IntraOp VSP is a software device that is indicated for use with an augmented display which allows for visualization and orientation of 3D digital models of selected structures of a patient's anatomy.

IntraOpVSP is intended to supplement conventional Virtual Surgical Planning (VSP) by facilitating perception of the shape and scale of a patient's anatomical targets for use in preoperative planning and heads-up 3D visualization during surgery.

IntraOpVSP is not intended to provide diagnosis or to guide surgical instrumentation. It is not to be used for stereotactic procedures or surgical navigation.

IntraOpVSP is intended for use by surgeons who have been trained to operate IntraOpVSP software is designed for use with performance-tested hardware specified in the User Manual.

Device Description

IntraOpVSP software displays 3D objects as holograms to inform the user on operative planning. It includes functions for 3D object spatial manipulation and orientation. IntraOpVSP software provides additional information to the surgeon by displaying holograms of the surgical plan, anatomical structures, and guides.

AI/ML Overview

The provided text from the 510(k) summary for the IntraOpVSP software device does not contain a detailed study proving the device meets specific acceptance criteria with reported device performance metrics in a tabular format. The summary states that "design validation was successfully completed, and testing met all predetermined acceptance criteria." However, it does not enumerate these criteria or provide quantitative results from performance testing related to the device's specific functions (e.g., accuracy of 3D object spatial manipulation, accuracy of orientation, or the effectiveness of facilitating perception of shape and scale).

Instead, the summary focuses on:

Substantial equivalence to a predicate device (OpenSight K172418) based on intended use and technological characteristics.
Mentioning adherence to various standards and guidance documents for performance testing, human factors, hazard analysis, and software verification/validation.
A general conclusion that testing demonstrates the device is "at least as safe and effective as the predicate device."

Therefore, based solely on the provided text, the following information cannot be fully extracted or is not explicitly detailed:

A table of acceptance criteria and the reported device performance: Not provided. The document states "testing met all predetermined acceptance criteria" but does not list the criteria or the specific performance results.
Sample size used for the test set and the data provenance: Not provided. The document mentions "simulated use, and actual use in simulated surgery" but does not specify the number of cases or the origin of the data used for validation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
Adjudication method for the test set: Not provided.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not explicitly stated. The validation mentions "validation of trained users' operation of the device in a simulated surgical environment," but it does not describe a comparative effectiveness study with and without AI assistance or report an effect size for human reader improvement.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not explicitly detailed. The device is described as "software that is indicated for use with an augmented display" and "intended to supplement conventional Virtual Surgical Planning," implying human interaction is integral to its intended use and evaluation.
The type of ground truth used: Not explicitly stated. For a device intended for visualization and planning, ground truth might involve measurements compared to anatomical models or clinical outcomes, but this is not specified.
The sample size for the training set: Not applicable/provided. The document does not describe a machine learning model that would require a distinct training set. The descriptions focus on software functions and visualization of pre-segmented 3D models.
How the ground truth for the training set was established: Not applicable/provided.

Summary of what can be extracted or inferred regarding the study based on the provided text:

Study Type: Design verification and design validation, including simulated use and actual use in simulated surgery. Validation with intended users was performed.
Performance Metrics Mentioned (for augmented reality display): Gamma response, contrast and contrast ratio, resolution, luminance and luminance variation, virtual field of view, display obstructions, and distortion. However, the acceptance criteria for these and the reported device performance against those criteria are not provided.
Ground Truth (inferred for display performance): Testing was done to IEC 63145-20-10: 2019 and IEC 63145-20-20: 2019. This suggests objective measurements against these standards would serve as the ground truth for display characteristics.
Human Factors/Usability Testing: Performed following "Guidance for Industry and Food and Drug Administration Staff, February 3, 2011" and IEC 62366-1:2015. This indicates an evaluation of user interface and interaction but doesn't specify performance metrics for the device's functional output.
Software Verification and Validation: Performed according to IEC 62304: 2015 and FDA's guidance on Software as Medical Device (SAMD). This confirms adherence to software development lifecycle standards.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for 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 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.

Xironetic, LLC % Elaine Duncan President Paladin Medical, Inc PO Box 560 STILLWATER MN 55082

Re: K213128

October 21, 2022

Trade/Device Name: IntraOpVSP Software Device Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: September 15, 2022 Received: September 21, 2022

Dear Elaine Duncan:

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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR

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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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-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/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. Ph.D. 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) K213128

Device Name IntraOpVSP software device

Indications for Use (Describe)

IntraOp VSP is a software device that is indicated for use with an augmented display which allows for visualization and orientation of 3D digital models of selected structures of a patient's anatomy.

IntraOpVSP is not intended to provide diagnosis or to guide surgical instrumentation. It is not to be used for stereotactic procedures or surgical navigation.

IntraOpVSP is intended for use by surgeons who have been trained to operate IntraOpVSP software is designed for use with performance-tested hardware specified in the User Manual.

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

X 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:	Submitted on behalf of:
Company Name:Address:	Xironetic, LLC712 N. Broadway, Ave.Oklahoma City, OK 73102, USA
Telephone:	605-412-3574
by:	Elaine Duncan, M.S.M.E., RACPresident, Paladin Medical, Inc.PO Box 560Stillwater, MN 55082
Telephone:	715-549-6035
Fax:	715-549-5380
CONTACT PERSON:	Elaine Duncan
DATE PREPARED:	September 15, 2022
TRADE NAME:	IntraOpVSP software device
COMMON NAME:	Imaging Software;
CLASSIFICATION #:	Class II
CLASSIFICATION NAME:	System, Image Processing, Radiological
REGULATION & PRO CODE:	21 CFR 892.2050; LLZ

DEVICE DESCRIPTION:

INDICATIONS FOR USE:

IntraOpVSP is a software device that is indicated for use with an augmented reality head-mounted display which allows for visualization and orientation of 3D digital models of selected structures of a patient's anatomy. IntraOpVSP software is intended to supplement conventional Virtual Surgical Planning (VSP) by facilitating perception of the shape and scale of a patient's anatomical targets for use in preoperative planning and heads-up 3D visualization during surgery.

IntraOpVSP is not intended to provide diagnosis or to guide surgical instrumentation. It is not to be used for stereotactic procedures or surgical navigation. IntraOpVSP is intended for use by surgeons who have been trained to operate IntraOpVSP. IntraOpVSP software is designed for use with performance-tested hardware specified in the User Manual.

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SUBSTANTIAL EQUIVALENCE:

The proposed software device, IntraOpVSP, is substantially equivalent to the predicate device, OpenSight (K172418). The intended use of both the proposed device and predicate device is for visualizing 3D patient data using augmented reality for planning purposes; therefore, the devices have the same intended use or general purpose. The two devices have equivalent technological characteristics, with slight differences in software features as described below:

IntraOpVSP software utilizes 3D models that are pre-segmented, typically from CT or MRI data, generated by Virtual Surgical Planning software. OpenSight is intended to enable users to segment previously acquired 3D datasets.

IntraOpVSP's software features are designed for preoperative planning purposes and to evaluate surgical options during surgery. OpenSight's software features are designed for preoperative localization and preoperative planning of surgical options. Neither device is intended for intraoperative use or stereotactic procedures.

When used according to its labeling, IntraOpVSP software raises no questions of safety and effectiveness relative to the predicate device. The table below demonstrates in technological characteristics and software features between IntraOpVSP and the predicate device, OpenSight. Differences are indicated in the table, but the characteristics or features with differences are deemed equivalent if no questions of safety or effectiveness are raised when the proposed device is used according to its labeling.

ltem	Subject Device:IntraOpVSP	Predicate Device:OpenSight (K172418)	Comments
Indications for Use	IntraOpVSP is a software device thatis indicated for use with anaugmented reality head-mounteddisplay which allows for visualizationand orientation of 3D digital models ofselected structures of a patient'sanatomy.IntraOpVSP is intended tosupplement conventional VirtualSurgical Planning (VSP) by facilitatingperception of the shape and scale ofa patient's anatomical targets for usein preoperative planning and heads-up 3D visualization during surgery.IntraOpVSP is not intended to providediagnosis or to guide surgicalinstrumentation. It is not to be usedfor stereotactic procedures or surgicalnavigation.	OpenSight is intended to enable users todisplay, manipulate, and evaluate 2D,3D, and 4D digital images acquired fromCR, DX, CT, MR, and PT sources.It is intended to visualize 3D imagingholograms of the patient, on the patient,for pre- operative localization andpreoperative planning of surgical options.OpenSight is designed for use only withperformance-tested hardware specifiedin the user documentation.OpenSight is intended to enable users tosegment previously acquired 3Ddatasets, overlay, and register these3Dsegmented datasets with the sameanatomy of the patient in order to supportpreoperative analysis.	Equivalent - IntraOpVSPfocuses on 3D data from CT,MR and PT sources.
Item	Subject Device:IntraOpVSP	Predicate Device:OpenSight (K172418)	Comments
	IntraOpVSP is intended for use bysurgeons who have been trained tooperate IntraOpVSP. IntraOpVSPsoftware is designed for use withperformance-tested hardwarespecified in the User Manual.	OpenSight is not intended forintraoperative use. It is not to be used forstereotactic procedures.OpenSight is intended for use by trainedhealthcare professionals,including surgeons, radiologists,chiropractors, physicians, cardiologists,technologists, and medical educators.The device assists doctors to betterunderstand anatomy and pathology ofpatient.
Intended UseEnvironment	Not for intraoperative use. For use inhealthcare settings, such ashospitals, clinics and operating rooms	Not for intraoperative use. For use inhealthcare settings, such as hospitalsand clinics	Equivalent - IntraOpVSP isalso to be used for planningpurposes during surgery.
SystemComponents	Headset with near eye see-through display and tracking camera Software application Optical tracking technology	Headset with near eye see-through display and tracking camera Software application Optical tracking technology	Equivalent.
Modes ofOperation	System Set-up Preoperative scan Preoperative planning and planning during surgery VSP Data Import 3D Data Orientation	System Set-up Preoperative scan Preoperative planning Scan Import Patient Registration	Equivalent.
LocalizationTechnology	Mesh surface maps	Mesh surface maps	Equivalent.
User Interface	Voice commands Hand gestures Multiple heads-up menu displays	Voice commands Hand gestures Multiple heads-up menu displays	Equivalent.
VisualizationPlatform	Augmented reality using near-eyesee-through display; data displayedon patient's anatomy for preoperativeuse and as heads-up display during asurgical procedure	Augmented reality using near-eye see-through display; data displayed onpatient's anatomy	Equivalent.
Display FrameRate	60 fps	60 fps	Equivalent.
Medical DeviceInterfaces	Pre-operative planning workstationVirtual Surgery Planning server	Pre-operative planning workstationNovarad PACS server	Equivalent - Virtual SurgeryPlanning server provides 3Ddata to IntraOpVSP insteadof Novarad PACS server.
Item	Subject Device:IntraOpVSP	Predicate Device:OpenSight (K172418)	Comments
Communicationbetween headsetandcomputer/server	Wireless, encrypted	Wireless, encrypted	Equivalent.

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K213128

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K213128

SUMMARY of TESTING:

Both design verification and design validation were successfully conducted as part of the testing for the IntraOpVSP software device. Design verification was successful in that the design output specifications satisfactorily met the design input requirements. Similarly, design vas successfully completed, and testing met all predetermined acceptance criteria. The testing performed was simulated use, and actual use in simulated surgery. No additional risks to the safety or effectiveness of the device were identified from testing. The following standards and guidance documents were referenced in conducting this testing:

Performance of the augmented reality display was determined suitable for the intended use by characterizing its gamma response, contrast and contrast ratio, resolution, luminance and luminance variation, virtual field of view, display obstructions, and distortion, with testing to IEC 63145-20-10: 2019 and IEC 63145-20-20: 2019 as applicable.
Validation with intended users: validation of training protocol and validation of trained users' operation of the device in a simulated surgical environment, followed "Guidance for Industry and Food and Drug Administration Staff, February 3, 201" and IEC 62366-1:2015 for Human Factors and Usability testing.
Hazard analysis was performed following ISO 14971: 2019, and all hazards identified had mitigations implemented and validated through testing, where applicable, to determine acceptable residual risk.
Software verification and validation was performed according to IEC 62304: 2015: Medical Device Software - Software Lifecycle processes and FDA's guidance on Software as Medical Device (SAMD): Clinical Evaluation - Guidance for Industry and Food and Drug Administration Staff, December 8, 2017.

SAFETY AND EFFECTIVENESS CONCLUSION:

Testing demonstrates that IntraOpVSP is at least as safe and effective as the predicate device. Use of IntraOpVSP during surgery provides additional benefits for surgical planning with equivalent safety when used according to its labeling. Based on the documentation submitted in this premarket application, including performance testing and device labeling, along with the benefit-risk analysis, IntraOpVSP is concluded to be 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).