The DELL U3014 with QUBYX PerfectLum is intended to be used for displaying and viewing of digital images, for review and analysis by trained medical practitioners. The DELL U3014 must only be used in conjunction with QUBYX PerfectLum. The device must not be used in primary image diagnosis in mammography. The device can not be used for a life-support system and does not contact with the patient.

Device Description

The DELL U3014 with QUBYX PerfectLum is a 30" color display for medical viewing. It provides 2560x1600 resolution with an adjustable Look Up Table and a 10 bit panel. 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 acceptance criteria and study proving the device meets those criteria are detailed below. It's important to note that this document describes a medical display system, not an AI algorithm for diagnostic interpretation. Therefore, some standard questions related to AI studies (like MRMC, training set details, or deep learning specific ground truth) are not applicable in this context.

1. Table of Acceptance Criteria and Reported Device Performance

Criterion	Acceptance Standard	Reported Device Performance
DICOM Conformance	DICOM Part 14 GSDF standard	Successfully passed DICOM conformance test; compliant with DICOM Part 14 GSDF standard.
AAPM TG18 Conformance	AAPM TG18 standard acceptance test requirements	Successfully passed AAPM TG18 acceptance test; compliant with AAPM TG18 standard.
Intended Use	Displaying and viewing medical images for review and analysis by trained medical practitioners. Not for primary image diagnosis in mammography. Not a life-support system. No patient contact.	Meets all stated indications for use.
Technical Characteristics (key)	Similar to predicate devices (DELL U3011, NEC MD301C4)	Substantially equivalent to predicate devices, with minor differences (e.g., backlight type, slight luminance variation).
Software Bundle	Must be used in conjunction with QUBYX PerfectLum	Bundled with QUBYX PerfectLum for calibration and verification.

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

The "test set" in this context refers to the physical device undergoing conformance testing, not a dataset of medical images.

Sample Size for Test Set: One unit of the DELL U3014 with QUBYX PerfectLum bundle.
Data Provenance: The device performance data was generated through tests conducted by QUBYX and verified by the University of Arizona. This is a prospective evaluation of a specific hardware and software combination.

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

This question is not directly applicable. The "ground truth" for a medical display system's performance is objective compliance with technical standards (DICOM Part 14 GSDF and AAPM TG18). These standards define measurable characteristics and visual patterns for evaluation.

The tests were performed using instrumentation (X-Rite i1 Display Pro measurement device) and software (QUBYX PerfectLum) according to the specified standards.
One "user" was involved in the visual steps of the AAPM TG18 test. While not explicitly stated to be an "expert" in the same way a radiologist diagnoses an image, this user's role was to assess test patterns as per the AAPM standard, implying knowledge of what to look for based on documented criteria.
The overall compliance was verified by the University of Arizona, implying expert oversight in the validation process, though specific qualifications of individuals involved are not provided in this summary.

4. Adjudication Method for the Test Set

Not directly applicable in the typical sense of agreement on diagnostic findings. The adjudication of the device's technical performance was based on:

Objective Measurement: The X-Rite i1 Display Pro measurement device performed objective measurements of display characteristics.
Software Analysis: The QUBYX PerfectLum software analyzed these measurements against target values defined by DICOM and AAPM standards.
User Input (for visual tests): For visual steps of the AAPM TG18 test, a user's answers were recorded and analyzed by the software against the standard's criteria.
Verification: The results of these tests were verified by the University of Arizona. There is no mention of a multi-reader adjudication method for discrepancies, as the tests themselves are designed to be objective or based on clearly defined visual criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not performed. This type of study is relevant for evaluating the impact of an AI algorithm on human reader performance for diagnostic tasks using medical images. This submission is for a medical display system, where regulatory clearance is based on its technical compliance with established standards for image presentation, not its impact on diagnostic accuracy through reader studies.

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

This question is not applicable. The device is a display system, not a diagnostic algorithm. Its "standalone performance" refers to its ability to meet display standards, which was evaluated through technical tests (DICOM and AAPM compliance) as described.

7. The Type of Ground Truth Used

The ground truth used for evaluating the display system's performance was:

Established Industry Standards: DICOM Part 14 Grayscale Standard Display Function (GSDF) and AAPM TG18 display quality control guidelines.
These standards define objective requirements for luminance response, uniformity, resolution, and other visual characteristics essential for medical image display.

8. The Sample Size for the Training Set

This question is not applicable. The device is a medical display system, not an AI algorithm that requires a training set of data.

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

This question is not applicable for the reasons stated above.

Summary

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K131601
6.1
Page 1 of 5

JUL 0 7 2014

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@gubyx.com
Date of Submission May 21. 2013
Device Trade name DELL U3014 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: UltraSharp U3011 Manufacturer: DELL Inc. 510(k) number: K111385

Predicate device 2 Name: MD301 C4 Manufacturer: NEC Display Solutions Ltd. 510(k) number: K111237

Device description

The DELL U3014 with QUBYX PerfectLum is a 30" color display for medical viewing. It provides 2560x1600 resolution with an adjustable Look Up Table and a 10 bit panel.

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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Intended use

The DELL U3014 with QUBYX PerfectLum is intended to be used for displaying and viewing of digital images, for review and analysis by trained medical practitioners.

The DELL U3014 must only be used in conjunction with QUBYX PerfectLum. The

device must not be used in primary image diagnosis in mammography. The device can not be used for a life-support system and does not contact with the patient.

Comparison table - predicate device 1

	DELL U3014 withPerfectLum	Predicate device DELLU3011 with PerfectLum510(k) number: K111385
Panel Type	IPS	IPS
Panel size	30" viewable	30" viewable
Native Resolution	2560 x 1600	2560 x 1600
Aspect Ratio	16:10	16:10
Pixel Pitch	0.25 mm	0.25 mm
Brightness (typical)	350 cd/m2	370 cd/m2
Contrast Ratio (typical)	1:1000	1:1000
Viewing Angle (typical)	178° Vert., 178° Hor.	178° Vert., 178° Hor.
Displayable Colors	1.07 billion colors	1.07 billion colors
Backlight	RGB LED	CCFL
DICOM calibration andAAPM verification software	bundled	bundled
Indications for Use	The DELL U3014 withQUBYX PerfectLum isintended to be used fordisplaying and viewingmedical images, forreview and analysis bytrained medicalpractitioners. The DELLU3014 can be used onlyin conjunction withQUBYX PerfectLum.The device can not beused in primary imagediagnosis inmammography.The device can not beused for a life-supportsystem. The device doesnot contact with thepatient.	The DELL U3011 withQUBYXPerfectLum is intended tobe used for displaying andviewing medical images,for review and analysis bytrained medicalpractitioners.The DELL U3011 can beused only in conjunctionwith QUBYX PerfectLum.The device can not beused in primary imagediagnosis inmammography.The device can not beused for a life-supportsystem.

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Conclusion

DELL U3014 is the direct successor of the DELL U3011 model in the product line of UltraSharp displays, so the DELL U3014 with PerfectLum has exactly the same technical characteristics that predicate device 1 (DELL U3011 with PerfectLum) except maximum luminance (maximum luminance of the U3011 model is 370 cd/m2, while maximum luminance of the U3014 display is 350 cd/m2) and backlight type.

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.

The new and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application and indented use

	DELL U3014 with PerfectLum	Predicate device NECMD301C4,510(k)number: K111237
Panel Type	IPS	IPS
Panel size	30" viewable	29.8" viewable
Native Resolution	2560 x 1600	2560 x 1600

11. Comparison table - predicate device 2

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Aspect Ratio	16:10	16:10
Pixel Pitch	0.25 mm	0.25 mm
Brightness (typical)	350 cd/m2	350 cd/m2
Contrast Ratio (typical)	1:1000	1:1000
Viewing Angle (typical)	178° Vert., 178° Hor.	178° Vert., 178° Hor.
Displayable Colors	1.07 billion colors	1.07 billion colors
Backlight	RGB LED	LED
DICOM calibration andAAPM verification software	bundled	no software, pre-calibrated to DICOM,compliant with AAPMTG 18
Indications for Use	The DELL U3014 withQUBYX PerfectLum isintended to be used fordisplaying and viewingmedical images, for reviewand analysis by trainedmedical practitioners.The DELL U3014 can beused only in conjunctionwith QUBYX PerfectLum.The device can not beused in primary imagediagnosis inmammography.The device can not be usedfor a life-support system.The device does notcontact with the patient.	MD3OIC4 is intended tobe used for displayingand viewing of digitalimages for diagnosis bytrained physicians.Caution: MD3OIC4cannot be used for alife-support system.This unit is designedas component of afinal system which iscompliance toIEC60601-1-1requirements. MD3OIC4 must not be usedin digitalmammography.

Conclusion

DELL U3014 with PerfectLum and NEC MD301C4 have substantially equivalent technical characteristics, such as resolution, luminance, pixel pitch, viewing angle. The diagonal size of the NEC MD301C4 monitor is 0.2" smaller than that of the subject device.

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

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.

6.4

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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.

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.

Both devices are intended to be used for displaying of digital images for diagnosis by trained physicians; both cannot be used for a life-support system and must not be used in digital mammography. The predicate device is designed as component of a final system which is compliant with IEC60601-1-1 requirements, while the indications for use for the new device do not specify what final system it will be used in. The DELL U3014 with PerfectLum is not intended for use in direct contact with the patient, while indications for use of the predicate device do not specify that.

We believe that these differences do not effect the safety and effectiveness of the DELL U3014 with PerfectLum to be substantially equivalent to the predicate device. The new and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application and indented use.

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three curved lines that resemble a human figure.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

July 7, 2014

QUBYX Limited % Ms. Alice Kotlyarenko Marketing and Sales Assistant 80, rue Marechal Joffre 06000 Nice FRANCE

Re: K131601

Trade/Device Name: Dell U3014 with QUBYX PerfectLum Bundle Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: June 6, 2013 Received: June 17, 2014

Dear Ms. Kotlyarenko:

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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Page 2-Ms. Kotlyarenko

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Michael D. O'Hara

For

Janine M. Morris 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 Form

510(k) Number (if known): K131601

Device Name: Dell U3014 with QUBYX PerfectLum bundle

Indications for Use: The DELL U3014 with QUBYX PerfectLum is intended to be used for displaying and viewing medical images, for review and analysis by trained medical practitioners. The DELL U3014 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.

AND/OR Over-The-Counter Use _ Prescription Use No (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Michael D. O'Hara

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

K131601 510(k)________________________________________________________________________________________________________________________________________________________________________

Page 1 of __ 1

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).