The DIVA ZSP5812CMI with QUBYX PerfectLum is intended to be used for displaying and viewing medical images, for review and analysis by trained medical practitioners. The DIVA ZSP5812CMI can be used only in conjunction with QUBYX PerfectLum. The device can not be used in primary image diagnosis in mammography. 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 ZSP5812CMI with QUBYX PerfectLum is a 58" color display for medical viewing. It is combined with QUBYX PerfectLum and PerfectLum remote management, a userfriendly DICOM calibration and AAPM TG18 verification software suite. The software allows setting the display function to DICOM, displaying test pattern and performing acceptance and constancy tests.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the DIVA ZSP5812CMI with QUBYX PerfectLum bundle, a medical image display system. The information outlines the device's technical specifications and compares it to a predicate device, the EIZO RadiForce RX650. The core of the submission revolves around demonstrating substantial equivalence, primarily through compliance with DICOM Part 14 GSDF and AAPM TG18 standards.

Here's an analysis based on your requested information:

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

The document does not explicitly state "acceptance criteria" in a quantitative table format that shows pass/fail values. Instead, it describes general compliance with established medical display standards. However, based on the testing performed, the implicit acceptance criteria are full compliance with these standards.

Acceptance Criterion (Implicit)	Reported Device Performance (DIVA ZSP5812CMI with QUBYX PerfectLum bundle)
DICOM Part 14 GSDF Conformance	Successfully passed DICOM conformance test. Compliant.
AAPM TG18 Acceptance Test Conformance	Successfully passed AAPM TG18 acceptance test. Compliant.
Primary Category Display for Medical Image Interpretation	Can be used as a primary category display for interpretation of medical images.

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

The testing described does not involve patient data or clinical images from a "test set" in the traditional sense of AI/CADe device evaluation. Instead, the tests are primarily technical evaluations of the display's performance using software-generated patterns and measurements.

Sample size: Not applicable in the context of patient data. The "sample" consists of a single device (DIVA ZSP5812CMI) paired with the QUBYX PerfectLum software.
Data provenance: Not applicable. The "data" used for testing are standardized patterns and measurement results generated by the QUBYX PerfectLum software and an X-Rite i1 Display Pro measurement device. There is no mention of geographical origin or retrospective/prospective nature as this is a device performance test, not a clinical study.

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)

This question is not directly applicable to the type of device and testing described. The "ground truth" for display performance is defined by the objective metrics and standards set forth in DICOM Part 14 GSDF and AAPM TG18.

For the DICOM conformance test, validation is purely automated; the software compares measured values to predefined standard targets.
For the AAPM TG18 acceptance test, it involves "measurement and visual parts." While the measurement steps are automated, the "visual steps" would involve a user analyzing test patterns. However, the document does not specify that these users are "experts" (e.g., radiologists) in the sense of establishing a clinical ground truth. It's more about subjective assessment of visual quality against known patterns, guided by the software. The document does not specify the number or qualifications of these "users."

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

Not applicable. There is no multi-reader review or adjudication process described for establishing clinical ground truth or resolving discrepancies, as the testing focuses on technical compliance with display standards rather than diagnostic interpretation.

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 MRMC comparative effectiveness study was conducted or described in this submission. This device is a display monitor, not an AI/CADe system. Therefore, the concept of "human readers improving with AI vs. without AI assistance" is not relevant to this 510(k) summary.

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

A standalone performance test was done, but it pertains to the technical performance of the display device and its calibration software, not a diagnostic algorithm. The DICOM conformance tests and the measurement portions of the AAPM TG18 tests are essentially standalone algorithms (within the PerfectLum software) verifying the display's adherence to standards without human intervention in the measurement and comparison phases. The "visual parts" of the AAPM test involve a human, but not as an "algorithm."

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

The "ground truth" for this submission is adherence to established technical standards and specifications:

DICOM Part 14 GSDF (Grayscale Standard Display Function): This standard defines the photometric response curve for medical image displays. The ground truth here is the mathematically defined curve.
AAPM TG18 (American Association of Physicists in Medicine Task Group 18) standards: These provide guidelines and test patterns for evaluating medical display performance. The ground truth consists of the specified ideal characteristics (e.g., luminance, uniformity, spatial resolution) and visual criteria for the test patterns.

8. The sample size for the training set

Not applicable. This device is a display monitor and its calibration software, not an AI/machine learning algorithm that requires a "training set" of data.

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

Not applicable, as there is no training set for this device.

Summary

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

November 17, 2015

Qubyx Ltd. % Mr. Marc Leppla Director, CTO 80, rue Marechal Joffre Nice, 06000 FRANCE

Re: K152847

Trade/Device Name: DIVA ZSP5812CMI with OUBYX PerfectLum Bundle Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: September 16, 2015 Received: September 29, 2015

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.

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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 Oels

Robert 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)

K152847

Device Name

DIVA ZSP5812CMI with QUBYX PerfectLum bundle

Indications for Use (Describe)

The DIVA ZSP5812CMI with QUBYX PerfectLum is intended to be used for displaying and viewing medical images, for review and analysis by trained medical practitioners.

The DIVA ZSP5812CMI can be used only in conjunction with QUBYX PerfectLum.

The device can not be used in primary image diagnosis in mammography.

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)

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510(K) Summary as required by 807.92

Company Identification QUBYX Limited 80, rue Marechal Joffre 06000 Nice, France Tel: +33 4 97 03 23 00
Official Correspondent Mr. Marc Leppla President and CTO (Chief Technical Officer) leppla@qubyx.com
Date of Submission 09/16/2015
Device Trade name DIVA ZSP5812CMI with QUBYX PerfectLum bundle
Common/Usual Name Image display system, Color LCD Monitor, image monitor/display
Classification Number Medical displays classified in Class II per 21 CFR 892.2050
Predicate device 1 Name: EIZO RadiForce RX650 Manufacturer: EIZO Corporation 510(k) number: K134002

8. Device description

The DIVA ZSP5812CMI with QUBYX PerfectLum is a 58" color display for medical viewing.

It is combined with QUBYX PerfectLum and PerfectLum remote management, a userfriendly DICOM calibration and AAPM TG18 verification software suite. The software allows setting the display function to DICOM, displaying test pattern and performing acceptance and constancy tests.

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9. Indications for use

	Subject Device	Predicate device
	DIVA ZSP5812CMI withPerfectLum	EIZO RadiForce RX650
510(k) number:		K134002
Panel Type	MVA	IPS
Panel size	58" viewable	30" viewable
Native Resolution	3840 x 2160	3280×2048 0.197 x
Pixel Pitch	0.334 x 0.334 mm	0.197 mm
Brightness (typical)Viewing Angle(typical)	400 cd/m2	400 cd/m2
	178° Vert., 178° Hor.	176° Vert., 176° Hor.
Displayable Colors	1G colors (8-bit+FRC)	10-bit colors (DisplayPort) :1.07 billion (maximum) colors;8-bit colors: 16.77 million
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	310W	225W
Certification andCompliance	cTÜVus (UL 60601-1, CAN/CSA C22.2No.60601-1), CB (IEC60601-1),TUV/RH (EN 60601- 1),FCC, CE, RoHS, WEEE	FCC Class B certified, C-Tick,ICES-003 Class B, CCC, UL 60601-1,RoHS, WEEE, GOST-R, DICOM Part14, FDA 510k, EN 60601-1, IEC60601-1, VCCI Class B, CSA C22.2No. 60601-1, China RoHS
Indications for Use	The DIVA ZSP5812CMI withQUBYX PerfectLum is intended tobe used for displaying andviewing medical images, forreview and analysis by trainedmedical practitioners.	The EIZO RadiForce RX650 isintended to be used in displaying andviewing digital images for review andanalysis by trained medicalpractitioners.It does not support the display ofmammographyimages for diagnosis.
	The DIVA ZSP5812CMI can beused only in conjunction withQUBYX PerfectLum. The devicecan not be used in primary imagediagnosis in mammography.The device can not be used for alife-support system. The device

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Conclusion:

The comparison table shows that the subject device (DIVA ZSP512CMI with PerfectLum) has the same intended use as the predicate. Although the devices have some different technological characteristics, these differences do not make the sub ect 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 PerfectLumsoftware 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 device, so the two 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.

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, except for predicate device it is not specified that it will not contact with the patient.

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).