ALADDIN
- User manual
Rev. 19 EN of 10/07/2019
160
2) Spearman correlation coefficients and related p-values for hypothesis H
0
Spearman
= 0 between
mean and standard deviation were provided for each endpoint.
Analysis described in previous point 1 and 2 was provided for ALADDIN HW3.0 and LENSTAR LS 900
separately.
Details about REML analysis: model terms will be estimated by using sum of squares.
The results of the analysis of repeatability and reproducibility are summarized in Table 2:
Table 2
Repeatability and reproducibility.
DEVICE
Endpoint Overall Mean
REPEATABILITY
REPRODUCIBILITY
SD
Limit
% COV
SD
Limit
% COV
ALADDIN HW3.0
AL[mm]
24.04
0.020
0.056
0.084
0.024
0.068
0.100
ALADDIN HW3.0
AX [ ͦ ]
76.73
2.859
8.004
3.726
2.918
8.170
3.803
ALADDIN HW3.0 ACD[mm]
3.67
0.026
0.073
0.708
0.026
0.074
0.721
ALADDIN HW3.0
LT[mm]
3.67
0.031
0.086
0.833
0.032
0.090
0.878
ALADDIN HW3.0 CCT[mm]
0.555
0.005
0.013
0.837
0.005
0.013
0.858
ALADDIN HW3.0 WTW[mm]
12.27
0.066
0.184
0.536
0.066
0.186
0.541
ALADDIN HW3.0 K1_D [D]
43.16
0.077
0.217
0.179
0.082
0.230
0.191
ALADDIN HW3.0 K2_D [D]
44.26
0.121
0.339
0.274
0.127
0.355
0.286
LENSTAR LS 900
AL[mm]
24.05
0.014
0.040
0.059
0.015
0.041
0.061
LENSTAR LS 900
AX [ ͦ ]
76.56
5.304
14.852
6.928
5.312
14.873
6.938
LENSTAR LS 900 ACD[mm]
3.67
0.036
0.100
0.974
0.036
0.102
0.991
LENSTAR LS 900
LT[mm]
3.65
0.052
0.145
1.418
0.053
0.147
1.440
LENSTAR LS 900 CCT[mm]
0.555
0.004
0.011
0.722
0.004
0.011
0.726
LENSTAR LS 900 WTW[mm]
12.30
0.065
0.183
0.532
0.066
0.184
0.533
LENSTAR LS 900
K1_D [D]
43.17
0.114
0.320
0.265
0.118
0.329
0.272
LENSTAR LS 900
K2_D [D]
44.26
0.186
0.522
0.421
0.191
0.535
0.432
Note to Table 2:
-
Repeatability includes variation due to measurement error;
-
Reproducibility includes variations due to the device, the operator, the interaction between device and subject, the
interaction between operator and subject, the interaction between device and operator, the interaction between device,
operator and subject, and measurement errors;
-
Repeatability % COV = (Repeatability SD / abs(overall mean))*100;
-
Reproducibility % COV = (Reproducibility SD / abs(overall mean))*100.
The result of the repeatability and reproducibility study demonstrate that ALADDIN HW3.0 is substantially
equivalent for both repeatability and reproducibility to the predicate device.
The analyses of reproducibility and repeatability shows that ALADDIN HW3.0 and LENSTAR LS 900
performances are substantially equivalent for the assessed endpoints.
Summary of Contents for ALADDIN HW3.0
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