Limitations
comorbidity
As this study was conducted in a controlled laboratory setting, it is unlikely that we were able to fully replicate or adequately represent device performance in the actual clinical environment. This study was conducted using healthy volunteer subjects without significant illness or comorbidity, which is not representative of a typical patient population, particularly in acute care. Moreover, our sample for subjects with darker skin pigmentation was small, limiting the use of these results in this patient population. The study was not powered to examine the impact of motion or low perfusion on any patient subgroups. Finally, because of the low number of observations of ultra low PI (N = 21), no meaningful conclusions of SpO