JiveX is a software only Picture Archiving and Communication System intended to display, process, read, report, communicate, distribute, store, and archive medical data which is available as DICOM or HL7 data, including mammographic images, and bio signals. JiveX also converts case related non-image documents, archives them as DICOM data and serves as a vendor neutral archive.

It supports the physician in diagnosis.

For primary image diagnosis in Mammography only uncompressed or non-lossy compressed images must be used.

Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants.

Note: Web-based image distribution and mobile device display of mammographic images are not intended for diagnostic purposes.

For users in the United States of America: Mobile device display is not intended for diagnostic purposes.

Device Description

JiveX is a PACS software, with a Moderate level of concern.

A Communication Server is communicating, storing, and archiving images, documents and signal data via DICOM. HL7 and proprietary interfaces. It also renders images for the web-based image distribution.

The fat clients can be used as workstations for medical reading and reporting. They provide extensive functions for image display and image processing. The reporting of digital mammography images is also supported.

The web-based clients are mainly intended for image distribution on personal computers and mobile devices. They offer less functions than the fat clients. As far as the functions allow for it, the web clients can also be used for reading and reporting on personal computers.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the JiveX (Model Number / Release: 5.3) Picture Archiving and Communication System (PACS).

Please note: The document explicitly states that the "subject device was found to have a safety and effectiveness profile that is similar to the predicate device" based on non-clinical performance testing. It also outlines verification and validation activities throughout development. However, the document does not contain details of specific acceptance criteria (numerical targets) or the results of a dedicated study to "prove" the device meets such criteria in comparison to a predicate device. The submission primarily focuses on demonstrating substantial equivalence to a predicate device (JiveX 5.2) without reporting a comparative clinical effectiveness study against specific performance metrics for the new release.

Therefore, many of the requested details related to quantitative acceptance criteria, a specific study proving those criteria, sample sizes used for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone performance are not available in the provided text.

Here's a breakdown of what can be extracted based on the provided information:

1. A table of acceptance criteria and the reported device performance

As mentioned above, the document does not provide a table of explicit, quantifiable acceptance criteria or reported numerical performance data from a specific study comparing the subject device to a predicate device against such criteria. The "Performance Data" section describes the verification and validation process rather than specific performance metrics and their achievement.

The conclusion states: "Based on the non-clinical performance testing the subject device was found to have a safety and effectiveness profile that is similar to the predicate device."

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

Not provided in the document. The "Performance Data" section describes general verification and validation activities but does not specify the sample sizes, data provenance, or study design (retrospective/prospective) for any test sets used to compare performance between the subject and predicate device.

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)

Not provided in the document. No specific "test set" with expert-established ground truth is detailed.

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

Not provided in the document.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. This device is a PACS system, which primarily focuses on image management and display, and not an AI-assisted diagnostic tool that would typically involve improving human reader performance.

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

This is a PACS system, a software only medical device (SaMD) for image management, display, and processing. It does not appear to be an algorithm designed for standalone diagnostic performance. The document focuses on its functions as an archiving and communication system, supporting physicians in diagnosis.

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

Not provided and not applicable given the nature of the device and the information presented. The document does not describe studies requiring "ground truth" for diagnostic accuracy.

8. The sample size for the training set

Not applicable. This is a PACS system, not a device that relies on a specific "training set" for an AI algorithm in the traditional sense of machine learning for diagnostic tasks. Its development involves software engineering principles and testing, not AI model training.

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

Not applicable as there is no mention of a training set or AI model development in the provided text.

Summary

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

Visus Health IT GmbH % Axel Schreiber, M.D., Ph.D. VP Process & Agile Services Gesundheitscampus-Süd 15-17 44801 Bochum GERMANY

September 23, 2021

Re: K212321

Trade/Device Name: JiveX (Model Number / Release: 5.3) Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: July 20, 2021 Received: July 26, 2021

Dear Dr. Schreiber:

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

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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) K212321

Device Name JiveX (Model Number / Release: 5.3)

Indications for Use (Describe)

It supports the physician in diagnosis.

For primary image diagnosis in Mammography only uncompressed images must be used.

Typical users of this system are trained professionals, including but not limited to physicians, radioal technicians, and assistants.

Note: Web-based image distribution and mobile device display of mammographic images are not intended for diagnostic purposes.

For users in the United States of America: Mobile device display is not intended for diagnostic purposes.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the text '510(k) for JiveX 5.3'. The text is written in a simple, sans-serif font and is centered on the image. The text is likely a reference to a medical device clearance process, specifically the 510(k) premarket submission to the FDA for the JiveX 5.3 software.

K212321 Section 5 "510(k) Summary"

of the Traditional 510(k) Premarket Notification Submission for the medical device JiveX, release 5.3

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92

Submitter

Manufacturer (Owner)	VISUS Health IT GmbH,Gesundheitscampus 13-1544801 Bochum, Germany
Registration Number	3007667119
Contact Person	Axel Schreiber, MD, PhDVice President Process & Agile ServicesTelephone +49 234 93693-0Email: schreiber@visus.com
Date Prepared	July 20th, 2021

Device

510(k) Number	K212321
Trade Names	JiveX
Common Name	Picture Archiving and Communication System (PACS)
Classification Panel	Radiology
CFR Section	21 CFR §892.2050
Device Class	Class II
Product Code	LLZ

Predicate Device

Predicate Device	K200703
Trade Names	JiveX
Common Name	Picture Archiving and Communication System (PACS)
Classification Panel	Radiology
CFR Section	21 CFR §892.2050
Device Class	Class II
Product Code	LLZ

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510(k) for JiveX 5.3

Device Description

JiveX is a PACS software, with a Moderate level of concern.

Indications for Use

It supports the physician in diagnosis.

For primary image diagnosis in Mammography only uncompressed or non-lossy compressed images must be used.

Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants.

Note: Web-based image distribution and mobile device display of mammographic images are not intended for diagnostic purposes.

For users in the United States of America: Mobile device display is not intended for diagnostic purposes.

Comment: A note on regulatory requirements for peripherals, that might be used with the device, has been omitted from the Indications for Use. Otherwise the Indications for Use have not changed compared to the predicate device.

Comparison of Technological Characteristics

The subject device and the predicate device have identical technological characteristics: JiveX is a software only medical device (SaMD). The communication server and the fat clients for radiology reading are implemented in Java. The web clients are implemented in java script / type script, HTML and CSS.

The software is run on the customer's own hardware. Clients run on personal computers with MS windows operating systems. Alternatively, clients may be run on a server (-farm) and can be distributed using Citrix. The mobile client runs on iPAD. The server also runs on MS Windows operating systems using server hardware either directly or via virtual machines.

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	Subject Device	Predicate Device (K200703)
Name, Release	JiveX 5.3	JiveX 5.2
Manufacturer	VISUS Health IT GmbH	Same
Indications for use	JiveX is a software only PictureArchiving and CommunicationSystem intended to display, process,read, report, communicate,distribute, store, and archivemedical data which is available asDICOM or HL7 data, includingmammographic images, and biosignals. JiveX also converts caserelated non-image documents,archives them as DICOM data andserves as a vendor neutral archive.It supports the physician indiagnosis.For primary image diagnosis inMammography only uncompressedor non-lossy compressed imagesmust be used.	JiveX is a software only PictureArchiving and CommunicationSystem intended to display, process,read, report, communicate,distribute, store, and archivemedical data which is available asDICOM or HL7 data, includingmammographic images, and biosignals. JiveX also converts caserelated non-image documents,archives them as DICOM data andserves as a vendor neutral archive.It supports the physician indiagnosis.For primary image diagnosis inMammography only uncompressedor non-lossy compressed imagesmust be used. Also monitors(displays) and printers whichreceived FDA clearance forMammography must be used.
	Typical users of this system aretrained professionals, including butnot limited to physicians,radiologists, nurses, medicaltechnicians, and assistants.Note: Web-based image distributionand mobile device display ofmammographic images are notintended for diagnostic purposes.For users in the United States ofAmerica: Mobile device display isnot intended for diagnosticpurposes.	Typical users of this system aretrained professionals, including butnot limited to physicians,radiologists, nurses, medicaltechnicians, and assistants.Note: Web-based image distributionand mobile device display ofmammographic images are notintended for diagnostic purposes.For users in the United States ofAmerica: Mobile device display isnot intended for diagnosticpurposes.
Prescr./OTC	Prescription	Same
Design /Architecture	client / server	Same
Software only	Yes. Software as a Medical Device(SaMD)	Same
Operatingsystems	Server: Win. 10 Srv. 2012/2016/2019Client: Win. 8.1/10; iOS 13, 14	Server: Win. 7/8.1/10 Srv. 2008/2012/2016/2019Client: Win. 7/8.1/10; iOS 12, 13
	Subject Device	Predicate Device (K200703)
Image anddocumentcommunication	TCP/IP, DICOM, HL7, IHE XDS,WADO-URI, proprietary internaldata transfer protocols, proprietaryinterface to accept JPEG from aniPhone via web interface	TCP/IP, DICOM, HL7, IHE XDS,WADO-URI, proprietary internalimage transfer protocol, proprietaryinterface to accept JPEG from aniPhone via web interface
Accepted ImageFormats	DICOM data + data accepted as nonDICOM and converted to DICOMfor storage: PDF, JPG, TIFF,standard and proprietary ECGformats	Same
Supportedstorage solutions	Local storage on HDD/RAID/DVD,Network: NAS, SAN, long termstorage solutions	Same
Image datacompression	JPEG 2000 lossless & lossy, ZIP,LZ4, JPEG lossy for web clientsDisplay as received: JPEG lossless& lossy, RLE, MPEG-2	Same
Web basedaccess	Desktop (not intended formammography reading). Mobiledevices (not intended for reading)	Same
Virtualization &Citrix support	Yes, VMware. Java and web clientscan be distributed via Citrix.	Same
User administr.	Centralized	Same
Workflowsupport,RIS/HISintegration	Image Call Up from RIS, PatientInformation Reconciliation,Instance Availability, receivedocuments via HL7 MDM.Supported Standards: HL7, IHE.PACS driven reading workflow.	Image Call Up from RIS, PatientInformation Reconciliation,Instance Availability, receivedocuments via HL7 MDM.Supported Standards: HL7, IHE
IHE XDS	XDS-Consumer, Integrated SourceRepository, XDS Repository	XDS-Consumer, Integrated SourceRepository
Hardware	Windows based, manufacturerindependent server, workstationsand client hardware, iPAD	Same
ImageProcessingAlgorithms	- Zoom, Pan, Rotate, Flip, Magnify- Geometrical Measurements- ROI statistics- Mammography auto shutter- 3D Cross Reference- 4D Navigation- ECG measurements- Interpolation: nearest neighbor, bi-linear, bi-cubic, Lanczos, b-spline- Filters: sharpen, CLAHE- Windowing and LUT mapping	Same
	Subject Device	Predicate Device (K200703)
ImageProcessingAlgorithms 3D	- MPR, curved MPR- Max. Int. Projection- Min. Int. Projection- Volume Rendering- MIP for tomosynthesis data (notfor diagnostic use)- 3D image registration- fused display, SUV calculation	- MPR, curved MPR- Max. Int. Projection- Min. Int. Projection- Volume Rendering- MIP for tomosynthesis data (notfor diagnostic use)- 3D image registration- fused display
Hangingprotocols	Yes	Same
Bookmarks	Yes: Captures	Same

Tabular comparison of subject and predicate device:

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510(k) for JiveX 5.3

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510(k) for JiveX 5.3

Table 1: Tabular comparison of features and specifications

Performance Data

Summary of Non-Clinical Testing

Verification and validation is done through all development phases and includes

review of requirements, software design, code .
Review and acceptance of newly implemented functionality ●
Daily build of the (intermediate) product and performance of automated tests on unit, component, x-component and UI level
Verification / validation of "off the shelf software"
Informal test run of newly developed manual test cases and of functionality on risk ●
Evaluation of selected software functionality with customers
Formal test run of all manual test cases pertaining to new or modified functionality ●
Impact testing for all changes that had been introduced ●
Extensive regression testing ●

Based on the non-clinical performance testing the subject device was found to have a safety and effectiveness profile that is similar to the predicate device.

Conclusions

While there are some differences between JiveX 5.3 and its predicate device, these differences are very minor and do not affect device substantial equivalence. JiveX 5.3 has the same basic operational principles and technical characteristics as its predicate device and it functions in the same manner. Additionally, it has the almost same indications for use. It is as safe, as effective, and performs as well as or better than its predicate device. Therefore, JiveX 3.5 is substantially equivalent to the predicate device cited within this submission

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).