HOLOGIC’ Statement of Equivalency APEX Version 4.5 and 3.5 to APEX Version 4.0 or 3.4 Background [APEX is the software that runs sfering hardware platforms for Hologe Densttometers. APEX Version ‘45 runs on Windows 7. APEX Version 3.5 rune on Windows XP. APEX 4.5 and 3.5 can analyze eoane ‘acquired previous Halogc software versions ard oblan ential esuls to se obi tt APEX 4. ord. APEX 45 and 3.6 can aco analyze ecane acquired or mpored io APEX 6.5 and obtain ‘denical sul o those obtained n APEX 6.6, A. AU ka Kevin Wilson, PHD Peter Lewis Selentfe Dector Sr. Manager, Sofware Engineering HOLOGIC, nex 35C05hy Crom Bool UA O30 Te 815687500m Fs 720080 wewhse cas Mawos117 Revision 002 Page 1017HOLOGIC” ‘Statement of Equivalency APEX Version 4.0 and 3.4 to APEX Version 3.3 Background APEX-40 runs on the Windows 7 operating system and includes visceral fat as a standard option for whole Body scans (avalablty may depend on regulatory approval in your country). APEX 3.8 runs on Windows XP and does not suppor the wisceral at option, Refer to the release notes (MAN-09083) for 2 complete stg ofthe new features. ‘Scan Acquisition ‘Scan acquision fr al scan modos supported by APEX 33 is Kentca in APEX 3.44.0, Analysis Results APEX 3.4 and 4.0 analysis resus are dential to results in APEX 2.3, excert as noted below. APEX 34 and 4.0 produce very slightly ferent body composition value (et, lean, and derivative values of fat and leah, such sta) when” NHANES BCA iS enabled in te systom Configuration. In previous versions of APEX, the NHANES BCA callration for Tat and lean sof sue FAT oupsacs =FATe ne + 0.084% (Leatcane+ BMC) Leatnyuyasscs =TotalMass ~ BMC FAT puyssce Where the subscript ciasi" refers to the fat or sft issue lean mass as measured when NHANES BCA. is not enabled. in APEX 4.0 and 3.4, the more sccurata ealtration for fat an lean which more accurately matches the Schooler ofa (Am. J Gin. Na. 2006:81: 1000-25) used FAT ansacs = FATetaae + 0.054% Lette Leathsuyasecs =TotalMass ~ BMC = ‘Since BMC is very small in value compared lo the lean soft issue mass, this change in calibration is within the procsion error expect fora repeat moasurament. In a test &f 600 adults, age 16:72, the ‘erage difference between tho bo methods was 0.16% fat and the maxmum diffrence obwerved inthis atasel was 0.25% fat (2229 of al). However, users shouldbe aware tat reanalysis of whole body Scan ‘wit NHANES BCA enabled wil gve slighty dere resus from previous versions of APEX for fat, ean, ‘nd lean + SMC mae, but BNC, total mass and BMD sre unaffected ‘Scans analyzed without NHANES BCA enabled In APEX 4.0 and 3.4 ghe intial results to previous ‘versione of APEX, except APEX 4.0 has adtonal eeu rom the acer ft ei, NHANES BCA enabled isthe default method, but tis can be changed under system utes, In, APEX 4.0 and 3.4, the Lean Indges have changed to net include BMC. ngravious versions of APEX ‘we ropoced (Lean + BMC)Meight” and appendculr (Leen * BMCYMeigh®, wth matchng relerenes ‘ala. APEX 4.0 and 3.4 have resticed the Lean Indies to sof seu fo agree wth pubaned iterate land expert guidlines. The Lean Indices are. now Lean/Height” and appencigular Learoigh, with matching Tefrence dota. When LeanlMelght” and appondeular Leanireigh® are aplayed in tho ‘Advanced WB report for a scan that had NHANES BCA enabled cunng analys, the Lean ad HOLOGIC, Ine.» 36 Croty Dow Ga, WAG? Ta 7840070 Fa 72128008006 nc wass03117 Revion on2 PagetHOLOGIC’ ‘Agpencicular Lean are calusted using te APEX 4.034 NHANES BCA correction. Adétional, for the BCA rate of change Repor, Lean Mass without BMC is now avalable and Is calculated using the APEX ‘4.0134 NHANES BCA correction. For other BCA reprts for sears analyzed with old versions (APEX 3.3 real), Lean mass not updated tothe new NHANES BCA method High Power Whole Body: NHANES callraton can now be applied te High Power Whole Body, Infant Whole body: Infant whcle body is a special acquisition mode for babies rom the ages of bith 0 year old. To increase accuracy, caltaton of the fat and lean mass on Infant WB has been changed on Discovery W, Wi and Explorer modes resuting In greator fat mace. The previous calibration in APEX 3.3 ‘and ear rosuted in ronphyiologcal results fr tome very lan infant, To obtain the new calration, Feanaiyze the previously seaured infant Whole bosy sean by ekcking onthe “Global RO?" bution during ‘analysis and then on "Resulls" Rearchive the scan eave these new result, “The caloration ofA model scan for Infant whole body has net been changed, In APEX 40 and 3.3, te bone dge detection in HSA has been Improved to bolr detoct bone with very thin corices. Usually, thi wl result in very minor dflerences HSA results, however, very rary (depends on the populaton, but approximately 1 in 900 for elery women) where the previous mined of edge detacton fale to find the corical edge prope, the New ‘method wl produce very ciferent recut rom previous versions of APEX HSA on ths person Forearm: APEX 3.4 nd 4.0 redices the minimum foaaem length for analysis to 4c Reference data changes ‘Note whether reference database Is appropiate for use with @ given patients results is atthe sale lisretion ofthe physician, thors many factors fe possby consider, Inoudng gender, ethnciy, county of ‘rg, Body hablus and other pation! spect factors, [APEX 40 and 34 has made thefolowing changes tothe default relerence databases: = For Whole body scans NHANES reference data Is avalable forthe "Non NHANES callraton * which produces lower fat and matches the body composi caliraton tat was standard price toAPEX *+ fat reference curves fe right andlor ght an lft og, trunk and Subtotal ae included, + NHANES White Whole Body BMD versus age reference data is extended down to age 3 using the Hologe Pediatric reference data forages 56 and the BMOCS feerenca dats af age 7. * New whole body pediatic curves Lean vs Height and Lean vs Subtotal BMC with the defintion of, {Lean oxolucing BMC ore noludod ‘The APEX reference data is exended to support Zscoces for White subjects greater than 85 years old Zescotes forthe AP Spine reference dala is extonded by comparing those people above age 85 to 85 year olds for calculation of zscores ony. Reference data stucies {ypically have minimal secual at these ‘ages and many siuces (such 2s NHANES) lump participants above age 85 together nthe elegory 66 when they publish ther data, Kevin Wilson, PAD Peter E. Lewis Scientie Dsctor [57 Manager, Software Engineering OLOGIC, nsw 56 Cty Com esos MA CITIO8 To 7840073 Fc T128005008 a cn Maw.117 Revision 22 Page’37HOLOGIC’ Statement of Equivalency APEX Version 3.3 to APEX Version 3.2 Background APEX 9.3 integrated the Whole Body NHANES Reference deta’ Into APEX 3.2 and added color represeniaton of the inage, displaying pictorialy fa. lean and bone, Yo the clinical body composition report. Ths mage isnot for diagnostic use ‘Scan Acquisition ‘Scan acquisition fr al scan modes supported by eatlir versions of APEX is ldentioa in APEX $3 Analysi ‘APEX 3.8 analysis resuls are erica! to rosults obtained wih APEX 2.2. Results APEX 3.3 has Went sults for all parameters (EMD. fa, lean, and 80 on) ax APEX 32 Howover, ‘APEX 3.3 Z-scores and "scores for Whole Body exams may fer when update wih the new NHANES data. To analyze whole todysoane using the NHANES rofecence data, enable the ‘NHANES Caliration™ ‘option inthe Analysis ab ‘To display color images on the Cincal Boéy Compositon Report and Body Composition Rate of Change report, you must acquire the scan wi APEX 3.3 or with APEX 40+ wih BCA Whole Body Reporting ‘ption outside tho Unites States onl), Kevin Wilson, PAD Peter E. Lewis Seientie Drector Sr. Manager, Software Engineering "Kelly TL, Wiloo, KF Heys, SB 2009) Daal energy X-Ray absorptiometry body composition reference ‘alot fom NHANES. PLoS One e703, 4 704900790 Fo 701380000» mena MAW 117 Revi 002 Page $0r"1HOLOGIC" ‘Statement of Equivalency ‘APEX Version 3.2 to APEX Version 3.1 Background APEX represents tt latest bone densiy application software and replaces previous versione of APEX, ‘Scan Acquisition ‘Span ccquiaton fo al scan modes aupperted by earier versione of APEX fs Kenta in APEX 9.2. Analysis, APEX 3.2 analysis esuls are identical to results obtained wih APEX 3.1 except for Whole Body sears ‘which could not be analyzed with APEX 3 (ths was lined to ecane snalyzed wih the computer date Set in & non-US format, ‘esuling Inthe message “The scan contains no Besue calbration Gala), APEX 32 repars these scane 80 that hey can now be analyzed. The repared scans Tay Nave very minor “ferences in body compostion results (wall within machine precision) from the same whole Body soars ‘analyzed vith previous versions of APEX. Results APEX 3.2 and APEX 3.1 T-score ané Z-ecores ate identical for all suppeted analysis types, scan types, ‘and rogions. If new refecence data is loaded into APEX 3.2, 0.9 wth the release of a new Reference Database option, T-soores and Z-scores may change. in such cases consul the release notes for the ‘ewy nsalled Reference Database option fr more deal, Fracture Risk iscalulted automaticaly in APEX 3.2 using FRAX® 3.1. H newer versions of FRAX* are loaded ito the APEX 32 sofware, e.g with the release of a naw FRAX® opton containing & newer FRAX" version, Fracture risk values, supported counes, supported ethnicities, ete. may change. In such cases consul the release notes forte newly installd FRAX option for more coala Kevin Wilson, PAD Peter. Lewis ‘Soente Director ‘Sr Manager, Sofware Engineering HOLOGIC, nc 35 Cosy Dv Boo MA C179 T7851 990730 Fa 7208 eco uawo3t17 Roviion 002 Pageset7HOLOGIC’ Statement of Equivalency Of APEX Version 3.1 to APEX Version 3.0.1 Background [APEX 8.1 represenis thelatest bone density appicaton software, replacing previous versions of APEX, ‘Scan Acquisition ‘Scan acquisition fr al sean modes supported by eater versions of APEX isidnticalin APEX 3.0. Analysis and BMD Values Identical results are obtaned with all supported APEX 3.1 analyse as compared fo APEX 2.0.1 [APEX 8.1 supports a new AP Spine analysis method for subjects age zero to hee years old. The ‘analysis of subjects age 3 and under éopends onthe accurate scan date an date crn. Thus, is Important thatthe operator enter the corec date of bith and thatthe dete o! the computer be accurate ‘Adctonaly tis imporan that scans fo subecs Tes than four years old no have fir can date and ‘ato ofbithdeidentfed or scan tanater, as ths will enange analysis results # the eran fe reanalyzed. Results APEX 3.1 gives identical T- and Z-scores compared to APEX 3.0.1 fr all supported analysis types scan ‘ypes and rogions. I new rference data becomes avalable and is loaded into APEX 31 (e.g withthe release of @ now opter) T- and Z-scores may change and the release nots and statement of ‘equivalency forthe reference database option should be consulted Fracture Risk is calculated automatically using FRAX® version 3.0. For non-UISA counts that were ‘avalebe In APEX 3.01, minor aferoness (ast significant cgt) may be absewed. This is due to Glerences between FRAX V 1.1 (a8 used In APEX 3.0.1) and FRAX 3.0, The mitor differences in how Inputs ito FRAX are rounded account for be dilerence between FRAX 1:1 and FRAK 30. USA regions ‘wore not avaiable In APEX version 3.0.1. Using the FRAK program embeded ino APEX 3.1, thee I 'o need for an adjustment of T-scoes or Z-eoores as le necessary forthe Web-based version of FRAX. Tor some combination of genders and etirictes. Kevin Wison, PhO Poter E, Lewis Sclettic Drectoe Sr Manager, Sofware Engineering HOLOGIC, Inc. $8 Cy Divo Bato MAOI7IDn Te 781999 7300m Fe 72800680 wom MaN99117 Revisor 072 Page borHOLOGIC" Statement of Equivalency (Of APEX Version 3.0.1 to APEX Version 2.3 or 2.4 Background ‘APEX. represents the atest bone density application softwere, replacing provicus versions of APEX. ‘Scan Acquisition ‘Scan acquisition fr al s:an modes supported by eaiervorsions of APEX s ental in APEX 2.0. ‘Analysis and BMD Values Idemical suits are obtaines with al supperiod APEX 3.0.1 analysis as compared te APEX 2.9 or APEX 24 See the APEX 23 e 24 Statoment of Equivalency for eiferences with APEX 20,21 and 22 [APEX 3.0.1 no longer supports analysis of whole body scan from scanners that dé not have body ‘composition installed ant enablod at scan time. Whale Body in APEX 3.0.1 comes standard with Body ‘composton. Whether an oder whole body scanner wahout body composition can te upgraded to APEX 3.0% depends onthe scanner’ date of manufacture. Please contact customer serdce er Your dealer “with the Serial number ofthe seannor in question before atemping to upgrade @ whale body scanner without body composition to APEX 3.0.1 APEX 3.0.1 no longer supports “pediatric whole body” analysis. Tho “pediatric whol body" analysis was Improved and incorporated int the sanders “Auto W" analysis which provides superior results in ‘chidren compared wih “seditric whole bod". but requires body compostton being part ofthe scan ‘Auto WE analysis st became the standard wiole body analyes in GOR for Windows XP V124. The ‘Adto WE" onaysis sno: changed in APEX 2.0.1, APEX 3.0.4 wll no lorge: provide legacy “Low Density Spin as an analysis type availabe or new Patients. Hologc strongly discourages the use ofthe Low Density Spine analy, as twas made, ‘obsolete by improvemens inthe standard AP Spine analysis (wth Auto Low Density) However or ‘etutring patients f you sse Compare and the Baseline scan was analyzed with Lov Deny Spine, the sofware wil use the’ Low Densiy Spine analysis onthe follow-up scan eo that rates of ehange canbe ‘measured using th samo anaysis method. Ifthe Low Dens Spine analyst method s used or ropored fon itis important to consult the “ADR Reference Mantua” en the CD thats abeled “QDR Reference, Documents for further formation a special coneiceratons regarding the use of ts analysis ethos, Results ‘APEX 3.0.1 gives identical T- and Z-scores compared to APEX 2.3 ot 2.4 for al supported analysis types scan types and regions. H new reference data becomes avaiable and is loaded nto APEX 30.1 fe withthe release ofa new option) T- and Z-scores may change and the release notes and elatoment of teaulvaleney forthe reference database option should be consulted Fracture Fisk is calculated automatically using FRAX® version 1.1. Using the FRAK program embeded into APEX 3.0.1, toro sno need Toren adjustment of T-score or Z-scores as ls necessary fr tne Web basod version of FRAX Ter some combinaton of genders and ethnics, Kevin Wilson, PHO Potor E Levis Seentie Drector Sr. Manager, Sofware Engineeting HOLOGIC, In. «2 Ciny Diem Ban UAOI7SDm To 760720 Fak TE 250068 «mas con Maw.03117 Reson 002 Pago 7 07