Appendix B Clinical Study Summary - Henry Schein MD300K2 Instrucciones De Uso

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:
A Value Analysis Statement
RMS
Item
#pts
Bias
ARMS
Bland-Altman Plot Graphic
Clinical study details of MD300K2 Pulse Oximeter and its supporting M-50B008CS09
Oximeter probe:
A Value Analysis Statement
RMS
Item
#pts
Bias
ARMS
26
90--100
78
-0.73
1.46
90--100
78
-0.10
1.19
80--<90
74
-0.59
1.80
80--<90
74
-0.31
1.40
70--<80
66
0.45
1.99
70--<80
66
-0.03
1.82