N/A N=26 Desaturation Validation of INVSENSOR00006
Healthy
Primary: Oxygen Saturation (SpO2) Accuracy of Sensor — 1.16 % of oxygen saturated hemoglobin
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N/A N=29 Desaturation Validation of INVSENSOR00012
Healthy
Primary: Oxygen Saturation (SpO2) Accuracy of Sensor — 1.99 % of oxygen saturated hemoglobin
N/A N=21 Desaturation Validation of INVSENSOR00031
Healthy
Primary: Oxygen Saturation (SpO2) Accuracy of Sensor by Arms Calculation During Non-motion — 1.33 % of oxygen saturated hemoglobin
N/A N=38 Desaturation Validation of INVSENSOR00039
Healthy
Primary: Oxygen Saturation (SpO2) Accuracy of Sensor — 1.0 percentage of oxygen saturation
N/A N=16 Desaturation Validation of INVSENSOR00009
Healthy
Primary: Trending Regional Oxygen Saturation Accuracy of the INVSENSOR00009 Relative to the Control Sensor by Arms Calculation — 1.3 % tissue oxygen saturation
N/A N=23 Desaturation Validation of INVSENSOR00028
Healthy
Primary: Oxygen Saturation (rSO2) Accuracy of Sensor
N/A N=11 Accuracy of Noninvasive Pulse Oximeter Sensor (Rainbow DCI)
Healthy
Primary: Accuracy of Sensor by Arms Calculation — 1.6 % of oxygen saturated hemoglobin
N/A N=35 SpO2 Validation of Noninvasive Red Diamond Disposable Pulse Oximeter Sensor
Healthy
Primary: Accuracy of Red Diamond Disposable Pulse Oximeter Sensor by Arms Calculation — 1.16 percent of oxygen saturated hemoglobin
N/A N=13 Desaturation Validation of INVSENSOR00038
Healthy
Primary: Trending Accuracy of INVSENSOR00038 — 2.5 percentage of regional oxygen saturation
N/A N=21 Oxygen Saturation Monitoring During Surgery
Sleep Apnea, Obstructive
Primary: Number of Participants With Saturation Pattern Detection (SPD) Indicative of Repetitive Reductions in Air Flow — 4; 0 Participants
N/A N=27 Accuracy of Oxygen Saturation (SpO2) Noninvasive Pulse Oximeter Sensor (RD Disposable) Under Motion Conditions
Healthy
Primary: SpO2 ARMS of Sensor Under Motion Conditions — 1.31 % of oxygen saturated hemoglobin
N/A N=18 Accuracy of SpO2 for Noninvasive Pulse Oximeter Sensor (RD DCI)
Healthy
Primary: Accuracy of Sensor by Arms Calculation — 1.9 % of oxygen saturated hemoglobin
N/A N=14 Accuracy of ScanWatch Pulse Oximeter With Profound Hypoxia
Oximetry
Primary: RMSE Compared to CO-oximetry — 2.97; 3.00 RMSE (%)
N/A N=13 Accuracy of Noninvasive Pulse Oximeter Sensor (LNCS DBI)
Healthy
Primary: Accuracy of Sensor by Arms Calculation — 1.69 % of oxygen saturated hemoglobin
N/A N=60 Effect of Super-Oxygenated Water on Blood Oxygen Saturation
Adult Subject
Primary: SpO2 Response Rate — 21; 11 Participants — p=0.010
Phase 3 N=18 Controlled Acute Hypoxia Study Comparing Pulse Oximetry to Arterial Blood Samples During Motion
Healthy · Hypoxia
Primary: SpO2 Accuracy During Motion Conditions - MaxA Sensor — 1.78 Accuracy Root Mean Square
N/A N=13 Accuracy of SpO2 for Noninvasive Pulse Oximeter Sensor (LNCS ADTX)
Healthy
Primary: Accuracy of Sensor by Arms Calculation — 2.0 % of oxygen saturated hemoglobin
N/A N=12 In Vivo Pulse Oximeter Validation Study
Hypoxia
Primary: Measure of Accuracy (ARMS [%]) — 2.95 Percentage
N/A N=245 Tissue Oxygenation During Treatment of Infant Congenital Heart Defects
Acute Kidney Injury · Hypoxia-Ischemia, Brain · Mesenteric Ischemia
Primary: Number of Participants With Acute Kidney Injury — 18; 57 Participants
N/A N=13 Accuracy of Pulse Oximeters With Profound Hypoxia at Rest
Hypoxia
Primary: Accuracy of Sensor Oxygen Saturation by Arms Calculation — 0.86 percentage of RMS error
N/A N=132 Accuracy of Noninvasive Hemoglobin Pulse Oximeter (Rainbow Resposable Adhesive Sensors)
Healthy
Primary: Accuracy of Sensor by Arms Calculation — 1.0 g/dL
N/A N=25 Accuracy of Methemoglobin Measurement for Rainbow DCI Sensors
Healthy
Primary: Accuracy of Sensor by Arms Calculation — 0.87 percentage
N/A N=11 Accuracy of Pulse Oximeters With Profound Hypoxia At Rest (NIHO16)
Hypoxia
Primary: Accuracy of Sensor Oxygen Saturation by Arms Calculation — 2.0 percentage of SpO2
N/A N=11 Accuracy of Pulse Oximeters With Profound Hypoxia At Rest (NIHO17)
Hypoxia
Primary: Accuracy of Sensor Oxygen Saturation by Arms Calculation — 2.0 percentage of SpO2
N/A N=14 Accuracy of Owlet Smart Sock Sensor 3rd Generation With Profound Hypoxia
Hypoxia
Primary: SpO2 Accuracy (Arms) of ≤3 Between 70 and 100% — 2.10; 2.19 Percentage
N/A N=12 Accuracy of Pulse Oximeters With Profound Hypoxia At Rest (NIHO18)
Hypoxia
Primary: Accuracy of Sensor Oxygen Saturation by Arms Calculation — 2.0 percentage of SpO2
N/A N=28 Accuracy of Methemoglobin Measurement of Various Rainbow Pulse Oximeter Sensors
Healthy
Primary: Accuracy of Methemoglobin Measurement by Arms Calculation — 0.48 percentage of total hemoglobin
N/A N=51 Accuracy of Methemoglobin Measurement for Rainbow Universal Pulse Oximeter Sensor
Healthy
Primary: Accuracy of Sensor by Arms Calculation — 0.63 Percentage of total hemoglobin
N/A N=20 Comparison of Two Devices Using Near-infra Red Spectroscopy During a Vascular Occlusion Test
Healthy
Primary: Change of Tissue Oxygenation Value During Ischemia and Reperfusion Period Until Basline Value Was Achieved — 17.9; 13.5; 280.0; 186.5 %/min — p=<0.05
N/A N=88 Performance of Masimo MightySat Pulse Oximeter in Differing Levels of Skin Pigmentation
Healthy
Primary: SpO2 Accuracy of the MightySat Pulse Oximeter — 1.30 % of oxygen saturated hemoglobin