OrionXR is a software device for display, manipulation, and evaluation of externally-generated 3D models of patient anatomy through an Augmented Reality Head Mounted Display (HMD) to assist in visualization, planning and communication of treatment options.

OrionXR is indicated for use by qualified healthcare professionals including but not restricted to radiologists, nonradiology specialists, physicians, and technologists.

Digital models viewed through the HMD are for informational purposes only and not intended for diagnostic use. OrionXR is not intended to guide surgical instrumentation and it is not to be used for stereotactic procedures or surgical navigation.

OrionXR software is designed for use with performance-tested hardware specified in the User Manual.

Device Description

OrionXR includes a server for uploading pre-acquired 3D annotations of patient anatomy and the Microsoft Hololens 2 head mounted display for visualizing the models via a Mixed reality platform. The components of the device include:

1. Web Server Users can load 3D annotations of anatomy to OrionXR web server which can then be accessed on the Head mounted display.
1. Head Mounted Display OrionXR is compatible with the Microsoft Hololens 2. A user is able to access 3D digital models on the headset. User can manipulate the model in three dimensions of translational and rotational space.

AI/ML Overview

The OrionXR device is a software device intended for display, manipulation, and evaluation of externally-generated 3D models of patient anatomy through an Augmented Reality Head Mounted Display (HMD) to assist in visualization, planning, and communication of treatment options. It is indicated for use by qualified healthcare professionals.

Here's a breakdown of the acceptance criteria and supporting study details:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text doesn't explicitly state quantitative acceptance criteria with pass/fail thresholds for the performance tests. Instead, it describes general design verification and validation activities conducted. The "Reported Device Performance" column reflects the successful execution and meeting of design input requirements.

Acceptance Criteria Category	Reported Device Performance
Dimensional Accuracy of 3D Models	Demonstrated successful performance to ensure output specifications meet design input requirements.
Optical Performance of Headset Display: - Contrast ratio - Resolution - Field of View - Luminance Uniformity - Eyebox - Distortion - Frame Rate	Demonstrated successful performance across these optical parameters to ensure output specifications meet design input requirements. The display frame rate is specified as 60 fps, matching the predicate.
Qualitative Assessment of 3D Anatomic Models	Successfully conducted to ensure output specifications meet design input requirements.
Human Factors and Usability Engineering	Human factors and usability engineering testing was performed. No additional use-related risks to the safety or effectiveness of the device were identified. This included simulated use replicative of both the intended use and the intended environment of use.
Overall Safety and Effectiveness	Performance data demonstrate that the OrionXR is as safe and effective as the predicate device (IntraOpVSP, K213128), and does not raise new issues of safety or effectiveness. The device is capable of accurately uploading and visualizing 3D anatomic models on an HMD.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a distinct "test set" sample size in terms of the number of patient cases or specific instances used for validation, nor does it provide details on data provenance (e.g., country of origin, retrospective/prospective). The performance data section refers to "design verification and validation" generally.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not provide details on the number of experts used or their qualifications for establishing ground truth for any specific test set. The device is a "Medical Image Management And Processing System" that displays externally-generated 3D models for visualization, planning, and communication, rather than performing diagnostic analysis that would typically require expert ground truth labeling.

4. Adjudication Method for the Test Set

No adjudication method is described, as the document does not detail specific expert evaluations of a test set in the manner of diagnostic AI devices.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not explicitly described or performed. The device's indications for use are for visualization, planning, and communication, not for primary diagnostic interpretation or as an AI aid in a traditional diagnostic workflow.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

The performance data described focuses on the device's technical capabilities, such as dimensional accuracy of 3D models and optical performance of the HMD. This can be considered "standalone" in the sense that these are objective measurements of the device's functionality. However, the device itself is an Augmented Reality Head Mounted Display system, inherently designed for human-in-the-loop interaction by qualified healthcare professionals for visualization and planning, not autonomous decision-making. No isolated "algorithm only" performance for diagnostic or analytical tasks is presented, as the device is not intended for such standalone functions.

7. The Type of Ground Truth Used

Given the device's function (display and manipulation of 3D models for visualization and planning), "ground truth" would likely relate to the accuracy of the displayed 3D models against their source data, and the optical performance of the display. The document mentions "Dimensional Accuracy of 3D Models" and "Qualitative Assessment of 3D Anatomic Models" as part of design verification, implying that the accuracy of the digital models and their representation are the primary "ground truths" being assessed against established specifications or source data. It does not mention pathology, outcomes data, or expert consensus in the context of diagnostic "ground truth," as it is not a diagnostic device.

8. The Sample Size for the Training Set

The document does not provide any information regarding a "training set" or its sample size. This is consistent with the device's function as a display and manipulation tool for pre-existing 3D models, rather than a machine learning or AI algorithm that is trained on a dataset. The device receives "externally-generated 3D models," suggesting it doesn't perform internal model generation that would require a dedicated training phase.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned or applicable given the device's nature, the method for establishing ground truth for a training set is not provided.

Summary

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Hoth Intelligence Inc. % Kelliann Payne Partner Hogan Lovells US LLP 1735 Market Street, Suite 2300 PHILADELPHIA, PENNSYLVANIA 19103

September 14, 2023

Re: K232189

Trade/Device Name: OrionXR Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: July 24, 2023 Received: July 24, 2023

Dear Kelliann Payne:

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

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/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-device-advice-comprehensive-regulatoryassistance/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. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K232189

Device Name

OrionXR

Indications for Use (Describe)

OrionXR is indicated for use by qualified healthcare professionals including but not restricted to radiologists, nonradiology specialists, physicians, and technologists.

OrionXR software is designed for use with performance-tested hardware specified in the User Manual.

Type of Use (Select one or both, as applicable)

区 Prescription Use (Part 21 CFR 801 Subpart D)

□ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY Hoth Intelligence, Inc.'s OrionXR K232189

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared:

Hoth Intelligence Inc. 1700 Market Street Unit 1005, Philadelphia, PA 19103

Contact Person: Kelliann Pavne, Hogan Lovells US LLP Phone: (267) 675-4600 Date Prepared: September 14, 2023

Name of Device: OrionXR

Common or Usual Name: Medical image management and processing system

Classification and Product Code: 21 CFR 892.2050; LLZ

Predicate Device: Xironetic, LLC's IntraOpVSP Software Device (K213128)

Intended Use / Indications for Use

OrionXR is a software device for display, manipulation of externally-generated 3D models of patient anatomy through an Augmented Reality Head Mounted Display (HMD) to assist in visualization, planning and communication of treatment options.

OrionXR is indicated for use by qualified healthcare professionals including but not restricted to radiologists, non-radiology specialists, physicians, and technologists.

OrionXR software is designed for use with performance-tested hardware specified in the User Manual.

Technological Characteristics

1. Web Server Users can load 3D annotations of anatomy to OrionXR web server which can then be accessed on the Head mounted display.
1. Head Mounted Display OrionXR is compatible with the Microsoft Hololens 2. A user is able to access 3D digital models on the headset. User can manipulate the model in three dimensions of translational and rotational space.

Performance Data

Software verification and validation were successfully conducted and is summarized below.

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Design verification and validation was performed to ensure that output specifications meet design input requirements:

Dimensional Accuracy of 3D Models ●
Optical Performance of Headset Display: Contrast ratio, Resolution, Field of View, ● Luminance Uniformity, Eyebox, Distortion, Frame Rate
Qualitative Assessment of 3D Anatomic Models.

Human Factors and Usability enqineering testing was also performed to identify use errors that could result in serious harm to the patient or user, as well as to develop relevant risk mitigation measures. This testing included simulated use replicative of both the intended use and the intended environment of use. No additional use-related risks to the safety or effectiveness of the device were identified.

Substantial Equivalence

The OrionXR is as safe and effective as the IntraOpVSP (K213128). The OrionXR has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the OrionXR and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the OrionXR is as safe and effective as IntraOpVSP (K213128). Thus, the OrionXR is substantially equivalent.

	Subject Device	Predicate Device
	OrionXR	IntraOpVSP (K213128)
Indication of Use	OrionXR is a software device fordisplay, manipulation, andevaluation of externally-generated3D models of patient anatomythrough an Augmented RealityHead Mounted Display (HMD) toassist in visualization, planningand communication of treatmentoptions.	IntraOpVSP is a software devicethat is indicated for use with anaugmented reality head-mounteddisplay which allows forvisualization and orientation of3D digital models of selectedstructures of a patient's anatomy.
	OrionXR is indicated for use byqualified healthcare professionalsincluding but not restricted toradiologists, non-radiologyspecialists, physicians, andtechnologists.	IntraOpVSP is intended tosupplement conventional VirtualSurgical Planning (VSP) byfacilitating perception of theshape and scale of a patient'sanatomical targets for use inpreoperative planning and heads-up 3D visualization duringsurgery.
	Digital models viewed through theHMD are for informationalpurposes only and not intendedfor diagnostic use. OrionXR is notintended to guide surgicalinstrumentation and it is not to beused for stereotactic proceduresor surgical navigation.	IntraOpVSP is not intended toprovide diagnosis or to guidesurgical instrumentation. It is notto be used for stereotacticprocedures or surgicalnavigation.
		IntraOpVSP is intended for useby surgeons who have been
	OrionXR software is designed foruse with performance-testedhardware specified in the UserManual.	trained to operate IntraOpVSP.IntraOpVSP software is designedfor use with performance-testedhardware specified in the UserManual.

Intended UseEnvironment	Not for intraoperative use. Thesoftware is intended to be used inthe following environments:• Operating rooms• Office environment withinhospitals or any otherclinical setting• Intensive Care unit,Emergency room, or anyother location wheremedical care is provided	Not for intraoperative use. Foruse in healthcare settings, suchas hospitals, clinics andoperating rooms
Intended users	Qualified healthcare professionalsincluding but not restricted toradiologists, non-radiologyspecialists, physicians, andtechnologists.	IntraOpVSP is intended for useby surgeons who have beentrained to operate IntraOpVSP.
SystemComponents	• Microsoft Hololens 2 Headsetwith near eye see-through display• OrionXR Software application	• Microsoft Hololens 2 Headsetwith near eye see-throughdisplay• Software application
Display FrameRate	60 fps	60 fps
Medical DeviceInterfaces	Pre-operative planningworkstation OrionXR server	Pre-operative planningworkstation Virtual SurgeryPlanning server
CommunicationbetweenHeadset andComputer	Wireless—WiFi communicationwith OrionXR server, encrypted	Wireless, encrypted
HMD PowerSource	Lithium Batteries + 18W charger	Lithium Batteries + 18W charger
Biocompatibility	N/A	N/A
Sterilization	Sterilization not required	Sterilization not required
Data TypeSupported	• STL• OBJ	• STL• OBJ

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Conclusions

OrionXR is substantially equivalent to the predicate device, IntraOpVSP. OrionXR has the same intended use, similar indications for use, technological characteristics and principles of operation as its predicate device. Testing demonstrates that OrionXR is capable of accurately uploading and visualizing 3D anatomic models on a HMD. Thus, OrionXR does not raise different questions of safety and effectiveness and is substantially equivalent to the predicate device.

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).