SOTA Cloud Imaging is indicated for use as a clinical software application that receives images and data from Clio or Clio Prime sensors and various imaging sources (e.g., radiographic devices, digital video capture devices, and generic image devices such as scanners). In addition, SOTA Cloud Imaging enables the storage of clinical notes and clinical exam data.

SOTA Cloud Imaging is intended to acquire, display, process, edit (e.g., resize, adjust contrast, annotate, etc.), review, store, print, and distribute images using standard PC hardware. SOTA Cloud Imaging is also intended for use for diagnostic and non-diagnostic purposes in the field of Dentistry by dental professionals who are responsible for providing dental care.

Device Description

SOTA Cloud Imaging is a cloud-based dental imaging software that allows access to diagnostic images on any PC with an active internet connection. SOTA Cloud Imaging's single page application design makes the inbrowser imaging experience fast, familiar, and simple to operate. SOTA Cloud Imaging is feature rich, including full feature parity with traditional client-server based dental imaging software. With SOTA Cloud Imaging, you can use digital dental imaging devices in a manner consistent with your existing imaging solutions, and bridge patient information either from your existing client-server-based practice management software or modern cloud-based practice management software.

SOTA Cloud Imaging is a Class II dental imaging software that includes the ability to acquire, view, annotate, and organize dental radiographs and color images. SOTA Cloud Imaging integrates with most major client-server and web-based practice management software. Images stored using SOTA Cloud Imaging are saved using lossless compression, and can be exported as DICOM, PNG, JPEG, or PDF files.

SOTA Cloud Imaging is a software-only dental image device which allows the user to acquire images using standard dental imaging devices, such as intraoral X-ray sensors and intraoral cameras.

SOTA Cloud Imaging is imaging software designed for use in dentistry. The main SOTA Cloud Imaging software functionality includes image acquisition, organization, and annotation. SOTA Cloud Imaging is used by dental professional for the visualization of patient images retrieved from a dental imaging device or scanner, for assisting in case diagnosis, review, and treatment planning. Doctors, dental clinicians, and other qualified individuals can display and review images, apply annotations, and manipulate images.

SOTA Cloud Imaging is a standalone product but is designed to work cooperatively with dental practice management software that is used for scheduling, clinical note taking, and billing,

The software operates upon standard PC hardware and displays images on the PC's connected display/monitor.

SOTA Cloud Imaging neither contacts the patient nor controls any life sustaining devices. Diagnosis is not performed by this software but by doctors and other qualified individuals. A physician, providing ample opportunity for competent human intervention, interprets images and information being displayed and printed.

AI/ML Overview

The provided text describes the 510(k) premarket notification for "SOTA Cloud Imaging," a dental imaging software. The document asserts the device's substantial equivalence to a predicate device, "XV Web." However, it does not contain details about acceptance criteria, a specific study design to prove device performance against those criteria, or quantitative results from such a study.

The document states:

"SOTA Imaging has conducted extensive non-clinical (bench) performance testing and validation and verification testing of SOTA Cloud Imaging. All the different components of the SOTA Cloud Imaging have been stress tested to ensure that the SOTA Cloud Imaging provides all the capabilities necessary to operate in a manner substantially equivalent to the XV Web predicate." (Section I)
"SOTA Imaging has performed performance testing to compare SOTA Cloud Imaging to the XV Web predicate. Based on the performance testing of the XV Web predicate and SOTA Cloud Imaging, SOTA Cloud Imaging is substantially equivalent in performance specification to the XV Web predicate. Test information can be located within the Software Documentation included with this submission." (Section J)
"Additionally, the results of the performance testing, which included positive and negative testing against the device requirements, predicate testing and human factors testing, has demonstrated that SOTA Cloud Imaging is safe and effective for its intended use and that SOTA Cloud Imaging is substantially equivalent to the currently marketed XV Web predicate." (Section J)

These statements indicate that testing was performed, but they do not provide the specific details requested in your prompt. The document focuses on demonstrating substantial equivalence based on similar intended use and technical characteristics to a predicate device, rather than proving performance against quantitative acceptance criteria in a clinical study. This is typical for a 510(k) submission for this class of device, which often relies on bench testing and comparison to predicates rather than large-scale clinical trials.

Therefore, I cannot populate the table or answer most of your detailed questions based solely on the provided text. The document refers to "Test information" being in "Software Documentation included with this submission," which is not part of this extract.

Here's a summary based on what is available:

Absence of Detailed Performance Study Information

The provided 510(k) summary for "SOTA Cloud Imaging" asserts substantial equivalence to a predicate device, "XV Web," based on intended use, indications for use, and technological characteristics. While it mentions "extensive non-clinical (bench) performance testing and validation and verification," and "performance testing to compare SOTA Cloud Imaging to the XV Web predicate," it does not include specific acceptance criteria, quantitative performance metrics, or the details of any human reader study or standalone algorithm performance study. The focus is on functionality comparison rather than a formal clinical performance study with defined endpoints and ground truth.

1. Table of acceptance criteria and reported device performance

Acceptance Criteria	Reported Device Performance
NOT PROVIDED	NOT PROVIDED
(The document states "extensive non-clinical (bench) performance testing and validation and verification testing" and "performance testing to compare SOTA Cloud Imaging to the XV Web predicate," but does not detail acceptance criteria or specific quantitative results.)

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified in the provided text.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The testing appears to be non-clinical/bench testing and "predicate testing" rather than a clinical study on patient data from a specific geography.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not specified. The document does not describe a clinical ground truth establishment process for a test set. This device is described as imaging software where "Diagnosis is not performed by this software but by doctors and other qualified individuals. A physician, providing ample opportunity for competent human intervention, interprets images and information being displayed and printed." This implies human interpretation remains central.

4. Adjudication method for the test set

Not applicable/Not specified.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study is described or implied. The software is a "Medical Image Management and Processing System" that displays and allows manipulation of images, not an AI-assisted diagnostic tool that would typically undergo such a study.

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

Not applicable. The device is a "software-only dental image device" intended to be used by "dental professionals" for "diagnostic and non-diagnostic purposes." Its function is to acquire, display, process, and manage images, not to provide standalone diagnostic output. Thus, a standalone performance evaluation in the context of diagnostic accuracy is not relevant to its stated function.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable/Not specified. The document does not describe a process for establishing ground truth for diagnostic accuracy, as the device itself does not perform diagnosis.

8. The sample size for the training set

Not applicable/Not specified. The document does not describe an AI/ML model for which a training set would be required. The software appears to be rule-based or feature-based image processing and management, not an AI/ML diagnostic algorithm.

9. How the ground truth for the training set was established

Not applicable/Not specified (as no AI/ML training set is mentioned).

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized design. To the right is the FDA logo, with the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in a larger, bolder font, and "ADMINISTRATION" in a smaller font below.

Sota Precision Optics, Inc. dba SOTA Imaging % Mr. W. Edward Johansen Official Correspondent 1073 North Batavia Street, Suite B ORANGE CA 90404

Re: K210682

Trade/Device Name: SOTA Cloud Imaging Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: March 9, 2021 Received: March 10, 2021

Dear Mr. Johansen:

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

May 4, 2021

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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,

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) K210682

Device Name

SOTA Cloud Imaging

Indications for Use (Describe)

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

K210682

Dated: April 30, 2021

A. Submitter's Name: Sota Precision Optics, Inc. dba SOTA Imaging

Address: 1073 North Batavia Street, Suite B, Orange, California 92867

Telephone: (714) 532-6100

Official Correspondent: W. Edward Johansen,

Telephone: (310) 795-7425

E-mail address: wedjohansen@msn.com

Address: 1239 Stanford Street, #205, Santa Monica, California 90404

B. Identification of New Device

Owner/Operator/Manufacturer: SOTA Imaging

Establishment Registration Number: 3000190675

510(k) Premarket Notification Number: K210682

Trade Name: SOTA Cloud Imaging

Common Name: Dental imaging software

Classification Name: Medical Image Management and Processing System

Product Code: LLZ

Classification: Class II

Panel: Radiology

Class: II

Panel: Radiology

Regulation Number: 21 C.F.R. §892.2050

C. Identification of Predicate Device

Owner/Operator/Manufacturer: Apertyx, Inc.

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510(k) Premarket Notification Number: K132342

Trade Name: XV Web

Common Name: Dental imaging software

Classification Name: Medical Image Management and Processing System

Product Code: LLZ

Classification: Class II

Panel: Radiology

Requlation: Number: 21 C.F.R. §892.2050

D. Device Description

SOTA Cloud Imaging is a software-only dental image device which allows the user to acquire images using standard dental imaging devices, such as intraoral X-ray sensors and intraoral cameras.

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dental professional for the visualization of patient images retrieved from a dental imaging device or scanner, for assisting in case diagnosis, review, and treatment planning. Doctors, dental clinicians, and other qualified individuals can display and review images, apply annotations, and manipulate images.

SOTA Cloud Imaging is a standalone product but is designed to work cooperatively with dental practice management software that is used for scheduling, clinical note taking, and billing,

The software operates upon standard PC hardware and displays images on the PC's connected display/monitor.

E. Intended Use

SOTA Cloud Imaging software is designed for use by dental practices for tracing and presenting patient images which are utilized by dental professionals to assist in treatment planning and case diagnosis. Results produced by the software's diagnostic and treatment planning tools are dependent on the interpretation of trained and licensed dental practitioners.

SOTA Cloud Imaging is indicated for use as a clinical software application that receives images and data from Clio or Clio Prime x-ray sensors and various other imaging sources (e.g., radiographic devices, digital video capture devices, and generic image devices such as scanners). In addition, SOTA Cloud Imaging enables the storage of clinical notes and clinical exam data.

It is intended to acquire, display, process, edit (e.g., resize, adjust contrast, annotate, etc.), review, store, print, and distribute images using standard PC hardware.

SOTA Cloud Imaging interacts with imaging devices connected to a Windows PC. SOTA Cloud Imaging controls the direct capture of digital xray images from Clio and Clio Prime intraoral x-ray sensors and other FDA

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approved radiographic imaging devices, views and captures live image from intraoral cameras via USB 2.0 or video capture card, imports images from various sources such as radiographic devices, flatbed scanners, digital cameras, and generic image devices, exports, e-mail, prints images, processes digital images with several tools to enhance their diagnostic value, and creates a database of patients and store images in patient folders on cloud server storage.

F. Indications for Use

G. Technical Characteristics

SOTA Cloud Imaging is a software only device that is operated by users via a modern web-browser. On the server side, SOTA Cloud Imaging is written in C# and runs in a stateless containerized environment. SOTA Cloud Imaging uses Microsoft Azure SQL databases and Microsoft Azure Blob storage to store application metadata and images. On the client-side, SOTA Cloud Imaging executes in a modern web-browser using HTML5, CSS3, and JavaScript.

H. Off-the-Shelf Software

SOTA Imaging has conducted an appropriate hazard analysis and basic documentation of all off-the-shelf software prior to its utilization in the SOTA Cloud Imaging product, in accordance with the OTS Software Decision Schematic in the FDA guidance document entitled "Off-The-Shelf Software Use in medical Devices" issued on September 27th, 2019. All included offthe-shelf software is used strictly in non-diagnostic capacity and is not directly interacted with by the user. The off-the-shelf software used in this product is documented in the Software Information section of this filing.

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I. Summary of Non-Clinical (bench) Performance Testing

SOTA Imaging has conducted extensive non-clinical (bench) performance testing and validation and verification testing of SOTA Cloud Imaging. All the different components of the SOTA Cloud Imaging have been stress tested to ensure that the SOTA Cloud Imaging provides all the capabilities necessary to operate in a manner substantially equivalent to the XV Web predicate.

J. Summary of Clinical Performance Testing

SOTA Imaging has performed performance testing to compare SOTA Cloud Imaging to the XV Web predicate. Based on the performance testing of the XV Web predicate and SOTA Cloud Imaging, SOTA Cloud Imaging is substantially equivalent in performance specification to the XV Web predicate. Test information can be located within the Software Documentation included with this submission.

Additionally, the results of the performance testing, which included positive and negative testing against the device requirements, predicate testing and human factors testing, has demonstrated that SOTA Cloud Imaging is safe and effective for its intended use and that SOTA Cloud Imaging is substantially equivalent to the currently marketed XV Web predicate.

K. Non-Applicable Requirements

SOTA Cloud Imaging is a software product. Therefore, the requirement of Sterilization does not apply.

SOTA Cloud Imaging is a software product. Therefore, the requirement of specifying Shelf Life does not apply.

SOTA Cloud Imaging does not contain patient contacting elements. Therefore, the requirement for Biocompatibility does not apply.

SOTA Cloud Imaging is a software product which does not have electronic components. Therefore, the requirement of Electromagnetic Compatibility does not apply.

SOTA Cloud Imaging is a software product which does not have electronic components. Therefore, the requirement of Electrical Safety does not apply.

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L. Summary of Animal Performance Testing

Based on the device hazard analysis and classification SOTA Imaging has not performed animal performance testing to compare SOTA Cloud Imaging to the XV Web predicate.

M. Comparing SOTA Cloud Imaging to the XV Web predicate

The following comparison table compares SOTA Cloud Imaging to the XV Web predicate with respect to intended use, indications of use, environment of use. limitations of use, technical performance and technological characteristics and provides additional information regarding the basis for the determination of substantial equivalence.

N. SOTA Cloud Imaging and the XV Web Predicate Differences

Unlike the XV Web predicate device. SOTA Cloud Imaging does not require the installation of a separate image acquisition user interface, outside of the cloud-based web application.

None of the above-mentioned differences in features changes any of the Safety or Effectiveness or Indications for Use of SOTA Cloud Imaging as compared to the XV Web predicate.

O. Substantial Equivalence Rationale

SOTA Imaging has conducted extensive performance testing for validation and verification of SOTA Cloud Imaging and has done analysis to compare SOTA Cloud Imaging to the XV Web predicate. Based on this testing analysis SOTA Cloud Imaging provides all the capabilities necessary to operate in a manner substantially equivalent to the XV Web predicate. The comparison table compares SOTA Cloud Imaging to the XV Web predicate with respect to intended use, indications of use, environment of use, limitations of use, technical performance, and technological characteristics. The comparison chart provides additional information regarding the basis for the determination of substantial equivalence. Additionally, the results of the performance testing demonstrate that SOTA Cloud Imaging is safe and effective for its intended use. Based on the intended use, product design, performance and software information provided in this notification, SOTA Cloud Imaging is considered substantially equivalent to the currently marketed XV Web predicate.

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Comparison table

510(k) Number	K132342	K210682
Device Name	XV Web	SOTA Cloud Imaging
Classification Name	Picture Archiving andCommunicationsSystem (PACS)	Medical ImageManagementand Processing System
Common\Usual name	Dental ImagingSoftware	Dental ImagingSoftware
Manufacturer	Apteryx, Inc.	SOTA PrecisionOptics, Inc. dba SOTAImaging
Classification	Class II	Class II
Regulation Number	892.2050	892.2050
Product Code	LLZ	LLZ
Classification panel	Radiology	Radiology
Medical Specialty	Dentistry	Dentistry
Implementation	Dental Office	Dental Office
Host Platform	Web Based SoftwareApplication	Web Based SoftwareApplication
Intended Use	XV Web is a PictureArchiving andCommunicationsSystem (PACS) thatenables dental facilitiesto query and accessdigitally stored hardand soft tissue intraoral/extraoral radiologicalimages using aninternet/web browser.A web-based interfaceprovides users theneeded functionality todisplay patient imagesand studies incommercially availableweb browsers. Patientimages/studies can beaccessed by users	SOTA Cloud Imagingis indicated for use asa clinical softwareapplication thatreceives images anddata from Clio or ClioPrime x-ray sensorsand various otherimaging sources (e.g.,radiographic devices,digital video capturedevices, and genericimage devices such asscanners). In addition,SOTA Cloud Imagingenables the storage ofclinical notes andclinical exam data.It is intended toacquire, display
	locally within the	process, edit (e.g.,
	system or across a	resize, adjust contrast,
	wide-area network at	annotate, etc.), review,
	distributed locations.	store, print, and
	Acquisition can be	distribute images using
	included via integration	standard PC hardware.
	with a DICOM-	SOTA Cloud Imaging
	compatible imaging	controls the direct
	application or server	capture of digital x-ray
	configured to forward	images from Clio and
	images to the XV Web	Clio Prime intraoral x-
	database. The system	ray sensors and other
	allows users to:	FDA approved
	manipulate (e.g.,	radiographic imaging
	rotate, flip, etc.):	devices, views and
	enhance (e.g.,	captures live image
	increase or decrease	from intraoral cameras
	brightness/contrast,	via USB 2.0 or video
	gamma correction);	capture card, imports
	add labels (e.g.,	images from various
	measurements, lines,	sources such as
	arrows, etc.),	radiographic devices,
	annotations to patient	flatbed scanners,
	images/studies and	digital cameras, and
	other relevant	generic image devices,
	operations for	exports, e-mail, prints
	diagnostic purposes.	images, processes
	XV Web is designed	digital images with
	for medium-to-large	several tools to
	dental practices and is	enhance their
	intended for trained	diagnostic value, and
	dental professionals	creates a database of
	and technicians to	patients and store
	access, manipulate,	images in patient
	and enhance dental	folders on cloud server
	images for diagnostic	storage.
	purposes only.
Indications for Use	XV Web is a Picture	SOTA Cloud Imaging
	Archiving and	is indicated for use as
	Communications	a clinical software
System (PACS) thatenables dental facilitiesto query and accessdigitally stored hardand soft tissueintraoral/extraoralradiological imagesusing an internet/webbrowser. A web-basedinterface providesusers the neededfunctionality to displaypatient images andstudies in commerciallyavailable webbrowsers. Patientimages/studies can beaccessed by userslocally within thesystem or across awide-area network atdistributed locations.Acquisition can beincluded via integrationwith a DICOM -compatible Imagingand/or PACS systemconfigured to forwardimages to the XV Webdatabase. XV Web iscompatible withprograms that run onstandard "off-the-shelfpersonal computers,business computers,and servers runningstandard operatingsystems. The systemallows users to:manipulate (e.g	application thatreceives images anddata from Clio or ClioPrime sensors andvarious imagingsources (e.g.,radiographic devices,digital video capturedevices, and genericimage devices such asscanners). In addition,SOTA Cloud Imagingenables the storage ofclinical notes andclinical exam data.SOTA Cloud Imagingis intended to acquire,display, process, edit(e.g., resize, adjustcontrast, annotate,etc.), review, store,print, and distributeimages using standardPC hardware. SOTACloud Imaging is alsointended for use fordiagnostic and non-diagnostic purposes inthe field of Dentistry bydental professionalswho are responsiblefor providing dentalcare.
	rotate, flip, etc.);enhance (e.g.,increase or decreasebrightness/contrast,gamma correction);add labels (e.g.,measurements, lines,arrows, etc.),annotations to patientimages/studies andother relevantoperations fordiagnostic purposes.XV Web is designedfor medium to largedental practices and isintended for traineddental professionalsand technicians toaccess, manipulate,and enhance dentalimages for diagnostic
Features	purposes only.Browsing images bydate and/or sourceViewing an ImageUploading an Imagefile (via integration withDICOM-compatibleimaging application orPACS)Acquiring an Imagefrom a Web camera(via integration withDICOM-compatibleimaging application)	Browsing images bydate and/or sourceViewing an ImageUploading an ImagefileAcquiring an Imagefrom a Web cam
	Acquiring an Imagefrom a TWAIN device(via integration with	Acquiring an Imagefrom a TWAIN device
DICOM-compatibleimaging application)Acquiring an imagefrom standard dentalimaging devices (viaintegration withDICOM-compatibleimaging application)Copying an Image tothe local computerAdd labels andannotations on patientimages (Text, lines,arrows, ect.)Saving a ModifiedImageSaving an Image thathas been modified withlabels/overlays.Annotating an ImageZooming in on anImageInverting Colors on anImageRotating an Image(increments of 90degrees)Flipping an ImageHorizontally orVerticallyImage contrastIncrease and decreaseimage contrastIncrease and decreaseimage brightness,Adjust gamma functionN/AN/A	Acquiring an imagefrom standard dentalimaging devicesCopying an Image tothe local computerSaving a ModifiedImageAnnotating an ImageZooming in on anImageInverting Colors on anImageRotating an image(increments of 90degrees)Flipping an imageHorizontally orVerticallyN/AIncrease and decreasecontrastIncrease and decreasebrightnessAdjust gamma functionSpotlight sharpnessenhancement toolStaff audit logging
TechnicalCharacteristics
	N/A/Cropping imageInverting colors of animageWeb-based applicationand interfaceSecure datatransmission (HTTPS)DatabaseManagement andStorageSecure server andInfrastructure	Staff software-useanalyticsN/AN/AResponsive singlepage web-basedapplication andinterfaceSecure datatransmission (HTTPS,TLS v1.2)Secure DatabaseManagement andStorageSecure server andInfrastructureMulti-zone redundant,highly available
	DICOM Compliant	DICOM File Compliant
	Lossless ImageCompression	Lossless ImageCompression
	Zoom Depth, fit andrelative
	XV Web is designedfor medium to largedental practices and isintended for traineddental professionalsand technicians toaccess, manipulateand enhance dentalimages for diagnosticand non-diagnosticpurposes.	SOTA Cloud Imagingis designed for singledental practice, groupdental practice, andcorporate dentalservice organizationenvironments. SOTACloud Imaging isintended for traineddental professionalsand technicians toaccess, manipulate,and enhance dentalimages for diagnosticand non-diagnosticpurposes.

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P. Recognized Standards and Not Recognized Standard

SOTA Cloud Imaging is software that conforms to the following recognized standards.

13-79 ISO 14971: Medical Devices-Application of Risk Management to Medical Devices

5-125 IEC 62304: Medical Device Software-Software Life Cycle Processes

NR ISO 13485:2016 Medical devices -- Quality management systems -- Requirements for regulatory purposes

Q. Conclusion

Based on the comparison of intended use, indications for use and technological characteristics, SOTA Cloud Imaging is substantially equivalent to the XV Web predicate. SOTA Imaging has conducted extensive performance testing for validation and verification indicating that SOTA Cloud Imaging provides reliable post-processing information to ensure that SOTA Cloud Imaging provides all the capabilities necessary to operate in a manner substantially equivalent to the XV Web predicate.

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).