The DIVA ZSP2105CMI with QUBYX PerfectLum is intended to be used for displaying and viewing medical images, including those of mammography, for review, analysis and diagnosis by trained medical practitioners.

The DIVA ZSP2105CMI can be used only in conjunction with QUBYX PerfectLum.

The device can not be used for a life-support system.

The device does not contact with the patient.

The device is intended for prescription use.

Device Description

The DIVA ZSP2105CMI with QUBYX PerfectLum is a 21.3" monochrome display for medical viewing. It can be used for diagnostic viewing or normal reviewing purpose of medical images like computed tomography images, digitalized x-ray images, etc. It is combined with QUBYX PerfectLum and PerfectLum Remote Management, a user-friendly DICOM calibration and AAPM TG18 verification software suite. The software allows setting the display function to DICOM GSDF, displaying test patterns and performing acceptance and constancy tests according to AAPM TG18.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the DIVA ZSP2105CMI with QUBYX PerfectLum bundle:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the device's compliance with two key standards rather than setting specific numerical acceptance criteria for a clinical study with patients. The performance is reported as meeting these standards.

Acceptance Criterion	Reported Device Performance
DICOM Part 14 GSDF Conformance	The display device successfully passed DICOM conformance test and is compliant with DICOM Part 14 GSDF standard.
AAPM TG18 Acceptance Test	The display device successfully passed AAPM TG18 acceptance test and is compliant with AAPM TG18 standard, enabling its use as a primary category display for medical image interpretation.

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

Sample Size: The document does not specify a "sample size" in the context of patients or medical images. The testing described focuses on a single instance of the DIVA ZSP2105CMI with QUBYX PerfectLum device.
Data Provenance: Not applicable in the traditional sense of patient data. The tests were performed using software-generated patterns and measurements on the device itself. The tests were performed by QUBYX and verified by the University of Arizona.

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

Number of Experts: The document does not mention the use of experts to establish "ground truth" for a test set of medical images. The ground truth for the technical performance was established by measurement devices and software comparing device output to defined standards (DICOM, AAPM).
Qualifications of Experts: Not applicable. For the visual steps of the AAPM TG18 test, it mentions "the user analyzed test patterns," but it doesn't specify if this user was a medical expert or their qualifications.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable. The "test set" in this context refers to the device's technical specifications and adherence to standards, which are evaluated by measurement tools and software against predefined targets, not by a panel of human adjudicators.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

MRMC Study: No, an MRMC comparative effectiveness study was not done. The device is a medical display, not an AI algorithm designed to assist human readers directly.
Effect Size: Not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Standalone Performance: Not applicable. The device itself is a display monitor and calibration software. Its performance is evaluated on its ability to accurately display images according to standards, not as an AI algorithm that produces an output on its own.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):

Type of Ground Truth: The ground truth used was conformance to established technical standards:
- DICOM Part 14 GSDF Standard: For grayscale display function.
- AAPM TG18 Standard: For diagnostic display quality and acceptance testing.
  These standards define objective criteria for luminance, contrast, uniformity, and resolution.

8. The Sample Size for the Training Set:

Sample Size for Training Set: Not applicable. This device is not an AI algorithm that requires a training set of data.

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

Ground Truth for Training Set: Not applicable.

Summary

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is placed to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the symbol.

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

February 25, 2016

The Linden Group Corp. % Mr. Marc Leppla Director, CTO Oubyx Ltd. 80, rue Marechal Joffre Nice, 06000 FRANCE

Re: K160328

Trade/Device Name: DIVA ZSP2105CMI with QUBYX PerfectLum bundle Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY, Dated: January 22, 2016 Received: February 5, 2016

Dear Mr. Leppla:

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.

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

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 yours,

Michael D.'Hara

For

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) K160328

Device Name DIVA ZSP2105CMI with QUBYX PerfectLum bundle

Indications for Use (Describe)

The DIVA ZSP2105CMI with QUBYX PerfectLum is intended to be used for displaying and viewing medical images,

including those of mammography, for review, analysis and diagnosis by trained medical practitioners.

The DIVA ZSP2105CMI can be used only in conjunction with QUBYX PerfectLum.

The device can not be used for a life-support system.

The device does not contact with the patient.

The device is intended for prescription use.

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)

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 as required by 807.92

Company Identification

The Linden Group Corp. 2b Wing Dr Cedar Knolls NJ 079271020 ાટ

Official Correspondent Mr. Marc Leppla (President and CTO of QUBYX Ltd.) Contact details: email: leppla@qubyx.com Tel: +33 497032300
Date of Submission 22/01/2016
Device Trade name DIVA ZSP2105CMI with QUBYX PerfectLum bundle
Common/Usual Name Image display system, Monochrome LCD Monitor, image monitor/display
Classification Number Medical displays classified in Class II per 21 CFR 892.2050
Predicate device Name: EIZO RadiForce GX540 Manufacturer: EIZO Corporation 510(k) number: K151883

Description of the device:

Indications for use:

The DIVA ZSP2105CMI with QUBYX PerfectLum is intended to be used for displaying and viewing of digital images, including those of mammography, for review, analysis and diagnosis by trained medical practitioners.

The DIVA ZSP2105CMI must only be used in conjunction with QUBYX PerfectLum. The device does not contact with the patient and can not be used for a life-support system. The device is intended for prescription use.

Device comparison table:

	Subject Device DIVAZSP2105CMI withPerfectLum	Predicate device EIZORadiForce GX540
510(k) number	K160328	K151883
Panel Type	IPS	IPS
Panel size	21.3"	21.3"
Native Resolution	2560 x 2048	2560 x 2048
Pixel Pitch	0.165mm × 0.165mm	0.165mm × 0.165mm
Brightness (typical)	1200 cd/m2	1200 cd/m2
Viewing Angle(typical)	170° Vert., 170° Hor.	176° Vert., 176° Hor.
Displayable Colors	1024 grayscale (10-bit)	10-bit (DisplayPort): 1,024from a palette of 16,369tones8-bit: 256 from a palette of16,369 tones
DICOM calibrationsoftware and AAPMverification software	bundled	bundled
Backlight	LED	LED
DICOM precalibrated	YES	YES
Power Requirements	AC 100 to 240 V,50 / 60 Hz	AC 100 - 120 V,200 - 240 V: 50 / 60 Hz
Power Consumption	100W	108W
Certification andCompliance	CE (Medical Device Directive),93/42/EEC, EN60601-1,EN60601-2, FCC Class B,cTUVus (UL 60601-1, CAN/CSAC22.2 No.60601-1),CNS14336-1, CNS13438),VCCI by ITE, Apr.2010, Class B(Requlation of VCCI V-2 andVCCI-3 and VCCI V-4), RoHS,WEEE	CE (Medical Device Directive),EN60601-1,UL60601-1, CSA C22.2 No.601-1,IEC60601-1,VCCI-B, FCC-B, CanadianICES-003-B, C-tick,RoHS, China RoHS, WEEE,CCC, GOST-R
Indications for Use	The DIVA ZSP2105CMI withQUBYX PerfectLum is intendedto be used for displaying andviewing medical images,including those ofmammography,	The EIZO RadiForce GX540 isintendedto be used in displaying andviewingdigital images, includingstandard and
	for review, analysis anddiagnosis by trained medicalpractitioners. The DIVAZSP2105CMI can be used onlyin conjunction withQUBYX PerfectLum.The device can not be used fora life-support system. Thedevice does not contact withthe patient.	multi-framedigital mammography, forreview,analysis and diagnosis bytrainedmedical practitioners. It isspeciallydesigned forbreast tomosynthesisapplications.

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

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

The comparison table shows that the subject device (DIVA ZSP2105CMI with PerfectLum) has the same intended use as the predicate one.

Although the devices have some different technological characteristics, these differences do not make the subject device less safe and reliable, so the subject device fits for diagnostic use as the predicate device does.

Both devices are compliant with DICOM Part 14 GSDF and AAPM TG18 standards, which is tested and verified by University of Arizona. To verify DICOM and AAPM compliance for the subject device, AAPM acceptance test and DICOM conformance test were also performed by QUBYX.

Details of testing:

To verify DICOM conformance, a DICOM conformance test was performed,

using QUBYX PerfectLum software and an X-Rite i1 Display Pro measurement device. The test procedure was generated by the software in accordance with the requirements of the DICOM standard. It consisted of measurement steps, where the meter measured display's characteristics and the software recorded them. Then the software analyzed the results in comparison with target values, defined by DICOM standard, and generated the report, stating that the display is DICOM-conformant. The display device has successfully passed DICOM conformance test, so it is compliant with DICOM Part 14 GSDF standard. So is the predicate devices are substantially equivalent in this regard.

To verify AAPM TG18 conformance, an acceptance test was performed, using QUBYX PerfectLum software and an X-Rite i1 Display Pro measurement device. The test procedure was generated by the software in accordance with the requirements of the AAPM TG18 standard and consisted of measurement and visual parts.

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

During the measurement steps, the meter measured display's characteristics and the software recorded them. During the visual steps, the user analyzed test patterns, generated by the software in accordance with AAPM standard. The software recorded the user's answers. Then the software analyzed the results in comparison with target values, defined by AAPM standard, and generated the report, stating that the display passes AAPM TG18 acceptance test.

The display device has successfully passed AAPM TG18 acceptance test, so it is compliant with AAPM TG18 standard and can be used as a primary category display for interpretation of medical images. The same is true for the predicate device, so the two devices are substantially equivalent in this regard.

Both devices have the same indications for use.

We can conclude that the new and predicate devices are substantially equivalent in terms of performance, indications for use, and principles of operation.

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).