(258 days)
The DELL UltraSharp U3011 with QUBYX PerfectLum is intended to be used in displaying and viewing of digital images, for review and analysis by trained medical practitioners.
The DELL UltraSharp U3011 must only be used in conjunction with QUBYX PerfectLum 3.0
These devices must not be used in primary image diagnosis in mammography.
The device can not be used for a life-support system.
The DELL UltraSharp U3011 with QUBYX PerfectLum is a 30" color display for medical viewing. It provides 4 mega pixel (2560x1600) resolution with a adjustable Look Up Table and a 10 bit Panel.
It is combined with QUBYX PerfectLum 3.0 and PerfectLum remote QA, a user-friendly DICOM calibration and AAPM TG18 verification software suite. The software allows to set the display function to DICOM, display testpattern and perform acceptance and constancy tests.
The provided text is a 510(k) summary for the DELL UltraSharp U3011 with QUBYX PerfectLum bundle. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with specific acceptance criteria and detailed results.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC effectiveness studies cannot be extracted directly from this document. The document describes a comparison, not an independent performance study against set criteria as would typically be seen for a new diagnostic algorithm or device requiring such validation.
The primary method used to "prove" the device meets acceptance criteria in this context is through substantial equivalence to an existing legally marketed device (the predicate device). The acceptance criteria, in this case, are implicitly that the new device performs at least as well as, or is sufficiently similar to, the predicate device in its intended use and technical specifications.
Here's a breakdown of what can be extracted and explanations for what cannot:
1. Table of acceptance criteria and the reported device performance:
As explained above, explicit acceptance criteria in the sense of performance metrics (sensitivity, specificity, accuracy, etc.) are not provided. The "performance" is a comparison to a predicate device.
| Characteristic | DELL U3011 with PerfectLum version 3 (New Device) | Predicate device NEC LCD3090WQXI (K083916) | Implicit Acceptance/Comparison |
|---|---|---|---|
| Panel Type | IPS | IPS | Equivalent |
| Panel size | 30" viewable | 29.8" viewable | Similar |
| Native Resolution | 2560 x 1600 | 2560 x 1600 | Equivalent |
| Pixel Pitch | 0.25 mm | 0.25 mm | Equivalent |
| Brightness (typical) | 370 cd/m2 | 350 cd/m2 | New device is slightly better |
| Contrast Ratio (typical) | 1000:1 | 1000:1 | Equivalent |
| Viewing Angle (typical) | 178° Vert., 178° Hor. | 178° Vert., 178° Hor. | Equivalent |
| Displayable Colors | 1.07 billion colors | 16.7 million | New device is significantly better |
| DICOM calibration software and AAPM verification software | bundled | optional | New device offers as standard, old as option |
| Panel bit depth | 10 bit | 8 bit | New device is better |
| Color Gamut | 117% | 102% | New device is better |
The "acceptance criteria" here are that the new device should not be worse than the predicate in critical areas and can be better. The conclusion states: "The new and predicate device are substantially equivalent in the areas of technical characteristics, general function, application and indented use."
2. Sample size used for the test set and the data provenance:
- Not applicable/Not provided. This document describes a technical comparison of display specifications and software features, not a diagnostic performance study using a test set of medical images.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. No clinical ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided.
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:
- Not applicable/Not provided. This is a medical display, not an AI-assisted diagnostic tool requiring MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable/Not provided. This is a medical display, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable/Not provided. The "ground truth" for this submission would be the published specifications and performance of the predicate device and the measured specifications of the new device.
8. The sample size for the training set:
- Not applicable/Not provided. This is a hardware/software bundle, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable/Not provided.
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JAN 3 0 2012
510(K) Summary of Safety and Effectiveness
as required by 807.92
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Company Identification QUBYX Limited 80, rue Marechal Joffre 06000 Nice, France Tel: +33 4 97 03 23 00
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Official Correspondent Mr Marc Leppla President and CTO (Chief Technical Officer) leppla@gubyx.com
FDA CDRH I WK
MAY 1 7 2011
trakasina
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Date of Submission May 05, 2011
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Device Trade name DELL UltraSharp U3011 with QUBYX PerfectLum bundle
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Common/Usual Name Image display system, Color LCD Monitor, image monitor/display
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Classification Number Medical displays classified in Class II per 21 CFR 892.2050
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Predicate device Name: LCD3090WQXI Manufacturer: NEC Display Solutions Ltd 510(k) number: K083916
IC29
1
- Device description
The DELL UltraSharp U3011 with QUBYX PerfectLum is a 30" color display for medical viewing. It provides 4 mega pixel (2560x1600) resolution with a adjustable Look Up Table and a 10 bit Panel.
It is combined with QUBYX PerfectLum 3.0 and PerfectLum remote QA, a user-friendly DICOM calibration and AAPM TG18 verification software suite. The software allows to set the display function to DICOM, display testpattern and perform acceptance and constancy tests.
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9. Intended use
The DELL UltraSharp U3011 with QUBYX PerfectLum is intended to be used in displaying and viewing of digital images, for review and analysis by trained medical practitioners.
The DELL UltraSharp U3011 must only be used in conjunction with QUBYX PerfectLum 3.0
These devices must not be used in primary image diagnosis in mammography.
The device can not be used for a life-support system.
10. Conclusion
Compared to the predicate device, the U3011 uses a 10 bit instead of a 8 bit panel. The U3011 offer a typical brightness of 370 cd/m2 and the NEC 3090WQXi of 350 cd/m2. The Color Gamut is 102% for the NEC 3090WQXi and 117% for the DELL U3011.
The new and predicate device are substantially equivalent in the areas of technical characteristics, general function, application and indented use.
| DELL U3011 withPerfectLum version 3 | Predicate deviceNEC LCD3090WQXI510(k) number: K083916 | |
|---|---|---|
| Panel Type | IPS | IPS |
| Panel size | 30" viewable | 29.8" viewable |
| Native Resolution | 2560 x 1600 | 2560 x 1600 |
| Pixel Pitch | 0.25 mm | 0.25 mm |
| Brightness (typical) | 370 cd/m2 | 350 cd/m2 |
| Contrast Ratio (typical) | 1000:1 | 1000:1 |
| Viewing Angle (typical) | 178° Vert., 178° Hor. | 178° Vert., 178° Hor. |
| Displayable Colors | 1.07 billion colors | 16.7 million |
| DICOM calibration softwareand AAPM verificationsoftware | bundled | optional |
Comparison table
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the seal is an abstract symbol that resembles an eagle or a stylized human figure with outstretched arms.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 ·Silver Spring, MD 20993-0002
JAN 3 0 2012
Dr. Marc Leppla President and CTO QUBYX Limited 80 rue Marechal Joffre 06000 NICE FRANCE
Re: K111385
Trade/Device Name: qubyx's DELL UltraSharp U3011 with QUBYX PerfectLum Bundle Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 13, 2011 Received: December 13, 2011
Dear Dr. 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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours.
Mary S Patel
Mary S. Pastel. Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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.K 111 385
Indications for Use Form
510(k) Number: K111385
Device Name: qubyx's DELL UltraSharp U3011 with QUBYX PerfectLum Bundle
Indications for Use: The DELL UltraSharp U3011 with QUBYX PerfectLum is intended to be used in displaying and viewing of digital images, for review and analysis by trained medical practitioners.
The DELL UltraSharp U3011 must only be used in conjunction with QUBYX PerfectLum 3.0
These devices must not be used in primary image diagnosis in mammography.
The device can not be used for a life-support system.
Prescription Use No (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use Yes (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mary Slatel
Division Sign-Off Office of In Vitro Diagnostic Device
Evaluation and Safety
510(k) K111385
Page 1 of 1
§ 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).