Femur Certification Corridors for the Inverse Test (Zero Cross Timing)
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1 Femur Certification Corridors for the Inverse Test (Zero Cross Timing) 8th IG GTR9-PH2 meeting Japan Automobile Standards Internationalization Center (JASIC) 1
2 Background At the 7th IG GTR9-PH2 meeting, the BASt method (GTR9-6-07: cut test data during Flex-PLI rebound phase) was agreed to be used in the GTR9 Phase 2 text. However, in the BASt method, femur outputs of Flex-PLI, which are not validated in the dynamic certification test of Flex-PLI, are used. Therefore, it was requested to BASt or someone to develop a requirement to confirm femur output validity. Based on the above situations, Japan volunteered to develop femur zero cross timing certification corridors for the inverse test using two methodologies. 2
3 Methodology (1) BASt Method 3
4 Methodology (1) Corridor making method BASt method (TF-RUCC-4-04), which was used to develop tibia and knee ligaments (ACL, PCL, MCL) corridors. TF-RUCC
5 Test data Master leg (SN01, SN03, E-leg) test data (zero cross timing) which were obtained at the Master test lab (JARI, BASt, Bertrandt) Bending Moment (Nm) Femur-1 Femur-2 Femur-3 Acceleration (G) Knee-Acc Time (ms) Time (ms) 300 Bending Moment (Nm) Time (ms) 25 Tibia-1 Tibia-2 Tibia-3 Tibia-4 Impact timing is determined by knee acceleration output. (zero cross timing of knee acceleration is set as impact timing) Bending Moment (Nm) Knee-ACL Knee-PCL Knee-MCL Time (ms) 5
6 1) Definition of reproducibility corridors 1.1.) CV calculation of all segments of each impactor 1.2.) Determination of segments for reproducibility corridor; Requirement: CV < 5% Original Test Data Zero Cross Timing (ms) CV Values lfd Nr. Test # Femur 3 Femur 2 Femur 1 CV Values Femur 3 Femur 2 Femur 1 P1 SN01@JARI, Setup 1 - SN01 - JARI 1.7% 4.9% 0.8% P2 SN01@JARI, Pass Pass Pass P3 SN01@JARI, P4 SN03@JARI, Setup 2 - SN03 - JARI 2.2% 1.0% 0.9% P5 SN03@JARI, Pass Pass Pass P6 SN03@JARI, P7 E-leg@JARI, Setup 3 - E-leg - JARI 0.5% 0.6% 0.1% P8 E-leg@JARI, Pass Pass Pass P9 E-leg@JARI, P10 SN01@BASt, Setup 4 - SN01 - BASt 0.1% 0.2% 0.2% P11 SN01@BASt, Pass Pass Pass P12 SN01@BASt, P13 SN03@BASt, Setup 5 - SN03 - BASt 6.8% 0.9% 0.7% P14 SN03@BASt, Over 5% Pass Pass P15 SN03@BASt, P16 E-leg@BASt, Setup 6 - E-leg - BASt 0.5% 0.6% 0.5% P17 E-leg@BASt, Pass Pass Pass P18 E-leg@BASt, P19 SN01@Bertrandt, Setup 7 - SN01 - Bertrandt 0.6% 0.5% 0.5% P20 SN01@Bertrandt, Pass Pass Pass P21 SN01@Bertrandt, P22 SN03@Bertrandt, Setup 8 - SN03 - Bertrandt 0.4% 0.6% 1.4% P23 SN03@Bertrandt, Pass Pass Pass P24 SN03@Bertrandt, P25 E-leg@Bertrandt, Setup 9 - E-leg - Bertrandt 0.4% 0.3% 0.2% P26 E-leg@Bertrandt, Pass Pass Pass P27 E-leg@Bertrandt,
7 Removed: CV Values Over 5% Test Data lfd Nr. Test # Femur 3 Femur 2 Femur 1 P1 SN01@JARI, P2 SN01@JARI, P3 SN01@JARI, P4 SN03@JARI, P5 SN03@JARI, P6 SN03@JARI, P7 E-leg@JARI, P8 E-leg@JARI, P9 E-leg@JARI, P10 SN01@BASt, P11 SN01@BASt, P12 SN01@BASt, P13 SN03@BASt, P14 SN03@BASt, P15 SN03@BASt, P16 E-leg@BASt, P17 E-leg@BASt, P18 E-leg@BASt, P19 SN01@Bertrandt, P20 SN01@Bertrandt, P21 SN01@Bertrandt, P22 SN03@Bertrandt, P23 SN03@Bertrandt, P24 SN03@Bertrandt, P25 E-leg@Bertrandt, P26 E-leg@Bertrandt, P27 E-leg@Bertrandt, ) Calculation of pooled means of all segments with CV < 5% (a) Pooled Mean with CV < 5% (b) Limit Value Upper: (a) +10% (c) Limit Value Upper: (a)-10% ) Calculation of reproducibility corridors (limit values); pooled mean +/- 10% 7
8 2) Definition of certification corridors Determination of reproducible test results Test # Femur 3 Femur 2 Femur 1 SN01@JARI, SN01@JARI, SN01@JARI, SN03@JARI, SN03@JARI, SN03@JARI, E-leg@JARI, E-leg@JARI, E-leg@JARI, SN01@BASt, SN01@BASt, SN01@BASt, SN03@BASt, SN03@BASt, SN03@BASt, E-leg@BASt, E-leg@BASt, E-leg@BASt, SN01@Bertrandt, SN01@Bertrandt, SN01@Bertrandt, SN03@Bertrandt, SN03@Bertrandt, SN03@Bertrandt, E-leg@Bertrandt, E-leg@Bertrandt, E-leg@Bertrandt, ) Determination of reproducible test results 2.2) Determination of maxima and minima for each segment Maximum Minimum Max. x Min. x Certification Corridor Upper Round Certification Corridor Lower Round 2.3) Determination of corridor limits (maxima + 5%, minima -5%) 2.4) Round 2.3) values to define certification corridors 8
9 Comparison to certification corridors Compared to Certification Corridors Test # Femur 3 Femur 2 Femur 1 SN01@JARI, SN01@JARI, SN01@JARI, SN03@JARI, SN03@JARI, SN03@JARI, E-leg@JARI, E-leg@JARI, E-leg@JARI, SN01@BASt, SN01@BASt, SN01@BASt, SN03@BASt, SN03@BASt, SN03@BASt, E-leg@BASt, E-leg@BASt, E-leg@BASt, SN01@Bertrandt, SN01@Bertrandt, SN01@Bertrandt, SN03@Bertrandt, SN03@Bertrandt, SN03@Bertrandt, E-leg@Bertrandt, E-leg@Bertrandt, E-leg@Bertrandt, All test data fall within the certification corridors. Certification Corridor Upper Round Certification Corridor Lower Round 100% 100% 100% Pass Pass Pass 9
10 Comparison to certification corridors All test data fall with the certification corridors. Zero Cross Timing (ms) SN01@JARI, T-01 SN01@JARI, T-02 SN01@JARI, T-03 SN03@JARI, T-01 SN03@JARI, T-02 SN03@JARI, T-03 E-leg@JARI, T-01 E-leg@JARI, T-02 E-leg@JARI, T-03 SN01@BASt, T-01 SN01@BASt, T-02 SN01@BASt, T-03 SN03@BASt, T-01 SN03@BASt, T-02 SN03@BASt, T-03 E-leg@BASt, T-01 E-leg@BASt, T-02 E-leg@BASt, T-03 SN01@Bertrandt, T-01 SN01@Bertrandt, T-02 SN01@Bertrandt, T-03 SN03@Bertrandt, T-01 SN03@Bertrandt, T-02 SN03@Bertrandt, T-03 E-leg@Bertrandt, T-01 E-leg@Bertrandt, T-02 E-leg@Bertrandt, T-03 Corridor - Upper Corridor - Lower 0 Femur-3 Femur-2 Femur-1 10
11 Comparison between Zero Cross Timing Corridor Location of Femur and Maximum Value Generate Timing of Tibia and Knee Outputs Bending Moment (Nm) Femur Femur-1 Femur-2 Femur-3 Zero cross timing corridor location of Femur (around 45 +/- 5 ms) Bending Moment (Nm) Bending Moment (Nm) Time (ms) Time (ms) Tibia Tibia-1 Tibia-2 Tibia-3 Tibia-4 Knee Knee-ACL Knee-PCL Knee-MCL Maximum values generate timing of Tibia and Knee outputs (used for Tibia/Knee injury assessment) If zero cross timing of femur falls into the developed corridor, it is clear that no concerns to be cut maximum values of Tibia and Knee inappropriately during an inverse certification test. The corridor width (around +/- 5 ms) acceptability is evaluated using several car tests. (see following slides) Time (ms) 11
12 Zero cross timing Acceptable Zero cross timing corridor width (around +/- 5 ms) Maximum value generates timing regarding Tibia and Knee outputs
13 Zero cross timing Acceptable Zero cross timing corridor width (around +/- 5 ms) Maximum value generates timing regarding Tibia and Knee outputs
14 Zero cross timing Acceptable Zero cross timing corridor width (around +/- 5 ms) Maximum value generates timing regarding Tibia and Knee outputs
15 Zero cross timing Acceptable Zero cross timing corridor width (around +/- 5 ms) Maximum value generates timing regarding Tibia and Knee outputs
16 Methodology (2) BASt Method with Modifications 16
17 Methodology (2) Corridor making method BASt method (TF-RUCC-4-04), which was used to develop tibia and knee ligaments (ACL, PCL, MCL) corridors, with some modifications. TF-RUCC-4-04 Modifications Average values Average +/- Acceptable Tolerance (15 ms) Acceptable tolerance (+/- 15 ms) is determined using car test results. (see Appendix 1) 17
18 Same as Methodology (1) Test data Master leg (SN01, SN03, E-leg) test data (zero cross timing) which were obtained at the Master test lab (JARI, BASt, Bertrandt) Bending Moment (Nm) Femur-1 Femur-2 Femur-3 Acceleration (G) Knee-Acc Time (ms) Time (ms) 300 Bending Moment (Nm) Time (ms) 25 Tibia-1 Tibia-2 Tibia-3 Tibia-4 Impact timing is determined by knee acceleration output. (zero cross timing of knee acceleration is set as impact timing) Bending Moment (Nm) Knee-ACL Knee-PCL Knee-MCL Time (ms) 18
19 Same as Methodology (1) 1) Definition of reproducibility corridors Original Test Data Zero Cross Timing (ms) 1.1.) CV calculation of all segments of each impactor 1.2.) Determination of segments for reproducibility corridor; Requirement: CV < 5% CV Values lfd Nr. Test # Femur 3 Femur 2 Femur 1 CV Values Femur 3 Femur 2 Femur 1 P1 SN01@JARI, Setup 1 - SN01 - JARI 1.7% 4.9% 0.8% P2 SN01@JARI, Pass Pass Pass P3 SN01@JARI, P4 SN03@JARI, Setup 2 - SN03 - JARI 2.2% 1.0% 0.9% P5 SN03@JARI, Pass Pass Pass P6 SN03@JARI, P7 E-leg@JARI, Setup 3 - E-leg - JARI 0.5% 0.6% 0.1% P8 E-leg@JARI, Pass Pass Pass P9 E-leg@JARI, P10 SN01@BASt, Setup 4 - SN01 - BASt 0.1% 0.2% 0.2% P11 SN01@BASt, Pass Pass Pass P12 SN01@BASt, P13 SN03@BASt, Setup 5 - SN03 - BASt 6.8% 0.9% 0.7% P14 SN03@BASt, Over 5% Pass Pass P15 SN03@BASt, P16 E-leg@BASt, Setup 6 - E-leg - BASt 0.5% 0.6% 0.5% P17 E-leg@BASt, Pass Pass Pass P18 E-leg@BASt, P19 SN01@Bertrandt, Setup 7 - SN01 - Bertrandt 0.6% 0.5% 0.5% P20 SN01@Bertrandt, Pass Pass Pass P21 SN01@Bertrandt, P22 SN03@Bertrandt, Setup 8 - SN03 - Bertrandt 0.4% 0.6% 1.4% P23 SN03@Bertrandt, Pass Pass Pass P24 SN03@Bertrandt, P25 E-leg@Bertrandt, Setup 9 - E-leg - Bertrandt 0.4% 0.3% 0.2% P26 E-leg@Bertrandt, Pass Pass Pass P27 E-leg@Bertrandt,
20 Same as Methodology (1) Removed: CV Values Over 5% Test Data lfd Nr. Test # Femur 3 Femur 2 Femur 1 P1 SN01@JARI, P2 SN01@JARI, P3 SN01@JARI, P4 SN03@JARI, P5 SN03@JARI, P6 SN03@JARI, P7 E-leg@JARI, P8 E-leg@JARI, P9 E-leg@JARI, P10 SN01@BASt, P11 SN01@BASt, P12 SN01@BASt, P13 SN03@BASt, P14 SN03@BASt, P15 SN03@BASt, P16 E-leg@BASt, P17 E-leg@BASt, P18 E-leg@BASt, P19 SN01@Bertrandt, P20 SN01@Bertrandt, P21 SN01@Bertrandt, P22 SN03@Bertrandt, P23 SN03@Bertrandt, P24 SN03@Bertrandt, P25 E-leg@Bertrandt, P26 E-leg@Bertrandt, P27 E-leg@Bertrandt, ) Calculation of pooled means of all segments with CV < 5% (a) Pooled Mean with CV < 5% (b) Limit Value Upper: (a) +10% (c) Limit Value Upper: (a)-10% ) Calculation of reproducibility corridors (limit values); pooled mean +/- 10% 20
21 2) Definition of certification corridors Determination of reproducible test results Test # Femur 3 Femur 2 Femur 1 SN01@JARI, SN01@JARI, SN01@JARI, SN03@JARI, SN03@JARI, SN03@JARI, E-leg@JARI, E-leg@JARI, E-leg@JARI, SN01@BASt, SN01@BASt, SN01@BASt, SN03@BASt, SN03@BASt, SN03@BASt, E-leg@BASt, E-leg@BASt, E-leg@BASt, SN01@Bertrandt, SN01@Bertrandt, SN01@Bertrandt, SN03@Bertrandt, SN03@Bertrandt, SN03@Bertrandt, E-leg@Bertrandt, E-leg@Bertrandt, E-leg@Bertrandt, ) Determination of reproducible test results 2.2) Determination of average values Average Average + 15 ms Average - 15 ms Certification Corridor Upper Round Certification Corridor Lower Round 2.3) Determination of corridor limits (Average + 15 ms, Average - 15 ms) 2.4) Round 2.3) values to define certification corridors 21
22 Comparison to certification corridors Compared to Certification Corridors Test # Femur 3 Femur 2 Femur 1 SN01@JARI, SN01@JARI, SN01@JARI, SN03@JARI, SN03@JARI, SN03@JARI, E-leg@JARI, E-leg@JARI, E-leg@JARI, SN01@BASt, SN01@BASt, SN01@BASt, SN03@BASt, SN03@BASt, SN03@BASt, E-leg@BASt, E-leg@BASt, E-leg@BASt, SN01@Bertrandt, SN01@Bertrandt, SN01@Bertrandt, SN03@Bertrandt, SN03@Bertrandt, SN03@Bertrandt, E-leg@Bertrandt, E-leg@Bertrandt, E-leg@Bertrandt, All test data fall within the certification corridors. Certification Corridor Upper Round Certification Corridor Lower Round 100% 100% 100% Pass Pass Pass 22
23 Comparison to certification corridors All test data fall with the certification corridors. Zero Cross Timing (ms) SN01@JARI, T-01 SN01@JARI, T-02 SN01@JARI, T-03 SN03@JARI, T-01 SN03@JARI, T-02 SN03@JARI, T-03 E-leg@JARI, T-01 E-leg@JARI, T-02 E-leg@JARI, T-03 SN01@BASt, T-01 SN01@BASt, T-02 SN01@BASt, T-03 SN03@BASt, T-01 SN03@BASt, T-02 SN03@BASt, T-03 E-leg@BASt, T-01 E-leg@BASt, T-02 E-leg@BASt, T-03 SN01@Bertrandt, T-01 SN01@Bertrandt, T-02 SN01@Bertrandt, T-03 SN03@Bertrandt, T-01 SN03@Bertrandt, T-02 SN03@Bertrandt, T-03 E-leg@Bertrandt, T-01 E-leg@Bertrandt, T-02 E-leg@Bertrandt, T-03 Corridor - Upper Corridor - Lower 0 Femur-3 Femur-2 Femur-1 23
24 Comparison between Zero Cross Timing corridor for Femur and Maximum values generate timing of tibia and knee outputs Bending Moment (Nm) Femur Femur-1 Femur-2 Femur-3 Zero cross timing corridor (around 42 +/- 15 ms) Bending Moment (Nm) Bending Moment (Nm) Time (ms) Time (ms) Tibia Tibia-1 Tibia-2 Tibia-3 Tibia-4 Knee Knee-ACL Knee-PCL Knee-MCL Maximum values generate timing of Tibia and Knee outputs (used for Tibia/Knee injury assessment) If zero cross timing of femur falls into the developed corridor, it is clear that no concerns to be cut maximum values of Tibia and Knee inappropriately during an inverse certification test. The corridor width (around +/-15 ms) acceptability is already evaluated using several car test results. (see Appendix 1) Time (ms) 24
25 Summary Japan developed femur zero cross timing certification corridors for the inverse test voluntarily using two different methodologies with Master leg (SN01, SN03, E-leg) test data (zero cross timing) which were obtained at the Master test lab (JARI, BASt, Bertrandt) <Methodology (1)> Femur-3: (ms), Femur-2: (ms), Femur-1: (ms) <Methodology (2)> Femur-3: (ms), Femur-2: (ms), Femur-1: (ms) All Master leg test data falls into the above corridors. In the BASt method, zero cross timing is used to cut rebound phase test data. Therefore, Japan proposes to set femur zero cross timing certification corridors for the inverse test which are obtained by Methodology (1) or Methodology (2). 25
26 Appendix 1: Determination of Acceptable Tolerance for Zero Cross Timing 26
27 Appendix 1: Determination of Acceptable Tolerance for Zero Cross Timing Acceptable tolerance of zero cross timing is determined using car test results which are described in the BASt document (GTR9-6-07). 27
28 Appendix 1: Determination of Acceptable Tolerance for Zero Cross Timing Zero cross timing Maximum value generates zone of Tibia and Knee ligaments Acceptable tolerance of zero cross timing around +/-20 ms in the maximum
29 Appendix 1: Determination of Acceptable Tolerance for Zero Cross Timing Zero cross timing Maximum value generates zone of Tibia and Knee ligaments Acceptable tolerance of zero cross timing around +/-15 ms in the maximum
30 Appendix 1: Determination of Acceptable Tolerance for Zero Cross Timing Zero cross timing Maximum value generates zone of Tibia and Knee ligaments Acceptable tolerance of zero cross timing around +/-15 ms in the maximum
31 Appendix 1: Determination of Acceptable Tolerance for Zero Cross Timing Zero cross timing Maximum value generates zone of Tibia and Knee ligaments Acceptable tolerance of zero cross timing around +/-15 ms in the maximum
32 Appendix 1: Determination of Acceptable Tolerance for Zero Cross Timing Summary Acceptable tolerance of zero cross timing is determined using car test results which are described in the BASt document (GTR9-6-07). Based on the analysis, acceptable tolerance is determined as around +/-15 ms. 32
33 Appendix 2: Comparison to certification corridors (Flex-GTRs in Japan) 33
34 Appendix 2: Comparison to certification corridors (Flex-GTRs in Japan) Additionally, zero cross timing of Flex-GTRsin Japan at inversetest data were randomly selected then compared to the certification corridors. Flex-GTRs in Japan: J-Leg-B series (delivered before 12 June 2012) INFO: All of the Flex-GTRsfall into the latest Tibia and Knee Ligaments maximum value inverse test corridors (developed by TF-RUCC, then accepted by IG GTR9- PH2at the 4th meeting in Sep. 2012). 34
35 Appendix 2: Comparison to certification corridors (Flex-GTRs in Japan) All test data falls within the certification corridors obtained by Methodology (1). 80 SN01-Min. 70 SN01-Max. SN03-Min. Zero Cross Timing (ms) Master Legs Flex-GTRs in Japan Master Legs Flex-GTRs in Japan Master Legs Flex-GTRs in Japan SN03-Max. E-leg-Min. E-leg-Max. J-Leg-B02-T1 J-Leg-B03-T1 J-Leg-B04-T1 J-Leg-B0A-T1 J-Leg-B0Ev2-T1 20 J-Leg-B1-T1 J-Leg-B3-T1 10 J-Leg-B7-T1 Corridor - Upper 0 Femur-3 Femur-2 Femur-1 Corridor - Lower 35
36 Appendix 2: Comparison to certification corridors (Flex-GTRs in Japan) All test data falls within the certification corridors obtained by Methodology (2). 80 SN01-Min Master Legs Flex-GTRs in Japan Master Legs Flex-GTRs in Japan Master Legs Flex-GTRs in Japan SN01-Max. SN03-Min. SN03-Max. E-leg-Min. Zero Cross Timing (ms) E-leg-Max. J-Leg-B02-T1 J-Leg-B03-T1 J-Leg-B04-T1 J-Leg-B0A-T1 J-Leg-B0Ev2-T1 J-Leg-B1-T1 J-Leg-B3-T1 J-Leg-B7-T1 Corridor - Upper 0 Femur-3 Femur-2 Femur-1 Corridor - Lower 36
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