Appendix B Clinical Study Summary - Medipost-Nutristoma MD300K2 Mode D'emploi

INSTRUCTION MANUAL

APPENDIX B CLINICAL STUDY SUMMARY

The following details are provided to disclose actual performance observed in the clinical
validation study of healthy adult volunteers. The ARMS value analysis statement and Bland-
Altman plot of data for MD300K2 and its supporting probes are shown as following:
Clinical study details of MD300K2 Pulse Oximeter and its supporting M-50E012CS09
Oximeter probe:
Item
#pts
Bias
ARMS
Clinical study details of MD300K2 Pulse Oximeter and its supporting M-50B008CS09
Oximeter probe:
Item
#pts
Bias
ARMS
A Value Analysis Statement
RMS
90--100
78
-0.73
1.46
Bland-Altman Plot Graphic
A Value Analysis Statement
RMS
90--100
78
-0.10
1.19
- 27 -
80--<90
74
-0.59
1.80
80--<90
74
-0.31
1.40
MD300K2
70--<80
66
0.45
1.99
70--<80
66
-0.03
1.82