Topcon ALADDIN, Руководство пользователя

Страница: 138 / 147

ALADDIN
- User manual Rev. 23 of 08/07/2016
138
were used to estimate: - the reproducibility SD as the square root of model MSE; the reproducibility limit as
reproducibility SD multiplied by 2.88; the reproducibility coefficient of variation as (reproducibility SD / mean)
multiplied 100; - the repeatability SD as the square root of (device variance component es operator
variance component es device*subject variance component es operator*subject variance
component estimate + model MSE); the repeatability limit as repeatability SD multiplied by 2.88; the
repeatability coefficient of variation as (repeatability SD / mean) multiplied 100.
Variability of repeated measures within a subject was assessed before ANOVA modeling to guarantee that
it is fairly constant across the range of results, as proved:
-
plotting the standard deviation of repeated results with eye versus the mean of repeated results
(data not shown);
-
estimating the Spearman correlation coefficient between the standard deviation of repeated results
with eye versus the mean of repeated results (data not shown).
The results of the analysis of repeatability and reproducibility are summarized in Table 2:
TABLE2
Repeatability and reproducibility.
DEVICE Endpoint Overall Mean
REPEATABILITY REPRODUCIBILITY
SD Limit % COV SD Limit % COV
ALADDIN acd 3.397248677 0.027579116 0.079427855 0.811807407 0.519528412 1.496241828 15.29262241
ALADDIN al 23.69804821 0.018530025 0.053366472 0.078192199 0.129821027 0.373884559 0.547813162
ALADDIN
ax for
0.00<=cyl<=0.75
86.90250329 5.519759822 15.89690829 6.351669529 13.3944358 38.57597511 15.41317602
ALADDIN
ax for
0.75<cyl<=1.50
75.94121105 2.224842528 6.407546481 2.929690608 5.955000696 17.150402 7.841593008
ALADDIN ax for 1.50<cyl 75.94121105 1.728735737 4.978758923 2.276413179 4.843085162 13.94808527 6.377413653
ALADDIN k1 42.9413081 0.086388248 0.248798153 0.201177494 0.418268114 1.204612167 0.974046046
ALADDIN k2 43.90794572 0.110161562 0.3172653 0.250892089 0.507055765 1.460320604 1.154815505
ALADDIN wtw 12.27800118 0.065896179 0.189780996 0.536701196 0.264318617 0.761237618 2.152782146
IOLMaster acd 3.327983539 0.048812637 0.140580394 1.46673312 0.241207692 0.694678153 7.247863133
IOLMaster al 23.69269841 0.018705725 0.053872489 0.078951435 0.082094224 0.236431364 0.346495879
IOLMaster
ax for
0.00<=cyl<=0.75
88.66187221 7.444327655 21.43966365 8.39631227 15.80848015 45.52842284 17.83007708
IOLMaster
ax for
0.75<cyl<=1.50
75.96493239 2.164421305 6.233533358 2.849237453 16.539422 47.63353535 21.77244351
IOLMaster ax for 1.50<cyl 75.96493239 1.867818382 5.379316939 2.45879029 5.710886052 16.44735183 7.517792582
IOLMaster k1 43.0005842 0.082012189 0.236195103 0.190723429 0.330063483 0.950582831 0.767579067
IOLMaster k2 43.99408476 0.093346514 0.268837961 0.212179694 0.53105056 1.529425614 1.20709537
IOLMaster wtw 12.30152851 0.092008195 0.264983602 0.747941161 0.445406739 1.282771408 3.620743053
Note to Table 2:
-
Repeatability includes variation due to measurement error;
-
Reproducibility includes variations due to device, operator, interaction between device and subject, interaction between
operator and subject, and measurement error;
-
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 is substantially equivalent
for both repeatability and reproducibility to the predicate device.
Agreement study and reproducibility and repeatability study prove that ALADDIN performances are
substantially equivalent to the predicate device ones for the assessed endpoints.