standards and recommendations forcolor medical displays · summit on color in medical imaging 2013...

Summit on Color in Medical Imaging 2013

Standards and Recommendations for Color

Medical Displays

A Review of Current Activities at AAPM and IEC

Aldo Badano

Division of Imaging and Applied MathematicsOffice of Science and Engineering Laboratories

Center for Devices and Radiological HealthFood and Drug Administration

DISCLOSURES

Equipment loans: RMD, EIZO/NANAO, PLANAR,CHIMEI-O.

Collaborative R&D agreements (CRADAs) withFIMI/BARCO and VARIAN.

Mention of commercial products herein is not to beconstrued as either an actual or implied endorsement ofsuch products by DHHS.

1995 2015• •

Technologies

Standards and recommendations

FDA events

1995 2015• •

Technologies


FDA events

•1996 5MP CRT

1995 2015• •

Technologies


FDA events

•1996 5MP CRT

•1999 5MP LCD

1995 2015• •

Technologies


FDA events

•1996 5MP CRT

•1999 5MP LCD

•2000 Dynamic LCD

1995 2015• •

Technologies


FDA events

•1996 5MP CRT

•1999 5MP LCD

•2000 Dynamic LCD

•2001 9MP LCD

1995 2015• •

Technologies


FDA events

•1996 5MP CRT

•1999 5MP LCD

•2000 Dynamic LCD

•2001 9MP LCD

•2003 Tiled

1995 2015• •

Technologies


FDA events

•1996 5MP CRT

•1999 5MP LCD

•2000 Dynamic LCD

•2001 9MP LCD

•2003 Tiled

•2005 Projection

1995 2015• •

Technologies


FDA events

•1996 5MP CRT

•1999 5MP LCD

•2000 Dynamic LCD

•2001 9MP LCD

•2003 Tiled

•2005 Projection

•2006 Portables

1995 2015• •

Technologies


FDA events

•1996 5MP CRT

•1999 5MP LCD

•2000 Dynamic LCD

•2001 9MP LCD

•2003 Tiled

•2005 Projection

•2006 Portables

•2006 Flexibles

1995 2015• •

Technologies


FDA events

•1996 5MP CRT

•1999 5MP LCD

•2000 Dynamic LCD

•2001 9MP LCD

•2003 Tiled

•2005 Projection

•2006 Portables

•2006 Flexibles

•2007 8MP+

1995 2015• •

Technologies


FDA events

•1996 5MP CRT

•1999 5MP LCD

•2000 Dynamic LCD

•2001 9MP LCD

•2003 Tiled

•2005 Projection

•2006 Portables

•2006 Flexibles

•2007 8MP+

•2010 Retina

1995 2015• •

Technologies


FDA events

•1996 5MP CRT

•1999 5MP LCD

•2000 Dynamic LCD

•2001 9MP LCD

•2003 Tiled

•2005 Projection

•2006 Portables

•2006 Flexibles

•2007 8MP+

•2010 Retina

•2011 Stereo

1995 2015• •

Technologies


FDA events

•1996 5MP CRT

•1999 5MP LCD

•2000 Dynamic LCD

•2001 9MP LCD

•2003 Tiled

•2005 Projection

•2006 Portables

•2006 Flexibles

•2007 8MP+

•2010 Retina

•2011 Stereo

•2007 TG18

Assessment of display performance for medical imaging systems:Executive summary of AAPM TG18 reportChairman:

Ehsan Sameia!

Duke Advanced Imaging Laboratories, Departments of Radiology, Physics, and Biomedical Engineering,Duke University, DUMC 3302, Durham, North Carolina 27710

TG18 Members:

Aldo BadanoFDA, CDRH

Dev ChakrabortyUniversity of Pennsylvania (currently with University of Pittsburgh)

Ken ComptonClinton Electronics (currently with National Display Systems)

Craig CorneliusEastman Kodak Company (currently a consultant)

Kevin CorriganLoyola University

Michael J. FlynnHenry Ford Health system

Bradley HemmingerUniversity of North Carolina, Chapel Hill

Nick HangiandreouMayo Clinic, Rochester

Jeffrey JohnsonSarnoff Corp, NIDL (currently with Siemens Corporate Research)

Donna M. Moxley-StevensUniversity of Texas, Houston, M.D. Anderson Cancer Center

William PavlicekMayo Clinic, Scottsdale

Hans RoehrigUniversity of Arizona

Lois RutzGammex/RMI

Ehsan SameiDuke University Medical Center

Jeffrey ShepardUniversity of Texas, Houston, M.D. Anderson Cancer Center

Robert A. UzenoffFujifilm Medical Systems USA

Jihong WangUniversity of Texas, Southwestern Medical Center (currently with University of Texas, Houston)

Charles E. WillisBaylor University, Houston, Texas Children’s Hospital (currently with University of Texas, Houston)

sReceived 27 August 2004; revised 4 December 2004; accepted for publication 23 December 2004;published 31 March 2005d

1205 1205Med. Phys. 32 „4…, April 2005 0094-2405/2005/32 „4…/1205/21/$22.50 © 2005 Am. Assoc. Phys. Med.

1995 2015• •

Technologies


FDA events

•1996 5MP CRT

•1999 5MP LCD

•2000 Dynamic LCD

•2001 9MP LCD

•2003 Tiled

•2005 Projection

•2006 Portables

•2006 Flexibles

•2007 8MP+

•2010 Retina

•2011 Stereo

•2007 TG18


Ehsan Sameia!


TG18 Members:













Lois RutzGammex/RMI








•2009 IEC Intl Std

IEC 62563-1Edition 1.0 2009-12

INTERNATIONAL STANDARD NORME INTERNATIONALE

Medical electrical equipment – Medical image display systems – Part 1: Evaluation methods Appareils électromédicaux – Systèmes d’imagerie médicale – Partie 1: Méthodes d’évaluation

IEC

625

63-1

:200

9

®

colourinside

Copyright International Electrotechnical Commission Provided by IHS under license with IEC Licensee=Food & Drug Administration /8853100001, User=badano, aldo

Not for Resale, 12/17/2009 13:34:03 MSTNo reproduction or networking permitted without license from IHS

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1995 2015• •

Technologies


FDA events

•1996 5MP CRT

•1999 5MP LCD

•2000 Dynamic LCD

•2001 9MP LCD

•2003 Tiled

•2005 Projection

•2006 Portables

•2006 Flexibles

•2007 8MP+

•2010 Retina

•2011 Stereo

•2007 TG18


Ehsan Sameia!


TG18 Members:













Lois RutzGammex/RMI









IEC 62563-1Edition 1.0 2009-12



IEC

625

63-1

:200

9

®

colourinside



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•2000 FFDM approved

1995 2015• •

Technologies


FDA events

•1996 5MP CRT

•1999 5MP LCD

•2000 Dynamic LCD

•2001 9MP LCD

•2003 Tiled

•2005 Projection

•2006 Portables

•2006 Flexibles

•2007 8MP+

•2010 Retina

•2011 Stereo

•2007 TG18


Ehsan Sameia!


TG18 Members:













Lois RutzGammex/RMI









IEC 62563-1Edition 1.0 2009-12



IEC

625

63-1

:200

9

®

colourinside



--`,``,``,`,`,,``````,,,`,,,-`-`,,`,,`,`,,`---


•2001 Soft-copy FFDM cleared

1995 2015• •

Technologies


FDA events

•1996 5MP CRT

•1999 5MP LCD

•2000 Dynamic LCD

•2001 9MP LCD

•2003 Tiled

•2005 Projection

•2006 Portables

•2006 Flexibles

•2007 8MP+

•2010 Retina

•2011 Stereo

•2007 TG18


Ehsan Sameia!


TG18 Members:













Lois RutzGammex/RMI









IEC 62563-1Edition 1.0 2009-12



IEC

625

63-1

:200

9

®

colourinside



--`,``,``,`,`,,``````,,,`,,,-`-`,,`,,`,`,,`---



•2003 Mammo LCD cleared

1995 2015• •

Technologies


FDA events

•1996 5MP CRT

•1999 5MP LCD

•2000 Dynamic LCD

•2001 9MP LCD

•2003 Tiled

•2005 Projection

•2006 Portables

•2006 Flexibles

•2007 8MP+

•2010 Retina

•2011 Stereo

•2007 TG18


Ehsan Sameia!


TG18 Members:













Lois RutzGammex/RMI









IEC 62563-1Edition 1.0 2009-12



IEC

625

63-1

:200

9

®

colourinside



--`,``,``,`,`,,``````,,,`,,,-`-`,,`,,`,`,,`---




•2010 FFDM down-classified

1995 2015• •

Technologies


FDA events

•1996 5MP CRT

•1999 5MP LCD

•2000 Dynamic LCD

•2001 9MP LCD

•2003 Tiled

•2005 Projection

•2006 Portables

•2006 Flexibles

•2007 8MP+

•2010 Retina

•2011 Stereo

•2007 TG18


Ehsan Sameia!


TG18 Members:













Lois RutzGammex/RMI









IEC 62563-1Edition 1.0 2009-12



IEC

625

63-1

:200

9

®

colourinside



--`,``,``,`,`,,``````,,,`,,,-`-`,,`,,`,`,,`---





•2011 First app cleared

1995 2015• •

Technologies


FDA events

•1996 5MP CRT

•1999 5MP LCD

•2000 Dynamic LCD

•2001 9MP LCD

•2003 Tiled

•2005 Projection

•2006 Portables

•2006 Flexibles

•2007 8MP+

•2010 Retina

•2011 Stereo

•2007 TG18


Ehsan Sameia!


TG18 Members:













Lois RutzGammex/RMI









IEC 62563-1Edition 1.0 2009-12



IEC

625

63-1

:200

9

®

colourinside



--`,``,``,`,`,,``````,,,`,,,-`-`,,`,,`,`,,`---





•2011 First app cleared

•2011 DBT mode approved

Outline

1 Reasons for standardization

2 The AAPM WGMD and TG196

3 The IEC 62B/MT51

4 Intercomparison overview

5 Summary

Reasons for standardization The AAPM WGMD and TG196 The IEC 62B/MT51 Intercomparison overview Summary

Reasons for standardization

CDRH is invested in the development of medical devicestandards and participates significantly in thedevelopment process.

Consensus and recognized standards facilitate regulatoryreview.

CDRH participates in 550 national and internationalstandard committees250 staff experts1061 recognized standards

Facilitates a common ground for innovation

Badano – Summit on Color in Medical Imaging, 4/2013 Imaging Physics Laboratory, DIAM/OSEL/CDRH/FDA 5/22


Why standardize image display?

The diagnostic imaging chain is as effective as itsweakest component!

Poor display quality can:Reduce effectiveness of diagnostic or screening test

Cause inconsistent clinical decisions



AAPM

AAPM: The American Association of Physicists inMedicine, professional organization in the field of medicalphysics, ie, physics in biology and medicine.

Mission: To advance the science, education andprofessional practice of medical physics.

Goals: . . . To disseminate scientific and technicalinformation in the discipline, and to promote standardsfor the practice of medical physics.

Board of Directors/Science Council/ImagingPhysics/Imaging Informatics SC/Work Group on MedicalDisplay/TG196 - Requirements and methods for colordisplays in medicine.



AAPM’s WGMD

Purpose: The Working Group on Medical Displaysprovides guidelines to clinicians, medical physicists,developers, and engineers as to the use of display devicesfor image viewing across a variety of disciplines andspecialties.

WGMD identifies display use and performance testingmethodologies that would benefit from increasecommunication between industry and medicalprofessionals, and from tutorial and guideline documents.

Chair: A Badano.



AAPM’s TG196

Provide guidelines to clinicians, medical physicists,developers, and engineers for proper implementation,utilization, and performance testing of color displays formedical use.

The specialties of interest include radiology, cardiology,pathology, dermatology, and other medical disciplines thatuse color images.

Co-Chairs: A Badano, E Samei, and H Roehrig.



Previous and current work at AAPM - I

TG18: Assessment of display performance for medicalimaging systems. Guidelines and acceptance criteria foracceptance testing and quality control of medical displaydevices.

deckard.mc.duke.edu/∼samei/tg181



Previous and current work at AAPM - II

Limitations of TG18

Widely used in radiology.

Grayscale-centered. Only “color” aspect: multi-headconsistency.

Already somewhat obsolete in terms of displaytechnology - needs revising.

TG196: Color displays

First task- gray tracking

Intercomparison of color meters

Report out by end of 2013

Other areas might include handhelds and 3D.



Previous and current work at AAPM - IIIgray tracking color coordinates, expressed in CIE chromaticity (u’,

v’) pairs, of a set of display pixel valuescorresponding to equal driving levels for all subpixelelements, spanning the entire range of luminance of acalibrated display device. This is also referred to as“white point” or “grayscale” tracking performance.

Distance plot for gray, red, green, and blue color patterns with respect to a common reference standard (“truth”).

1E. Samei et al., Med Phys 32, 1205–1225 (2005).



IEC

The International Electrotechnical Commission preparesand publishes international standards for electrical andelectronic technologies.

Over 10,000 experts from industry, government, test andresearch labs, academia and consumers.

95 Technical Committees and 77 Subcommittees

SC62B Diagnostic imaging equipment (27 countries, 17working groups) prepares publications for safety andperformance of medical diagnostic imaging equipment.



IEC62B/MT51

MT51 Medical electrical equipment - Medical imagedisplay systems - Part 1: Evaluation methods. 7countries: US, BR, BE, JP, SE, CN, DE (2009).

Convenor: A Badano.

Limitations of IEC62563-1: Grayscale only.

Maintenance plan:

First amendment: gray tracking, following the work ofTG196 (2013)Second amendment: color space or white pointcoordinates, tbd (2014)Second edition: major revision (2015)



Intercomparison of color meters

Goal: What are the achievable levels of characterizationfor ’grayscale tracking’ for reference and non-referenceinstruments?

Process:

Gather performance data for reference and non-referencesensors used in labs and field

One display sent to all participants

Every participant measures and reports to central lab

Central lab collects, anonymizes, and processes allmeasurements

Results discussed and published as technical note inMedical Physics



Participating Labs

LaboratoriesJP1, JP2, JP3, BE, US1, US2, BR.

Instrumentsi1, Spec, CAS140, CS100A, CS1000, CA310, CS2000, PR730,Topcon SR3 . . .

Data showed per lab/meter combination.



Sample results I



Sample results II

Distance plot for gray, red, green, and blue color patterns with

respect to a common reference standard (“truth”).



Other efforts in standards and guidelines

Display Metrology Committee of Video Electronics StandardsAssociation (VESA) for third version of “Flat Panel DisplayMeasurements Standard”2.

ICDM (International Committee for Display Metrology) ischarged with setting standards for display metrology.Publishes the Information Display Measurements Standard,with 140 display measurements (http://icdm-sid.org/).

Professional guidelines with generalrecommendations/requirements for the practice.

2VESA, “Flat Panel Display Measurements Standard, Version 2.0”, technical report (VESA, 2003).



What one step, if any, would you suggest we take

in order to improve the handling of color in medical

imaging systems within your area of expertise?

Coordination of efforts and recommendation/guidelinesacross disciplines with more involvement from vendors.

Consistent approaches for multi-component analyses.



Final remarks

More work is needed but requires more resources andincreased participation of stakeholders (homeworkassignment).

Not to hinder innovation in devices, it’s the standardapproach/methodology that allows for different and novelimplementations.


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