Masimo Opioid Halo User Manual page 56

Clinical testing found the equivalent SpO
identified by a Massey-Martin scale score of 4 or higher.
Group No. Subjects Bias MAB Prec. ARMS LOA
Light 13 0.05
Dark 9 0.03
The below Bland-Altman plot represents the correlation of the (SpO
under no motion with an upper 95% and lower 95% limits of agreement.
Figure 1: Residual plot with repeated measures adjusted LOA for overall flattened dataset
Opioid Halo Performance Testing
The Opioid Halo Performance was tested for 2 things: 1. How well severe OIRD was detected or
"sensitivity". 2. How well it doesn't falsely detect severe OIRD or "specificity". The sensitivity and
specificity can be a number between 0-100%. The higher the percentage the better the performance.
However, it can be difficult to understand what a good percentage is without a comparison. Therefore, it
was compared to a benchmark of a pulse oximeter alarm of 90% SpO
helps to see the improvement provided by Opioid Halo.
Because there are different types of opioids used in different places, the testing was done on 4 different
type of opioid users: 1. Naïve users or those just prescribed opioids, 2. Chronic users or those who are
regularly prescribed opioids, 3. Hospital users or those who are being administered opioids in a hospital
setting, 4. Illicit users or those who are using opioids without a prescription. There was a total of 641
performance between light and dark subjects. Dark subjects
2
1.48 1.79 1.79 [-3.46 3.56] 449
1.34 1.74 1.75 [-3.39 3.45] 313
Npairs
+ SaO
2
for greater 30s. The benchmark
2
54
)/2 versus (SpO - SaO
2 2
)
2