F - 9
F.3
The Accuracy of Nellcor SpO
2
Sensors
Modified Bland-Altman for SpO
2
- MAX-A, MAX-P Sensors (No Motion): SaO
2
vs. (SpO
2
-
SaO
2
)
Sensor
Motion
# of Data Points
A
RMS
(%)
SpO
2
Acceptance
Criteria 70% - 100%
(%)
Pass/Fail
MAX-A, MAX-P
No
976
1.54
≤2.0
Pass
MAX-I, MAX-N
No
723
1.41
≤2.0
Pass
DS-100A
No
411
2.16
≤3.0
Pass
D-YS, OXI-P/I, OXI-A/N
No
458
1.96
≤3.5
Pass
1. SpO
2
- SaO
2
(%)
2. SaO
2 (%)
3. Upper 95% LoA
4. Mean Bias
5. Lower 95% LoA
