean is the 90 degrees and one foot away. At 0 degrees and one foot away there is the least amount of deviation in the offset. The 0 degrees and six inches away has a confidence interval that contains zero suggesting that there might not be a significant offset present from that distance and angle. The mean offsets for each angle at one foot tend to be lower than the mean offsets at six inches.

Means (SDs):

0 degrees and 6 inches (15.24 cm) away: 0.8596 (1.7189 mm) 0 degrees and 1 foot (30.24 cm) away : 0.9861 mm (1.1305 mm) 90 degrees and 6 inches (15.24 cm) away: 1.5213 (2.0604 mm) 90 degrees and 1 foot (30.24 cm) away: 0.8050 mm (1.1602 mm) 135 degrees and 6 inches (15.24 cm) away: 2.0825 (1.8636 mm) 135 degrees and 1 foot (30.24 cm) away: 1.6913 mm (2.3016 mm) Confidence Intervals:

0 degrees and 6 inches (15.24 cm) away: (-0.0459 mm, 1.7650 mm)

0 degrees and 1 foot (30.24 cm) away : (1.3628 mm, 1.9731 mm)

90 degrees and 6 inches (15.24 cm) away: (0.7065 mm, 2.3360 mm)

90 degrees and 1 foot (30.24 cm) away: ( 0.1573 mm, 1.4527 mm)

135 degrees and 6 inches (15.24 cm) away: ( 1.5678 mm, 2.5972 mm)

135 degrees and 1 foot (30.24 cm) away: ( 0.8246 mm, 2.5609 mm)

Image /page/14/Figure/11 description: The image shows a cube with black dots on its surface, representing physical BBs. Some of the dots have red circles around them, indicating the hologram of the BBs. A diagram in the upper left corner illustrates how to measure the distance between the physical BB and its hologram. A legend on the right side of the image identifies the symbols used.

Figure 6:

Representation of how the offset was measured when vieweing the model box and bb's though the Novarad Opensite software. Example of how the user's point of view is effected by each reference point in a likeness diagram.

Image /page/15/Picture/2 description: The image shows a table with a Windows Mixed Reality Headset Developer Edition box on it. A hand is holding a measuring tool up to the box. There are yellow labels with numbers on them attached to the table around the box. The numbers on the labels are 2, 4, 5, and 6.

Figure 7:

Example of how measurement of offset was determined (bright white = hologram, Silver = physical bb).

Image /page/16/Picture/0 description: The image shows a box with a green border. The box has the words "Windows Mix Reality Headset Developer Edition" printed on it. There are also numbers 1-6 on the box.

Image /page/16/Figure/1 description: The image shows the text "Figure 8:". The text is in a simple, sans-serif font and is left-aligned. The text is black against a white background.

Second example of how measurement of offset was determined (bright white = hologram, Silver = physical bb).

Image /page/16/Picture/3 description: The image shows a close-up of a dial caliper. The caliper has a circular dial with numbers ranging from 0 to 100. The text on the caliper reads "HHIP", "SHOCKPROOF", and "STAINLESS HARDENED". The caliper appears to be made of metal.

Figure 9: H&H 6" Dial Caliper

Overall Totals (mm):

| | Lowest
Point /AVG Min | Highest
Max | AVG Max for
each point | AVG for each
point median |
|---|--------------------------|----------------|---------------------------|------------------------------|
| 1 | 0 | 4.45 | 3.06 | 0.57 |
| 2 | 0 | 5.08 | 3.38 | 0.57 |
| 3 | 0 | 4.37 | 3.56 | 1.01 |
| 4 | 0 | 6.86 | 5.09 | 1.34 |
| 5 | 0 | 5.69 | 3.06 | 0.47 |
| 6 | 0 | 4.57 | 3.61 | 1.18 |

7	3.2	3.2	1.45
8	4.22	4.22	1.67
9	3.45	3.45	0.86
10	3.84	3.84	0.96
11	0	0	0

Front facing 6 inches:

Point	Max	Median
1	1.14	0.29
2	5.08	1.47
3	3.3	0.83
4	6.1	1.53
5	1.42	0.36
6	2.8	0.7

Image /page/17/Figure/3 description: The image shows a box with the words "Windows Mixed Reality Headset Developer Edition" printed on it. There are six yellow numbered stickers on the box, numbered 1 through 6. The stickers are connected by lines, forming a geometric pattern on the box. The box appears to be made of cardboard and has a blue and white color scheme.

Front facing 1 foot:

Point	Max	Median
1	2.26	0.57
2	3.02	0.57
3	4.05	1.01
4	5.35	1.34
5	1.88	0.47
6	2.84	1.18
7	3.2	1.45
8	4.22	1.67
9	3.45	0.86
10	3.84	0.96
11	0	0

Image /page/17/Picture/6 description: The image shows a blue and white box with the words "Windows Mix Reality Headset Developer Edition" printed on the top. There are yellow labels with numbers 1-6 on the top of the box. The box is sitting on a white surface.

Side facing 6 inches:

Point	Max	Median
1	3.56	1.46
2	2.29	0.57
3	4.37	1.09
4	6.86	1.72
5	3.81	2.19
6	3.3	2.1

Image /page/18/Figure/2 description: The image shows a box for an HP Windows Mixed Reality Headset Developer Edition. The box is light gray with blue accents and has the HP logo on the top. There are yellow sticky notes with numbers on them placed around the box, connected by lines. The box also features the Windows logo and an image of a VR headset.

Side facing 1 foot:

Point	Max	Median
1	2.54	0.96
2	1.88	0.47
3	2.54	0.96
4	2.49	0.62
5	1.17	0.29
6	3.56	1.52

Image /page/18/Picture/5 description: The image shows a box for the HP Windows Mixed Reality Headset Developer Edition. The box is light gray on the top and blue on the bottom. The HP logo and the words "Windows Mixed Reality Headset Developer Edition" are printed on both the top and bottom of the box. There are also several yellow sticky notes attached to the box.

Diagnol facing 6 inches:

Point	Max	Median
1	4.45	2.06
2	3.18	2.33
3	3.81	0.95
4	4.38	2.66
5	4.38	1.91
6	4.57	2.57

Image /page/18/Picture/8 description: The image shows a box for the "Windows Mixed Reality Headset Developer Edition" by HP. The box is light gray on top and blue on the sides. There are yellow square stickers with numbers on them placed on the box, connected by lines.

Diagnol facing 1 foot:

Point	Max	Median
1	4.42	2.06
2	4.83	1.97
3	3.3	0.83
4	5.33	1.33
5	5.69	2.82
6	4.57	1.14

Image /page/19/Picture/2 description: The image shows a box for a Windows Mixed Reality Headset Developer Edition. The box is light blue and white, with the HP logo on the side. The box has yellow sticky notes on the corners and edges. There are also small silver balls attached to the sticky notes, connected by thin lines.

3) Frame Rates:

The actual visible rendering of the object in the OpenSight device (i.e. how fast can the hologram be updated as ones position relative to the patient changes) has no discernible time lag with the object rendering (i.e. the rendering is in excess of 30 frames per second for standard image rendering). If one turns on advanced lighting and shadowing, cubic spine interpolation of the image and utilizes a large image dataset (in excess of 200 images) then there is a visible time lag between the holographic rendering and the projection on to the patient. See attached video (Motion.MOV) that demonstrates this. It is still less than a second under the worst-case scenario.

Images are displayed at 60 fps. Normal mode is 30 fps.

In Volume mode the geometry is recomputing at 6 fps.

Image /page/19/Picture/7 description: The image shows a person wearing a headset with a brain scan overlayed on top of their head. The brain scan is a 3D rendering of a human brain, and it is positioned so that it appears to be inside the person's head. The image also shows a whiteboard with some writing on it, and a computer monitor. The text at the bottom of the image says "Frame Rate: 6 fps".

In Alignment mode the geometry is recomputing at 13-15 fps.

Image /page/20/Picture/1 description: The image shows a person sitting at a desk in an office setting. A large, translucent orange dome is superimposed over the person's head, possibly indicating a virtual reality or augmented reality application. The text "Frame Rate: 14 fps" is visible, suggesting a performance metric of the application. The background includes a whiteboard with diagrams, a computer monitor, and office cubicles.

In Slice mode the geometry is recomputing at 40-50 fps.

Image /page/21/Picture/0 description: The image shows a brain scan being displayed on a screen. The scan is in color and shows the different parts of the brain. The text "Frame Rate: 43 fps" is visible at the bottom of the screen. The brain scan is surrounded by a white border.

4) Surface Geometry Mapping:

Surface mesh images:

Image /page/22/Picture/0 description: The image shows a CPR training mannequin on a white table. The mannequin is lying on its back, and its head is turned to the left. The mannequin is made of a light-colored plastic, and it has a green overlay on its face and chest. The table is in a room with white walls and a gray floor.

Image /page/22/Picture/1 description: The image shows a medical mannequin lying on a white table. The mannequin is light brown and has green markings on its chest and face. A QR code is taped to the side of the mannequin. There are also some office supplies on the table, including a pencil and a ruler.

Image /page/22/Picture/2 description: The image shows a mannequin of a human torso on a white table. The mannequin is light brown and has a hole in the lower back. There is a green overlay on the mannequin, covering the neck, chest, and lower back. A ruler and pencil are on the table in the background.

Other office settings such as Operating Room and other room settings brightness did not affect the field of view projected inside the device. See attached jpeg files showing the performance of the device measured at 3743, 407.8, & 157.9 LUX. The ambient levels seen in the different room settings where the device is intended to be used did not influence the object appearing in the line of sight.

The overall results provides evidence of acceptable image quality, visualization, and accuracy for pre-operative localization and pre-operative planning.