ONIS-PACS is a software device intended to be used by healthcare personnel and intended for viewing, reviewing, performing measurements/quantifications and reporting of medical images and data acquired from DICOM compliant medical imaging systems. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy images and digitized film images must not be used for primary diagnosis or interpretation.

Device Description

ONIS-PACS is a Picture Archiving Communication System (PACS) fully compliant with the DICOM version 3.0 Standard. It is suitable for storing, distributing, retrieving, visualizing, manipulating, performing measurements/quantifications and reporting various DICOM objects. ONIS Viewer is a desktop application that makes it possible to visualize, manipulate and process medical images of many different modalities. Basic and advanced tools are provided for manipulating and processing images, including multi-planar reconstruction and 3D volume rendering. The software also includes a Local Server service running in the background that can send and receive DICOM images and can respond to DICOM queries. The ONIS Viewer and the Local Server applications must run on the same computer. ONIS Remote is a desktop application identical to the ONIS Viewer, except that it runs without the Local Server. It must connect to a Site Server to retrieve the studies to be retrieved and processed. WebONIS is an ActiveX component loaded into an HTML page that provides the same functionality as the ONIS Remote application. It can only be used with the Microsoft Internet Explorer browser. The browser must connect to a web server to load the ActiveX component, and the latter then connects directly to an ONIS Site Server or an ONIS Organization Server. ONIS Site Server is a server application that supports the storage and retrieval of a wide range of DICOM Storage objects. It also supports the storage and retrieval of graphical annotations and reports when connected to ONIS client applications (ONIS Viewer, ONIS Remote, and WebONIS). ONIS Organization Server is a server that provides a single access point to multiple Site Servers.

AI/ML Overview

This Premarket Notification (510k) Summary for ONIS-PACS does not include detailed acceptance criteria or a dedicated study showing the device meets specific performance criteria. Instead, it relies on substantial equivalence to an existing predicate device (iQ-System PACS) based on similar indications for use and technological characteristics.

However, it does state that "Software Validation and Verification testing was performed on the ONIS-PACS device to demonstrate safety and effectiveness." The summary does not provide specific details about these tests, the acceptance criteria used, or the results.

Therefore, many of the requested details cannot be extracted directly from the provided text.

Based on the available information, here's what can be inferred:

1. Table of Acceptance Criteria and Reported Device Performance

As specific performance acceptance criteria and reported numerical performance values are not provided in this 510(k) summary, this table cannot be populated as requested. The document emphasizes substantial equivalence rather than presenting discrete performance metrics against predefined criteria.

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

Not explicitly stated. The document mentions "Software Validation and Verification testing," which implies a test set was used, but details on its size, origin (country), or whether it was retrospective or prospective are absent.

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

Not explicitly stated. Given that the testing focuses on software validation and verification for a PACS system, ground truth might relate to technical specifications, image integrity, and functional correctness rather than clinical diagnosis. If clinical performance was assessed (which is not described), then expert review would be relevant, but details are not provided.

4. Adjudication method for the test set

Not explicitly stated.

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, an MRMC comparative effectiveness study is not mentioned. The device is a Picture Archiving and Communication System (PACS) and the comparison is largely about its functional similarity to another PACS system, not directly about improving human reader performance with AI assistance. The document does not describe AI components in the ONIS-PACS.

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

No, this level of detail is not provided. The "Software Validation and Verification testing" likely encompasses standalone software performance, but no specific study design or results are presented.

7. The type of ground truth used

Not explicitly stated. For a PACS system, ground truth for software validation would typically involve verifying that images are displayed correctly, measurements are accurate, data is stored and retrieved properly, and functionalities match specifications. It's unlikely to involve clinical outcomes or pathology in the context of this 510(k) summary for a PACS.

8. The sample size for the training set

Not applicable. The document does not describe a machine learning or AI component that would require a dedicated training set. The "Software Validation and Verification testing" would involve testing the software's functionality, not training a model.

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

Not applicable, as there is no mention of a training set for a machine learning model.

Summary Statement from the Document:

The most relevant statement regarding performance and acceptance criteria is: "Software Validation and Verification testing was performed on the ONIS-PACS device to demonstrate safety and effectiveness." This indicates that the software was tested to ensure it operates as intended and meets its non-clinical functional requirements, consistent with a "moderate level of concern" software as per FDA guidance. The successful completion of these tests serves as the proof that the device meets the necessary criteria for its intended use, based on the principle of substantial equivalence to the predicate device.

Summary

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August 13, 2018

Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

DigitalCore Co., Ltd % Esin Yesilalan Senior Regulatory Scientist Voisin Consulting, Inc. 222 Third St. Suite 3121 CAMBRIDGE MA 02142

Re: K181318

Trade/Device Name: Onis-Pacs Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: May 17, 2018 Received: May 18, 2018

Dear Esin Yesilalan:

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; medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices

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or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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,

Michael D. O'Hara
For

Robert A. Ochs, Ph.D. 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) K181318

Device Name ONIS-PACS

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

I. Submitter Information

Company Name:	DigitalCore Co.,ltd
Company Address:	Setagaya-ku Kinuta 5-8-31Ginga-M2157-0073 Tokyo, Japan
Company Phone:	Tel: +81 (3) 5727-1064
Company Fax:	+81 (3) 5727-1065
Contact Person:	Cedric Lemoigne, DigitalCore Directorcedric@dgcore.co.jp+81-90-5335-8104 (Japan) +33-7-68-58-52-25 (France)
Date the summary was prepared:	August 7, 2018

II. Device Identification

Trade Name:	ONIS-PACS
Common Name:	Picture Archiving and Communication System
Classification Name:	System, Image Processing, Radiological
Product Code:	LLZ
Regulation Number:	892.2050
Device Class:	Class II

III.Identification of Predicate Devices

Device Name	iQ-System PACS
Manufacturer	IMAGE Information Systems Ltd
510(k) Number	K062488
Regulatory Class	Class II
Common Name	Picture Archiving and Communication System
Clearance Date	Sep 19 2006

IV. Device Description

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ONIS Viewer is a desktop application that makes it possible to visualize, manipulate and process medical images of many different modalities. Basic and advanced tools are provided for manipulating and processing images, including multi-planar reconstruction and 3D volume rendering. The software also includes a Local Server service running in the background that can send and receive DICOM images and can respond to DICOM queries. The ONIS Viewer and the Local Server applications must run on the same computer.

ONIS Remote is a desktop application identical to the ONIS Viewer, except that it runs without the Local Server. It must connect to a Site Server to retrieve the studies to be retrieved and processed.

WebONIS is an ActiveX component loaded into an HTML page that provides the same functionality as the ONIS Remote application. It can only be used with the Microsoft Internet Explorer browser. The browser must connect to a web server to load the ActiveX component, and the latter then connects directly to an ONIS Site Server or an ONIS Organization Server.

ONIS Site Server is a server application that supports the storage and retrieval of a wide range of DICOM Storage objects. It also supports the storage and retrieval of graphical annotations and reports when connected to ONIS client applications (ONIS Viewer, ONIS Remote, and WebONIS).

ONIS Organization Server is a server that provides a single access point to multiple Site Servers.

V. Indications for Use

VI. Comparison to Predicate Devices

Device Name	New Device	Predicate Device	Comparison
Manufacturer	DigitalCore	IMAGE InformationSystems Ltd	-
510(k) Number	To be assigned	K062488	-
Regulatory Class	Class II	Class II	EQUIVALENT
Regulation Number	21 CFR 892.2050	21 CFR 892.2050	EQUIVALENT
Product Code	LLZ	LLZ	EQUIVALENT
Device Name	New Device	Predicate Device	Comparison
Common Name	Picture ArchivingCommunications System	Picture ArchivingCommunications System	EQUIVALENT
Clearance Date	To be assigned	Sep 19 2006	-
Indications for Use	ONIS-PACS is asoftware device intendedto be used by healthcarepersonnel and intendedfor viewing, reviewing,performingmeasurements/quantifications and reporting ofmedical images and dataacquired from DICOMcompliant medicalimaging systems.Images and data can bestored, communicated,processed and displayedwithin the system oracross computernetworks at distributedlocations.Lossy images anddigitized film imagesmust not be used forprimary diagnosis orinterpretation.	iQ-System PACS is asoftware device intendedfor viewing of imagesacquired from CT, MR,CR, DR, US and otherDICOM compliantmedical imaging systemswhen installed onsuitable commercialstandard hardware.Images and data can becaptured, stored,communicated,processed, anddisplayed within thesystem and or acrosscomputer networks atdistributed locations.Lossy compressedmammographic imagesand digitized film screenimages must not bereviewed for primarydiagnosis or imageinterpretation. It is theUser's responsibility toensure monitor quality,ambient light conditions,and image compressionratios are consistent withclinical application.	EQUIVALENT - Bothdevices are softwareonly devices intended toallowclinicians to view andprocess DICOM images,and communicate resultsover a network.Both devices providesupport formammographic images,and both devices contra-indicate that lossyimages should not beused for primarydiagnosis norinterpretation.
Prescription device	YES	YES	EQUIVALENT
Environment of Use	Prescription device,intended for use in ahealthcare setting	Prescription device,intended for use in ahealthcare setting	EQUIVALENT
Technological characteristics
System Architecture	Software only device,comprises workstationand web software, aswell as server software.	Software only device,comprises workstationand web software, aswell as server software.	EQUIVALENT
Operating System	Windows 7, 8, 10Microsoft Windows 2008Server StandardMicrosoft Windows 2012Server Standard	Windows 2000 / XP	EQUIVALENT - Thesubject device works onnewer versions of thesame Microsoft WindowsOperatingSystem
Device Name	New Device	Predicate Device	Comparison
Data Access andCommunication	Accesses DICOM dataon removable media(USB drive, optical disk),local and network drives,and also accessesDICOM data fromDICOM serverapplications usingDICOM communicationprotocols	Accesses DICOM datafrom portable media aswell as through serverapplications usingDICOM communicationprotocols	EQUIVALENT - Bothdevice access data usingStandard DICOMprotocols
Image file import	YES	YES	EQUIVALENT
Patient CD/DVD import	YES	YES	EQUIVALENT
Export to a portablememory	YES, Export to memorystick, optical media	YES , Export to memorystick	EQUIVALENT
Image export to imagefile or AVI video file	YES	YES	EQUIVALENT
Mammography Display	YES	YES	EQUIVALENT
Image Visualization	Supports 2D,Mammography, MultiPlanar Reconstruction(Axial, Sagittal, Coronal,Oblique, DoubleOblique), MaximumIntensity Projection andVolume Rendered views	Supports mammographydisplay, Orthogonal andOblique Multi PlanarReconstruction,Maximum IntensityProjection, SurfaceShaded Display andVolume Rendered views	EQUIVALENT - Bothdevices supportstandard image andvolume rendering views
Support for HangingProtocols	YES	YES	EQUIVALENT
Annotation Tools	Supports text, arrow,angle, line and otheruser drawn region ofinterest shapes	Support for standardannotation tools	EQUIVALENT - Bothdevices provide standardannotation tools
Measurement Tools	Supports distance andangle measurements,and pixel statistics foruser drawn regions ofinterest	Supports advancedmeasurement toolsincluding Region ofInterest computations	EQUIVALENT - Bothdevices provide standardmeasurement tools
Image ManipulationTools (Windowwidth/level, Pan, Zoom,etc.)	Provides tools forwindow width/level, pan,zoom, rotate, color LUT,opacity table, imagefilters	Provides tools forwindow width/level, pan,zoom, rotate, imagefilters, volume croppingand clipping, and othervolume rendering color,transparency and lightsetting options	EQUIVALENT - Bothdevices provide standardimage manipulationfunctionality
Data Output	Supports export ofimages to various imageformats, and printing ofimages and reports.	Supports export ofsecondary captureimages to the localimagebox, filesystem orPACS	EQUIVALENT - Bothdevices support export ofimages tomultipledestinations
Device Name	New Device	Predicate Device	Comparison
Review report	YES (HTML format)	YES (SR formats)	EQUIVALENT - Bothdevices support reportgeneration functionality,though the specificreport format may bedifferent
Windows print	YES	YES	EQUIVALENT
JPEG lossy/losslesscompression	YES	YES	EQUIVALENT
Edit patientdemographics	YES	YES	EQUIVALENT - Bothdevices allow for edit ofpatient demographics.ONIS-PACS implementstechnical controls toensure thatonly authorized userscan make thesemodifications.
DICOM Query/ Retrieve,DICOM Print	YES	YES	EQUIVALENT

The table below summarizes the comparison between the ONIS-PACS and the iQ-System.

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Both ONIS-PACS and the predicate device have similar technological characteristics, and any differences are only related to the specific software implementation.

VII. Performance Testing

Like the predicate device. ONIS-PACS is a software only medical device. The ONIS- PACS was determined to present a moderate level of concern per the FDA guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11, 2005". Software Validation and Verification testing was performed on the ONIS-PACS device to demonstrate safety and effectiveness.

VIII. Conclusion

The subject device has the same intended use as the predicate device, and differences in technological characteristics do not raise different questions of safety and effectiveness. On this basis, ONIS-PACS is substantially equivalent to the legally marketed 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).