To evaluate the performance, the RMSE and coverage rate were calculated using the pooled SpO 2 errors. The data rejection rate was calculated as (1-coverage rate). The coverage rate was defined as the percentage of valid sample points out of the total time asleep. The RMSE was calculated using the squared error (SpO 2Ref-WristO 2) of all valid sample points when both the SpO 2Ref and WristO 2 data were available. The performance of the target device was evaluated using the RMSE and coverage rate. Performance evaluation of WristO 2 and the association between AHI and GW4-ODI The GW4 automatically rejected the periods showing distorted waveforms distant from the arterial waveform and movements detected from accelerometers.
To exclude falsely calculated values resulting from motion or venous pulsation, SpO 2 values were screened using the morphology of PPG waveforms and stability of the output data.
PULSE OXIMETER SLEEP MONITOR ISO
During a previous in-laboratory test following the International Organization for Standardization (ISO) 8 2017 standard, we confirmed that the performance of the GW4 conforms to the United States Food and Drug Administration (FDA) guidelines and the ISO standard requirements of root mean squared errors (RMSEs) less than 3.5% and 4%, respectively. The SpO 2 level was estimated based on the R-value using the predefined calibration information. The perfusion index (PI) and R-value were calculated as PI λ = AC λ/DC λ and R-value = PI λRed ⁄ PI λIR, respectively. Then, the AC and DC were measured based on the recent PPG waveform within a window.
Briefly, noise in the PPG waveform was eliminated using a low-pass filter (fc = 12.5 Hz). A well-defined alternating component (AC)/direct component (DC) method was used to calculate SpO 2.
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