SurgicalAR is a software device for display of medical images and other healthcare data. It includes functions for image review image manipulation, basic measurements and 3D visualizations and 3D volume rendering).

Lossy compressed mammography images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA cleared display that meets technical specifications reviewed and accepted by FDA or displays accepted by the appropriate regulatory agency for the country in which it is used.

Display monitors used for reading medical images for diagnostic purposes must comply with the applicable regulatory approvals and quality control requirements for their use and maintenance.

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

When accessing SurgicalAR software from a wireless stereoscopic head-mounted display (HMD) or mobile device, images viewed are for informational purposes only and not intended for diagnostic use.

Device Description

SurgicalAR is a software platform to be used by clinicians for the visualization of medical images in 3D to allow for surgical planning activities. The device takes pre-acquired 2D medical images and reconstructs 3D models that a clinician can then view on a stereoscopic, holographic display.

The software application is used to:

• Load patient CT/MR DICOM data

• View DICOM data using a traditional computer monitor or in Augmented Reality (AR) using a head-mounted display, HMD.

AI/ML Overview

The provided document K190764 for the device SurgicalAR is a 510(k) premarket notification and details the device's substantial equivalence to a predicate device. It does not contain information about acceptance criteria and a study proving the device meets those criteria, as typically found in clinical validation studies.

The document primarily focuses on demonstrating that SurgicalAR has the same intended use and similar technological characteristics to its predicate device (VitreaView K163232). It highlights differences in features that do not introduce new safety or effectiveness concerns.

Therefore, I cannot extract the requested information (acceptance criteria, device performance, sample sizes, expert qualifications, ground truth, MRMC study, etc.) from the provided text, as this type of information is generally part of a separate clinical validation study report, not a 510(k) summary demonstrating substantial equivalence.

The "Tests conducted" Section 5.9 mentions "design verification" and "design validation, including human factors and usability engineering." However, it only provides high-level statements about their success ("met the design input requirements," "met all predetermined acceptance criteria") without detailing specific performance metrics or the methodology of the validation studies in a way that would address your questions.

Summary

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May 13, 2019

Image /page/0/Picture/1 description: The image shows 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.

MEDIVIS, Inc. % Ms. Amy Lynn Regulatory Affairs Consultant 20 Jay Street, Suite 312 BROOKLYN NY 11201

Re: K190764

Trade/Device Name: SurgicalAR Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: March 15, 2019 Received: March 25, 2019

Dear Ms. Lynn:

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/cfpmp/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

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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 medical devices and radiation-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,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and 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) K190764

Device Name SurgicalAR

Indications for Use (Describe)

Display monitors used for reading medical images for diagnostic purposes must comply with the applicable regulatory approvals and quality control requirements for their use and maintenance.

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

When accessing SurgicalAR software from a wireless stereoscopic head-mounted display (HMD) or mobile device, images viewed are for informational purposes only and not intended for diagnostic use.

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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Section 5 - 510(k) Summary

Company:	MEDIVIS, Inc.
Address:	20 Jay Street, Suite 312Brooklyn, New York, 11201
Contact:	Amy Lynn
	Regulatory Affairs Consultant
Telephone Number:	954.600.8299
Email:	amylynncicatello@gmail.com
Preparation Date:	March 15, 2019
Trade Name:	SurgicalAR
Device Common Name:	System, Image Processing, Radiological
Classification Regulation:	21 CFR 892.2050
Classification Name:	Picture archiving and communications system
Class:	II
Panel:	Radiology
Product Code:	LLZ
Predicate Device:	VitreaView (K163232)

5.1 Device Description

The software application is used to:

• Load patient CT/MR DICOM data

• View DICOM data using a traditional computer monitor or in Augmented Reality (AR) using a head-mounted display, HMD.

5.2 Intended Use

K190764

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Display monitors used for reading medical images for diagnostic purposes must comply with the applicable regulatory approvals and quality control requirements for their use and maintenance.

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

When accessing SurgicalAR software from a wireless stereoscopic head-mounted display (HMD) or mobile device, images viewed are for informational purposes only and not intended for diagnostic use.

5.3 Operator profile

Qualified healthcare professionals, including but not restricted to surgeons, radiologists, nonradiology specialists, physicians, and technologists.

5.4 Patient population

The device is software which allows for viewing of DICOM data. Therefore, there is no specific patient population.

5.5 Intended use environment The software is intended to be used:

In operating rooms
In office environments within hospitals or at any other location with a computer
. For informational only purposes at any location using the head-mounted display (HMD)

5.6 Operating principle

There are different operating principles such as viewing:

On desktop PCs with a traditional monitor the interaction with the software is performed with a mouse and/or keyboard;
On PCs with a touchscreen monitor the interaction with the software is performed with a touchscreen interface; or
On a head-mounted display the interaction with the software is performed using hand ● gestures.

5.7 Part of the body or type of tissue applied or interacted with

The device is software only which allows for the viewing of DICOM data. Therefore, it does not interact with any body and/or tissue part and the viewing is also not limited to any body and/or tissue part.

5.8 Comparison to predicate device

The SurgicalAR proposed device is substantially equivalent to the predicate device. K163232. as both devices have the same intended use and technological characteristics. While both devices do not have the exact same software features, the difference does not pose any safety and/or effectiveness questions. A full substantial equivalent discussion is provided in Section 12. The exact feature differences and omissions are detailed in the tables contained within Section 12.

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The proposed device slightly differs from the predicate device in two ways as listed below:

First, the proposed device is not available for use through internet browsers like the predicate device. The predicate device allows access via an internet browser in addition to traditional installation on a PC's hard drive. This design difference does not create new or additional safety risks regarding the use of the device but rather limits the scope of accessibility of SurgicalAR.

Secondly, the proposed device does not contain all of the same features as the predicate device. The lack of features are not key features nor do they impact the function or intended use of the device.

The table below demonstrates the similarities in technology and features between SurgicalAR and the predicate device.

Criteria	Description	Subject Device	Predicate Device	Comparison
Annotation andMeasurement Tools	• Line• Angle• Ruler• Arrow	Yes	Yes	Same
User InstallationRequirements	• Runs within browserusing HTML andJavaScript only• No installation isrequired on user's machine	No	Yes	Different.Predicate allowsfor access via Internet.
Data TypeSupported	• DICOM• Non-DICOM	Yes	Yes	Same
ImageView/Manipulation	• Image Zoom• Pan• Window Level• AutoWindow• Level• Reset• Scout Lines• Image Rotate• Image Flip• Magnify• Image Invert• Image Cine	No	Yes	Different.Predicate has"image invert"and "image cine" features.
Data Encryption	• HTTPS• SSL	Yes	Yes	Same
	Description	Subject Device	PredicateDevice	Comparison
Criteria	SurgicalAR	Vitrea View(K163232)
PatientDemographicDisplay	Capable of displayingpatient demographicinformation	Yes	Yes	Same
Linking	Co-planar linking:• Autolink• Manual	Yes	Yes	Same
User and PasswordControl	Users can be managedvia an internaldatabase, activedirectory, or parentapplication	Yes	Yes	Same
Data Security	Stored on server	Yes	Yes	Same
Audit Trail	Audit trail logged	Yes	Yes	Same
User Management	Database structureallows mapping usersto groups internally ormapping externalgroups (AD, parentapplication) to internalgroups and role
TransmissionModes	Via the web withInternet browsers	No	Yes	Different.Predicate allowsfor access viaInternet.
File Type Used	• JPEG forLossydata• PNG forLossless data	Yes	Yes	Same
MPR Viewing	This viewing featureenables the display ofreformatted CT andMR images into axial,coronal and sagittalorientations	Yes	Yes	Same
3D VolumeRendered Viewing	This viewing featureenables the display of3D perspective viewsof CT and MR imagesets that have beentransformed into	Yes	Yes	Same
Criteria	Description	Subject Device	Predicate Device	Comparison
	volumes. It alsoprovides presets toenable users to alterthe visualizationparametersof the 3D views tohighlight features.	SurgicalAR	Vitrea View(K163232)
Active Target Tool	This viewing featureprovides a facility toview a single targetlocation withinmultiple images.	Yes	Yes	Same
CrosshairNavigation andSynchronization	This viewing featureprovides a facility tosynchronize and scrollthrough multipleviews at the sametime.	Yes	Yes	Same
Ability to cloneimages side by side	Ability to cloneimages side by side.	No	Yes	Different.Predicatecontains a"clone"copy/pastefeature.
Ability to close animage by clickingan "X" in theupper-left portionof the view port	Ability to close animage by clicking an"X" in the upper-leftportion of theviewport.	Yes	Yes	Same
Ability to selectlocale and languagesettings on thelogin screen	Ability to select localeand language settingson the login screen.	No	Yes	Different.Predicate hassupport formultiplelanguages.
Ability tocustomize thecolumns in thestudy directory byselecting thedropdown arrow on	Ability to customizethe columns in thestudy directory byselecting thedropdown arrow onthe right side of eachcolumn.	No	Yes	Different.Predicate hasfeature tocustomize theview of thedirectory.
Criteria	Description	Subject Device	PredicateDevice	Comparison
the right side ofeach column.
Help Tips	Proactive help tipsappear for 10-15seconds to educateusers on certainfunctionality that maynot be obvious to anew user.	No	Yes	Different.Predicate hasfeature to view"help tips".
Support for TIFFiles	Vitrea View candisplay TIF files.	Yes	Yes	Same
Tabletsupport forinformationpurposeonly(Not for diagnosticuse)	This viewing featureprovides access ofVitrea View softwareon various iOS andAndroid tabletdevices through thedefault internetbrowser. Keyfeatures are:• Two-fingerpinch tozoom andpan• Touch anddrag toscroll• Double-tap toaccessGesturemenu• TapCarouselthumbnail,then tapImage Paneto swapimages• AmbientLightingCheck	No	Yes	Different.Predicate hassupport for iOSand Android fornon-diagnosticviewing.
HMD support forinformation	This viewing featureprovides access ofSurgicalAR software	No	Yes	Different.Proposed devicehas support for
Criteria	Description	Subject Device	Predicate Device	Comparison
purpose only (notfor diagnostic use)	on consumer, off-the-shelf-wireless, Wi-Fienabled, stereoscopichead-mounted displaywith minimum of 2GBRAM	SurgicalAR	Vitrea View(K163232)	HMDs for non-diagnosticviewing.
Diagnosticquality medicalimage review	Ability to providediagnostic qualitymedical image reviewfor multi-dimensionaldigital imagesacquired from avariety of imagingdevices	Yes	Yes	Same

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5.9 Tests conducted

Both design verification and design validation were successfully conducted as part of the testing for the SurgicalAR device.

The purpose of the design verification activity was to ensure that the design output specifications met the design input requirements. Deviations associated with the written protocol were captured within the design verification report. These deviations did not negatively impact the device, it's intended use, nor did they introduce additional risks. Therefore, it is concluded at the design verification was successful in that the design output specifications satisfactorily met the design input requirements.

Design validation, including human factors and usability engineering, was conducted. Human factors and usability engineering testing was performed to assess user interactions with the device's user interface. The purpose is to identify use errors that would or could result in serious harm to the patient or user. Human factors validation testing is also used to assess the effectiveness of risk management measures. The testing performed was simulated use. The design validation was successfully completed, and testing met all predetermined acceptance criteria. Furthermore, no additional risks to the safety or efficacy of the device were identified.

5.10 Essential performance characteristics

SurgicalAR is software for medical image visualization. A hardware shutdown, power failure or other hardware issue that makes the software inoperable does not cause harm. Therefore, no unacceptable risk arises if the hardware loses performance. The hardware does not have any essential performance characteristics. The software risks were analyzed to find risks in the intolerable range. No risks have been identified in the intolerable range. As such, no measures are considered essential performance characteristics. In summary, the SurgicalAR software does not have any essential performance characteristics.

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).