Agfa HealthCare's Enterprise Imaging XERO Viewer 8.1 is a software application used for reference and diagnostic viewing of multi-specialty medical imaging and non-imaging data with associated reports and, as such, fulfills a key role in the Enterprise Imaging solution. XERO Viewer 8.1 enables healthcare professionals, including (but not limited to) physicians, surgeons, nurses, and administrators to receive and view patient images, documents and data from multiple departments and organizations within one multi-disciplinary viewer. XERO Viewer 8.1 allows users to perform image manipulations (including window/level, markups, 3D visualization) and measurements.

When images are reviewed and used as an element of diagnosibility of the trained physician to determine if the image quality is suitable for their clinical application. Lossy compressed mammography images and digitized film images should not be used for primary image interpretation. Uncompressed "for presentation" images may be used for diagnosis or screening on monitors that are FDA-cleared for their intended use.

XERO Viewer 8.1 can optionally be configured for Full Fidelity Mobile, which is intended for mobile diagnostic use, review and analysis of CR, DX, CT, MR, US, ECG images and medical reports. XERO Viewer Full Fidelity Mobile is not intended to replace full diagnostic workstations and should only be used when there is no access to a workstation. XERO Viewer Full Fidelity Mobile is not intended for the display of mammography images for diagnosis.

Device Description

Enterprise Imaging XERO Viewer is a web based software application used for reference and diagnostic viewing of multi-specialty medical imaging and non-imaging data with associated reports and documents. It is a picture archiving and communication system (PACS), product code LLZ, intended to provide an interface for the display, annotation, review, printing, storage and distribution of multimodality medical images, reports and demographic information for review and diagnostic purposes within the system and across computer networks. XERO Viewer enables authenticated users to search for and display patient studies (reports and images) using a web browser, user's do not need to download or install any additional software or plug-ins to use XERO Viewer.

It is the successor to Agfa's ICIS View predicate (K143397) and adds the following new functionality: it adds Xtended study viewing) desktop diagnostic support for additional modalities, supports Xtend 3D visualization and ECG mobile (Full Fidelity) diagnostic support utilizing the newer iPad version.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details from the provided document, addressing your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria (e.g., minimum accuracy percentages, specific measurement tolerances) typically found in performance studies for diagnostic devices. Instead, the "acceptance criteria" are implied to be the successful demonstration of equivalence in image quality and functionality compared to predicate devices, as assessed by qualified medical professionals.

Acceptance Criterion (Implied)	Reported Device Performance
Equivalent Diagnostic Image Quality	Qualified radiologists provided an overall score evaluating diagnostic image quality as equivalent when comparing XERO Viewer to the Enterprise Imaging Diagnostic Desktop (K142316).
Equivalent ECG Viewing and Functionality on Mobile (iPad)	Validation and non-clinical (bench) testing confirmed that ECG viewing (DICOM and PDF), layout changes, waveform adjustments, and tools (zoom, measurements) performed consistently between desktop and iPad mobile platform.
Met Performance, Safety, Usability, and Security Requirements	Verification and validation testing confirmed the device meets these requirements. (No specific metrics provided).
Conformance to Standards (ISO, IEC, ACR/NEMA)	Agfa's in-house standard operating procedures, used for development, conform to listed standards (ISO 13485:2003, ISO 14971:2012, ISO 27001:2013, ISO 62366:2007, IEC 62304:2006, ACR/NEMA PS3.1-3.20: 2011 DICOM).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Image Quality Evaluation: An average of 5 or 6 imaging studies per modality were evaluated for comparing diagnostic image quality. The modalities are listed as CR, DX, CT, MR, US, ECG implicitly through the device's stated capabilities and predicate comparisons.
Sample Size for ECG Viewing: Not specified beyond "users were asked to display ECG's."
Data Provenance: Not explicitly stated, but it is implied to be retrospective as the evaluation involved existing "imaging studies" and the document explicitly states "No animal or clinical studies were performed in the development of the new device. No patient treatment was provided or withheld."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Number of Experts: Not explicitly stated how many "qualified radiologists" or "qualified medical professionals" were involved. The phrasing "qualified radiologists were asked to provide an overall score" suggests multiple, but a specific number is not given.
Qualifications of Experts: Described as "qualified medical professionals" and "qualified radiologists." No specific years of experience or sub-specialties are mentioned.

4. Adjudication Method for the Test Set

The document states that "Qualified radiologists were asked to provide an overall score when comparing the diagnostic image quality..." It does not describe an explicit adjudication method (e.g., 2+1, 3+1). The "overall score" suggests a consensus or individual assessment without a detailed adjudication process mentioned for resolving discrepancies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size

No, an MRMC comparative effectiveness study was not explicitly done in the traditional sense. The study compared the image quality of the XERO Viewer against a predicate diagnostic desktop using qualified radiologists, but it was to establish equivalence, not to measure an improvement in human reader performance with AI assistance versus without AI assistance. The device itself is a viewer, not an AI-assisted diagnostic tool. Therefore, there is no effect size reported for human readers improving with AI vs. without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

Not applicable in the context of typical AI device standalone performance. The device is a "Picture archiving and communications system (PACS)" and a "software application used for reference and diagnostic viewing." It's an image viewer, not a standalone diagnostic algorithm that would typically generate its own interpretations without human intervention. The performance evaluations focused on the quality and functionality of the viewer itself for human use.

7. The Type of Ground Truth Used

The "ground truth" for the image quality evaluation was based on the expert judgment of qualified radiologists comparing the diagnostic image quality between the new viewer and an existing FDA-cleared diagnostic desktop. For the ECG viewing, the ground truth was implied by the consistent performance and functionality when compared to the desktop version. No pathology, outcomes data, or other objective "ground truth" standards were mentioned.

8. The Sample Size for the Training Set

Not applicable. The document explicitly states, "No clinical trials were performed in the development of the device," and "No animal or clinical studies were performed in the development of the new device." This device is a PACS viewer, not an AI/machine learning algorithm that typically requires a discrete training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As a viewing device and not an AI/ML algorithm requiring a training set, the concept of establishing ground truth for a training set does not apply here.

Summary

{0}------------------------------------------------

Public Health Service

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus, with three human profiles forming the staff of the symbol.

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

July 3, 2017

Agfa HealthCare N.V. % ShaeAnn Cavanagh, RAC Regulatory Affairs Manager, North America Agfa HealthCare Corporation 10 South Academy Street GREENVILLE SC 29601

Re: K170434

Trade/Device Name: Enterprise Imaging XERO Viewer 8.1 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 30, 2017 Received: May 31, 2017

Dear Ms. Cavanagh:

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

{1}------------------------------------------------

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.

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/ResourcesforYou/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,

Robert Ochs

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

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K170434

Device Name

Enterprise Imaging XERO Viewer 8.1

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)
---------------------------------------------------------------------------------------------------------------------------------------------	--------------------------------------------------------------------------------------------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(K) SUMMARY:

Agfa HealthCare's Enterprise Imaging XERO Viewer

I. SUBMITTER

Agfa HealthCare N.V. Septestraat 27 B-2640 Mortsel Belgium Contact: Jodi Coleman, Prepared: February 10, 2017 Telephone: 519-746-6210 ext 2485

II. DEVICE

Name of Device: Enterprise Imaging XERO Viewer 8.1 Common Name: System, Image Processing, Radiological Classification Name: Picture Archiving and Communications System (PACS) Regulatory Classification: Class II, 21 CFR 892.2050 Product Code: LLZ

III. PREDICATE DEVICES

This is a 510(k) for Agfa's Enterprise Imaging, which is a picture archiving and communications system. It is substantially equivalent to Carestream Health's Vue Motion (K151774) and Agfa HealthCare's ICIS View (K143397).

These predicate devices have not been subject to a design-related recall.

IV. DEVICE DESCRIPTION

{4}------------------------------------------------

The only difference of the new device and the primary predicate device, Carestream Vue Motion (K151774) is the new device does not support mobile diagnostic viewing on other handheld devices other than an iPad. Differences in devices do not alter the intended diagnostic effect.

Principles of operation and technological characteristics of the new and predicate devices are the same.

INTENDED USE

Agfa HealthCare's Enterprise Imaging XERO Viewer 8.1 is a software application used for reference and diagnostic viewing of multi-specialty medical imaging and non-imaging data with associated reports and documents and, as such, fulfills a key role in the Enterprise Imaging solution. XERO Viewer 8.1 enables healthcare professionals, including (but not limited to) physicians, surgeons, nurses, and administrators to receive and view patient images, documents and data from multiple departments and organizations within one multidisciplinary viewer. XERO Viewer 8.1 allows users to perform image manipulations (including window/level, markups, 3D visualization) and measurements.

When images are reviewed and used as an element of diagnosis, it is the responsibility of the trained physician to determine if the image quality is suitable for their clinical application. Lossy compressed mammography images and digitized film images should not be used for primary image interpretation. Uncompressed or non-lossy compressed "for presentation" images may be used for diagnosis or screening on monitors that are FDA-cleared for their intended use.

XERO Viewer 8.1 can optionally be configured for Full Fidelity Mobile, which is intended for mobile diagnostic use. review and analysis of CR, DX, CT, MR, US, ECG images and medical reports. XERO Viewer Full Fidelity Mobile is not intended to replace full diagnostic workstations and should only be used when there is no access to a workstation. XERO Viewer Full Fidelity Mobile is not intended for the display of mammography images for diagnosis.

Intended use has not changed as a result of any labeling modification(s).

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH V. PREDICATE DEVICES

Agfa's Enterprise Imaging XERO Viewer has an Indications For Use statement similar to predicate devices (K151774, K143397)). The statements have been combined and simplified. The devices have the same technological characteristics.

{5}------------------------------------------------

Both XERO Viewer and the primary predicate device, Carestream Vue Motion (K151774) are used to display medical images for diagnostic purposes of multiple modalities. Both provide wireless and portable access to medical images on select validated mobile devices. Furthermore, XERO Viewer Full Fidelity and Vue Motion contain a statement that it is not intended to replace full diagnostic workstations and should only be used when there is no access to a workstation. XERO Viewer and Vue Motion (K151774) are indicated to allow image manipulations, 3D viewing capabilities and display lossylossless images. Both XERO Viewer and Vue Motion (K151774) require the use of FDA approved display hardware for primary interpretation and review of mammography images.

The devices have the same technological characteristics. The new device and the predicate devices (K151774, K143397) are picture archiving and communication systems (PACS), Product Code LLZ. Agfa's XERO Viewer system is substantially equivalent to the predicate devices (K151774, K143397) in that it uses precisely the same technology to capture and display medical data.

Descriptive characteristics and performance data including image quality evaluations by qualified radiologists are adequate to ensure equivalence. Differences in devices do not alter the intended therapeutic/diagnostic effect.

Table 1 on the next page summarizes the similarities and differences between the new device and predicates.

{6}------------------------------------------------

	Enterprise ImagingXERO ViewerNEW DEVICE	Carestream VueMotion(K151774)PRIMARYPREDICATE	Agfa HealthCare'sICIS View(K143397)
Communication	Same as predicates	DICOM	DICOM
Modalities	Including CR, DX, CT, MR, US, ECG	Including CR, DR, CT,MR, NM, US, ECG	CR, DX, CT, MR, US
Modalities Full FidelityMobile Diagnostic	CR, DX, CT, MR, US, ECG	Including CR, DR, CT,MR, NM, US, ECG	CR, DX, CT, MR, US
Mammography Use	Same as primary predicate	Yes	No
Mobile Device Supportfor Diagnostic Viewing	iPads	iPads, iPhones,Galaxy Note, Galaxy S	iPads
Transfer/Storage/Displayof Medical Images	Same as predicates	Yes	Yes
Network Access	Web browser connects to existingPACS	Web browser connectsto existing PACS	Web browser connects toexisting PACS
User Authentication	Same as primary predicate	Yes	Yes
Window Level	Same as primary predicate	Yes	Yes
Rotate/Pan/Zoom	Same as primary predicate	Yes	Yes
Measurement	Same as primary predicate	Yes	Yes
Annotation	Same as primary predicate	Yes	Yes
3D Visualization	Same as primary predicate	Yes	No
Indications for Use	Software application used for referenceand diagnostic viewing ofmultispecialty medical imaging andnon-imaging data with associatedreports and documents and, as such,fulfills a key role in the Enterprise	Program is used forpatient management byclinicians in order toaccess and displaypatient data, medicalreports, medical data,	ICIS® View is a softwareapplication used for referenceviewing of medical images andassociated reports and, as such,fulfills a key role in AgfaHealthCare's Imaging Clinical
	Imaging solution.Enables healthcare professionals,including (but not limited to)physicians, surgeons, nurses, andadministrators to receive and viewpatient images,documents and data from multipledepartments and organizations withinone multidisciplinary viewer.Viewer allows users to perform imagemanipulations (including window/level,markups, 3D visualization) andmeasurements.When images are reviewed and used asan element of diagnosis, it is theresponsibility of the trained physicianto determine if the image quality issuitable for their clinical application.	and medical images fordiagnosis from different modalities includingCR, DR, CT, MR, NM,ECG,and US.Provides wireless andportable access tomedicalimages for remotereadingor referral purposesfrom web browsersincluding usage withvalidated mobiledevices.Not intended toreplace full	Information System (ICIS).ICIS® View enables healthcareprofessionals, including (butnot limited to) physicians,surgeons, nurses, andadministrators to receive andview patient images and datafrom multiple departments andorganizations within one multi-disciplinary viewer.Users may access the productdirectly via a web-browser,select mobile devices,healthcare portal or within theElectronic Medical Record(EMR). ICIS® View allowsusers to perform basic imagemanipulations and
Enterprise ImagingXERO ViewerNEW DEVICE	Carestream VueMotion(K151774)PRIMARYPREDICATE	Agfa HealthCare'sICIS View(K143397)
images and digitized film imagesshould not be used for primary imageinterpretation. Uncompressed or non-lossy compressed "for presentation"images may be used for diagnosis orscreening on monitors that are FDAcleared for their intended use.Can optionally be configured for FullFidelity Mobile, which is intended formobile diagnostic use, review andanalysis of CR, DX, CT, MR, US, ECGimages and medical reports.Full Fidelity Mobile is notintended to replace fulldiagnostic workstations andshould only be used when there is noaccess to a workstation.Full Fidelity Mobile is not intended forthe display of mammography imagesfor diagnosis.	and should be used onlywhen there is no accessto aworkstation. Forprimaryinterpretation andreview ofmammography images,onlyuse display hardwarethat isspecifically designedfor andcleared by FDA formammography.	window/level, rotation, zoom.,and markups).ICIS® View can optionally beconfigured for Full Fidelitymode, which is intended fordiagnostic use, review andanalysis of CR, DX, CT, MR,US images and medical reports.ICIS® View Full Fidelity is notintended to replace fulldiagnostic workstations andshould only be used when thereis no access to a workstation.ICIS® View full fidelity is notintended for the display ofdigital mammography imagesfor diagnosis.

{7}------------------------------------------------

Table 1: Device Comparison Table

PERFORMANCE DATA VI.

Verification and validation testing confirmed the device meets performance, safety, usability and security requirements. No clinical trials were performed in the development of the device.

There are no applicable FDA mandated performance standards for this device. However, Agfa's in-house standard operating procedures were used for the development of the software; these procedures conform to the following standards:

ISO 13485:2003 Medical Devices Quality Management Systems ●
ISO 14971:2012 Application of Risk Management to Medical Devices ●
ISO 27001:2013 Information Security Management ●
ISO 62366:2007 Medical Devices Application of usability engineering to medical ● devices
IEC 62304:2006 Medical Device Software - Software life cycle processes
ACR/NEMA PS3.1-3.20: 2011 Digital Imaging and Communications in Medicine ● (DICOM)

Laboratory testing and software testing (for a moderate level of concern device) using equivalent test protocols as used for Medical Image Management Devices as part of verification and validation under design controls (according to 21 CFR 820.30).

{8}------------------------------------------------

No animal or clinical studies were performed in the development of the new device. No patient treatment was provided or withheld.

XERO Viewer vs. Agfa Enterprise Imaging Desktops (K142316) - Requirements & Performance of Xtend (full fidelity) diagnostic desktop viewing were evaluated (note Xtend Full Fidelity is not supported on mobile devices):

To determine substantial equivalence, diagnostic image quality was evaluated by qualified medical professionals comparing images across 2 platforms:

. Enterprise Imaging 8.0.0 Diagnostic Desktop (K142316) - using an FDA cleared diagnostic monitor
XERO Viewer Xtend full fidelity using an FDA cleared diagnostic monitor ●

A sample set of an average of 5 or 6 imaging studies per modality were evaluated. Qualified radiologists were asked to provide an overall score when comparing the diagnostic image quality in XERO Viewer to the Enterprise Imaging Diagnostic Desktop. The executed validation plan for image quality was performed on calibrated diagnostic display devices.

To evaluate ECG viewing users were asked to display ECG's in DICOM and PDF formats, change layouts, adjust waveforms and use the tools provided (zoom, measurements). Validation and non-clinical (bench) testing was performed on an iPad mobile device to ensure that the views and functionality performed consistently between desktop and a mobile platform.

Performance data including image quality evaluations by qualified radiologists are adequate to ensure equivalence to the predicate.

Summarv

Based on the performance data as documented in the above testing, XERO Viewer is found to have a safety and effectiveness profile that is similar to the predicate device.

VII. CONCLUSIONS

The device has indications for use that are consistent with those of the legally marketed predicate device. Where technological characteristics differ lab tests concluded that the device is substantially equivalent to the predicate in that it does not alter the intended therapeutic/diagnostic effect.

This 510(k) has demonstrated Substantial Equivalence as defined and understood in the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.

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).