Dentrix Ascend Imaging is a web-based Dental Picture Archiving and Communications Systems (PACS), i.e. dental imaging software, that enables dental care facilities to acquire, process, edit, and enhance dental images.

Dentrix Ascend Imaging provides a web-based interface for image acquisition and management of images which are used in the field of Dentistry and when operated by dental professionals who are responsible for providing dental care.

Images can be acquired from dental image acquisition devices and/or consumer imaging devices such as color digital cameras. Previously acquired images or volumes can be selected for upload directly from the user's computer.

Supported images include intraoral dental x-rays/volumes and intraoral and extraoral color images produced by intraoral video or consumer digital cameras.

Dentrix Ascend Imaging is used for diagnostic purposes in the field of dentistry. Dentrix Ascend Imaging is not intended for diagnostic use on a mobile display.

Images can be edited/enhanced (e.g. zoomed, contrast adjusted, rotated, rotated, filtered, etc...) as well as exported to standard image file formats.

Device Description

Dentrix Ascend Imaging is web-based dental image software that provides Internet access to an image library for each patient in a practice. It also provides tools for dental practices to manipulate patient images and both acquire and upload new images in industry standard formats. Images canbe annotated and tagged and are available for use. Dentrix Ascend Imaging can be accessed by the user via an internet connection and does not require traditional s oftware installation on the user's computer.

Dentrix Ascend Imaging operates from within the Google brand ChromeWeb Browser version 39.x and higher on supported Windows and Mac Operating Systems and from within the Apple brand Safari Web Browser 8.x on Apple IOS iPad devices. Dentrix Ascend Imaging requires a minimum 17" monitor for viewing images upon a Windows or MAC PC, and operates upon an iPad device with minimum 1024 X768 resolution. The iPad device can be used for non-diagnostic purposes only.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called Dentrix Ascend Imaging, a web-based Picture Archiving and Communications System (PACS) for dental imaging. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study data to prove novel safety and effectiveness.

Therefore, the document does not contain the detailed information typically found in a study demonstrating acceptance criteria for a new device's performance, especially not in a clinical context.

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is absent:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly define "acceptance criteria" in a quantitative, measurable sense for the device's diagnostic performance (e.g., sensitivity, specificity, accuracy against a gold standard). Instead, it establishes substantial equivalence by comparing its features and functions to the predicate device.

The table below summarizes the comparison between the proposed device (Dentrix Ascend Imaging) and the predicate device (Curve Image) as presented in the document, which serves as the basis for demonstrating equivalence and, implicitly, meeting "acceptance" in the context of a 510(k).

Table: Comparison of Dentrix Ascend Imaging to Predicate Device

Feature/Characteristic	Predicate Device: Curve Image (K112974)	Proposed Device: Dentrix Ascend Imaging (K151438)	Equivalence Assessment / Reported Performance
Intended Use	Internet-based, image management software (PACS) for dental offices to keep hard and soft tissue charts in digital images.	Web-based Dental PACS, i.e., dental imaging software, that enables dental care facilities to acquire, process, edit, and enhance dental images.	"Virtually identical"
Indications for Use	For diagnostic use, acquisition, editing, and storage of digital images.	For diagnostic purposes in the field of dentistry; acquisition, processing, editing, and enhancement of dental images.	"Virtually identical"
Environment of Use	Dental Offices	Dental Offices	Identical
Host Platform	Web-based Software Application	Web-based Software Application	Identical
Technical Characteristics	- Web-based application and interface - Secure data transmission (HTTPS) - Database Management and Storage - Secure server and Infrastructure	- Web-based application and interface - Secure data transmission (HTTPS) - Database Management and Storage - Secure server and Infrastructure	Identical
Key Functionality (Examples)	- Browsing images by date/source - Viewing an image - Uploading image file - Acquiring image from web camera/TWAIN/standard dental devices - Copying/Saving/Annotating modified images - Zooming, Inverting colors, Rotating, Flipping, Adjusting Brightness/Contrast - Lossless Image Compression - Zoom depth: absolute 1x, Fit, Relative - Crop Image	- Browsing images by date/source - Viewing an image - Uploading image file - Acquiring image from web camera/TWAIN/standard dental devices - Exporting/Saving/Annotating modified images - Zooming, Inverting, Rotating, Flipping, Adjusting Brightness/Contrast - Lossless Image Compression - Zoom depth: absolute 1x, Fit, Relative - Spotlight Image - Density Measurement	"Substantially all of the features and functionality." Dentrix Ascend Imaging has additional features like "Spotlight Image" and "Density Measurement" and some minor differences (e.g., "Exporting an Image" vs "Copying an Image").
Non-Clinical Performance Testing	Not detailed for predicate, but assumed similar.	"Series of non-clinical performance tests were performed." These tests "demonstrated that Dentrix Ascend Imaging is safe and effective for its intended use and its indications of use."	Passed internal validation and verification testing for reliable post-processing and display of images.
Clinical Performance Testing	Not applicable / Not mentioned.	None performed or required.	Not required for substantial equivalence in this context.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Absent. The document refers to "non-clinical performance testing" and "validation and verification testing" but does not detail the sample sizes, type of data (e.g., number of images, patient cases), or data provenance used for these internal tests. These tests are presumably internal development and verification tests rather than external clinical trials.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Absent. Since no clinical performance testing or diagnostic accuracy study is presented, the concept of "ground truth" established by experts for a test set is not applicable in this 510(k) submission. The non-clinical tests would have validated software functions against engineering specifications, not clinical outcomes.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Absent. As no clinical study involving expert interpretation is detailed, adjudication methods are not discussed.

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

Absent. No MRMC or comparative effectiveness study involving human readers or AI assistance (as a diagnostic aid) was performed or mentioned. Dentrix Ascend Imaging is described as a PACS system, primarily for image acquisition, management, and post-processing, not an AI-powered diagnostic tool that assists human readers in lesion detection or diagnosis.

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

Absent. This device is a PACS for managing and displaying images under human professional operation, not a standalone diagnostic algorithm.

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

Absent. As detailed in points 2 and 3, no clinical ground truth (expert consensus, pathology, outcomes) was established or used for performance testing. The "ground truth" for the non-clinical tests would have been the functional specifications of the software.

8. The sample size for the training set

Absent. This device is a PACS, not an AI/ML device that requires a training set of data.

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

Absent. This is not an AI/ML device and therefore does not have a training set or associated ground truth.

Conclusion on "Study":

The "study" referenced in the document is a "Summary of Non-Clinical Performance Testing," which involved "positive and negative testing against the device requirements and human factors" and "validation and verification testing." This is typical for demonstrating substantial equivalence for a PACS system, focusing on functional performance, cybersecurity, and adherence to recognized standards (ISO 14971:2007 for Risk Management, IEC 62304:2012 for Software Life Cycle Processes). It explicitly states that "No clinical performance testing has been included in this submission" and that such testing was "neither required nor performed" based on the hazard analysis and device classification. Therefore, the document does not contain the kind of detailed clinical study information often associated with proving acceptance criteria for diagnostic accuracy or safety in many other types of medical devices.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing movement or connection.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 7, 2015

RealCloud Imaging Inc. % Mark Job 1394 25TH STREET, NW BUFFALO MN 55313

Re: K151438

Trade/Device Name: Dentrix Ascend Imaging Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 26, 2015 Received: June 29, 2015

Dear Mr. Job:

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Robert A. Ochs

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

Enclosure

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Indications for Use

510(k) Number (if known) K151438

Device Name

Dentrix Ascend Imaging

Indications for Use (Describe)

Supported images include intraoral dental x-rays/volumes and intraoral and extraoral color images produced by intraoral video or consumer digital cameras.

Dentrix Ascend Imaging is used for diagnostic purposes in the field of dentistry. Dentrix Ascend Imaging is not intended for diagnostic use on a mobile display.

Images can be edited/enhanced (e.g. zoomed, contrast adjusted, rotated, rotated, filtered, etc...) as well as exported to standard image file formats.

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

Applicant Information: I.
Corporate Name: RealCloud Imaging Inc.

Corporate Address: 2060 Alameda Padre Serra, Suite 100 Santa Barbara, California 93013 Date Prepared: June 30, 2015 Submitter: W. Edward Johansen, Official Correspondent Telephone Number: (310) 795-7425 E-mail address: wedjohansen@msn.com

II. Device Name and Classification
Proprietary Name: Dentrix Ascend Imaging

Classification Name: Picture Archiving and Communications System

Common/Usual Name: Dental Imaging Software (PACS)

Classification: II

Regulation Number: 21 C.F.R. 892.2050

Product Code: LLZ

Classification Panel: Radiology

III. Predicate Device
Dentrix Ascend Imaging is substantially equivalent to the following FDA cleared predicate device with regard to indications for use, performance and technological characteristics:

510(k) Number: K112974

Trade Name: Curve Image

Manufacturer: Curve Dental, Inc.

Classification Name: Picture Archiving and Communications System

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Common/Usual Name: Dental Imaging Software (PACS)

Classification: Class II

Regulation Number: 21 C.F.R. 892.2050

Product Code: LLZ

The following table compares Dentrix Ascend Imaging to the predicate device Curve Image with respect to intended use, indications for use environment of use, limitations of use, technical performance and technological characteristics and provides more detailed information regarding the basis for the determination of substantial equivalence.

510(k) Number	K112974	K151438	Browsing Images by Dateand/or Source	Browsing Images by Dateand/or Source
Trade Name	Curve Image	Dentrix Ascend Imaging	Viewing an Image	Viewing an Image
Manufacturer	Curve Dental, Inc	RealCloud Imaging Inc.	Uploading and Image file	Uploading and Image file
Classification Name	Picture Archiving andCommunication System	Picture Archiving andCommunication System	Acquiring an Image from aWeb camera	Acquiring an Image from aWeb camera
Common/Usual Name	Dental Imaging Software	Dental Imaging Software	Acquiring an Image from aTWAIN device	Acquiring an Image from aTWAIN device
Classification	Class II	Class II	Acquiring an image fromstandard dental imagingdevices	Acquiring an image fromstandard dental imagingdevices
Regulation Number	21 C.F.R. 892.2050	21 C.F.R. 892.2050	Copying an Image to theLocal Computer	Copying an Image to theLocal Computer
Product Code	LLZ	LLZ	Saving a Modified Image	Saving a Modified Image
Classification Panel	Radiology	Radiology	Annotating an Image	Annotating an Image
Implementation	Dental Offices	Dental Offices	Zooming in on an Image	Zooming in on an Image
Host Platform	Web-based SoftwareApplication	Web-based SoftwareApplication	Inverting Colors on anImage	Inverting Colors on anImage
Indications for Use	Curve Image	Dentrix Ascend Imaging	Rotating an Image(increments of 90 degrees)	Rotating an Image(increments of 90 degrees)
	Curve Image is an internet-based, image managementsoftware (PACS) that enablesdental offices to keep hardand soft tissue charts in aform of digital images.	Dentrix Ascend Imaging is aweb-based Dental PictureArchiving and CommunicationsSystems (PACS), i.e. dentalimaging software, that enablesdental care facilities to acquire,process, edit, and enhancedental images.	Flipping an ImageHorizontally or Vertically	Flipping an ImageHorizontally or Vertically
	Curve uses a Web-basedinterface and includesacquisition, editing, andstorage of digital images.	Dentrix Ascend Imagingprovides a web-based interfacefor image acquisition andmanagement of images whichare used in the field of Dentistryand when operated by dentalprofessionals who areresponsible for providing dentalcare.	Increasing/DecreasingBrightness	Increasing/DecreasingBrightness
	Images and data can bestored, communicated,processed, and displayedwithin the system or acrosscomputer networks atdistributed locations.	Images can be acquired fromdental image acquisitiondevices and/or consumerimaging devices such as colordigital cameras. Previouslyacquired images or volumescan be selected for uploaddirectly from the user'scomputer.	Increasing/DecreasingContrast	Increasing/DecreasingContrast
	Images can be acquired fromstandard dental imagingdevices or can be uploadeddirectly from the user'scomputer.	Supported images includeintraoral and extraoral dental x-rays/volumes and intraoral andextraoral color images producedby intraoral video or consumerdigital cameras.	Adjusting Gamma Function	Adjusting Gamma Function
	Images can be edited (e.g.,zoomed, contrast, rotated,etc.) as well as exported.	Dentrix Ascend Imaging is usedfor diagnostic purposes in thefield of dentistry. DentrixAscend Imaging is not intendedfor diagnostic use on a mobiledisplay.	Lossless ImageCompression	Lossless ImageCompression
	The system is designed toprovide images for diagnosticuse.	Images can be edited/enhanced(e.g. zoomed, contrast adjusted,inverted, annotated, rotated,filtered, etc...) as well asexported to standard image file	Zoom depth: absolute 1x,Fit and Relative	Zoom depth: absolute 1x,Fit and Relative
	Crop Image	NA
	NA	Spotlight Image
	NA	Density Measurement

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Technical Characteristics	Web-based applicationand interface	Web-based applicationand interface
	Secure data transmission(HTTPS)	Secure data transmission(HTTPS)
	Database Managementand Storage	Database Managementand Storage
	Secure server andInfrastructure	Secure server andInfrastructure

The indications of use, features and technical characteristics of Dentrix Ascend Imaging and Curve Image are virtually identical.

Based on the comparison of use, indications of use, and technological characteristics Dentrix Ascend Imaging (K151438) is substantially equivalent to Curve Image (K112974) manufactured by Curve Dental, Inc. Dentrix Ascend Imaging includes the web-based technology and substantially all of the features and functionality of Curve Image. Dentrix Ascend is substantially equivalent to the predicate Curve Image.

Device Description

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Technical Overview

Dentrix Ascend Imaging is a web based imaging program. On the serverside Ascend Imaging is written in the C# language and runs on the Microsoft Windows Server 2012 R2 operating system. Ascend Imaging uses SQL to store and retrieve data from a Microsoft SQL Server 2014 database. Ascend Imaging is hosted on a Microsoft IIS server. The Ascend Imaging server technology is hosted entirely on virtual machine image. On the client side Ascend Imaging ishosted in a compatible HTML5 web browser and is written in HTML5,CSS3, and Java Script.

Off-the-Shelf Software

Dentrix Ascend Imaging does not distribute or contain any Off-the-Shelf software. An OTS operating system such as Windows or Mac OSX is commonly used in conjunction with an OTS web browser such as Google Chrome to interface the user, hardware platform and the Dentrix Ascend Imaging software. Off-the-Shelf software represents no threat of direct harm to the patient. The risk of indirect harm from lack of diagnostic information relating to off-the-shelf software-malfunction is small since the operator can use traditional methods to investigate and diagnose the patient. The OTS Software in this medical device thus represents a Minor Level of Concern and should satisfybasic documentation.

Level of Concern

RealCloud Imaging Inc. has determined that the level of concern for the Dentrix Ascend Imaging software is Moderate according to the analysis in Section23, subsection A of this 510(k)submission.

Intended Use

Dentrix Ascend Imaging is a web-based Picture Archiving and Communications Systems (PACS), dental imaging software, that enables dental care facilities to acquire, process, edit, and enhance dental images. Dentrix AscendImaging provides a web-based interface for image acquisition and management of images which are used in the field of Dentistry when used by dental professionals who are responsible for providing dental care.

Supported image types include intraoral and extraoral dental x-rays, intraoral and extraoral color images, and three dimensional volumes of dental anatomy. Images can be acquired from dental image acquisition devices and/or consumer imaging devices such as color digital cameras. Previously acquired images or volume scan be selected for upload directly from the user's computer. Images can be edited/ enhanced (e.g. zoomed, contrast adjusted, inverted, annotated, rotated, filtered,

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etc ... ) as well as exported to standard image file formats.

Summary of the Technical Characteristics:

Dentrix Ascend Imaging provides the following high-level features:

Browsing Images by Date and/or Source
Viewing an Image ●
Uploading an Image File ●
. Acquiring Image from a Web Camera
Acquiring an Image from a TWAIN Device ●
. Acquiring image from Dental Imaging Device
Exporting an Image to the Local Computer/other location
Saving a Modified Image .
Annotating an Image .
. Zooming In on an Image
Inverting colors of an Image
Rotating an Image (increments of 90 degrees)
Flipping an Image Horizontally or Vertically
Increasing/Decreasing Image Brightness
Increasing/Decreasing Image Contrast ●

The main technical characteristics of the softwareare:

Web-based Application and Interface
. Secure Data Transmission (HTTPS)
. Database Management and Storage
o Secure Server Infrastructure

Summary of Non-Clinical Performance Testing

A series of non-clinical performance tests were performed. The results of the non-clinical performance testing. which included positive and negative testing against the device requirements and human factors, demonstrated that Dentrix Ascend Imaging is safe and effective for its intended use and its indications of use.

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This device conforms to the following recognized standards. A Standards Data Report is included below for each standard.

ISO 14971:2007 Medical Devices- Application of Risk Management o to Medical Devices

IEC 62304:2012 Medical Device Software Software Life Cycle Processes o
Based on the intended use, product design, performance and software information provided in this notification, the subject device is considered tobe substantially equivalent to the currently marketed predicate device.

Non-clinical performance testing (bench testing) has been performed on this software product. Test information can be located within the Software section of this submission.

RealCloud Imaging Inc. has conducted extensive non-clinical performance testing and validation and verification testing of Dentrix Ascend Imaging as a Picture Archiving and Communications System (PACS) that is capable of providing reliable post-processing and display of images for dental applications. All of the different components of the Ascend Imaging have been stress tested to ensure that Dentrix Ascend Imaging as a whole provides all the capabilities necessary to operate in a manner substantially equivalent to the predicate device.

Non-Applicable Requirements

No animal performance testing has been included in this submission. Based on the device hazard analysis and classification of the device animal performance testing was neither required nor performed.

No clinical performance testing has been included in this submission.

Based on the device hazard analysis and classification of the device clinical performance testing was neither required nor performed.

Dentrix Ascend Imaging is a software product. Therefore, the requirement for Sterilization does not apply.

Dentrix Ascend Imaging is a software product. Therefore, the requirement for specifying Shelf Life does not apply. Dentrix Ascend Imaging contain patient contacting materials. Therefore, the requirement for Biocompatibility does not apply.

Dentrix Ascend Imaging is a software product which does not contain any electronic components. Therefore, the requirement for Electromagnetic Compatibility and Electrical Safety does not apply.

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Conclusions

Based on the comparison of intended use, indications for use, andtechnological characteristics Dentrix Ascend Imaging (K151438) is substantially equivalent to Curve Image (K112974) manufactured by Curve Dental, Inc. Dentrix Ascend Imaging includes the web-based technology andsubstantially all of the features and functionality of Curve Image. Dentrix Ascend Imaging is substantially equivalent to the predicate Curve Image.

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).