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
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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=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=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=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=26 Desaturation Validation of INVSENSOR00006
Healthy
Primary: Oxygen Saturation (SpO2) Accuracy of Sensor — 1.16 % of oxygen saturated hemoglobin
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=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=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=14 Accuracy of ScanWatch Pulse Oximeter With Profound Hypoxia
Oximetry
Primary: RMSE Compared to CO-oximetry — 2.97; 3.00 RMSE (%)
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
N/A N=11 SpO2 Accuracy Comparison of Smart Sock V. 2 SpO2 to Arterial Blood CO-Oximetry
Hypoxia
Primary: It Was Expected That the Accuracy Root Mean Square (ARMS) Between Measured SpO2 of Owlet Smart Sock V2 v1.1 and Reference SpO2 Would Meet the Required Specification of…
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=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=38 Desaturation Validation of INVSENSOR00039
Healthy
Primary: Oxygen Saturation (SpO2) Accuracy of Sensor — 1.0 percentage of oxygen saturation
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=12 SpO2 Accuracy of Noninvasive Pulse Oximeter Sensor
Healthy · Hypoxia
Primary: Accuracy of Sensor by Arms Calculation — 1.62; 1.56; 1.48; 1.72 Root Mean Square Error (%)
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=20 Comparison of Tissue Oxygenation Measurement Using Multimodal Devices
Oxygen Saturation
Primary: Device-wise Comparison of Tissue Oxygenation Measurement — 62.7; 91.2; 97.58; 97.95 percentage of oxygen
N/A N=12 In Vivo Pulse Oximeter Validation Study
Hypoxia
Primary: Measure of Accuracy (ARMS [%]) — 2.95 Percentage
N/A N=30 Oxygen Reserve Index (ORi) Validation of INVSENSOR00029
Healthy
Primary: Sensitivity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values. — 93.63 percentage of true positives
N/A N=12 Clinical Study of Peripheral Capillary Oxygen Saturation (SpO2): Vital Signs Patch (VSP)
Desaturation of Blood
Primary: Composite Outcome Measure: Successful Capture of Peripheral Capillary Oxygen Saturation (SpO2) Level — 12 participants
N/A N=100 Oxygen Saturation Patterns in Post-Op Patients at Risk for Obstructive Sleep Apnea
Obstructive Sleep Apnea
Primary: Presence of Repetitive Reductions in Nasal Airflow Patterns in the Pulse Oximetry Saturation Trend Data. — 30 participants
N/A N=27 Oxygen Reserve Index (ORi) Validation of INVSENSOR00025
Healthy
Primary: Specificity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values. — 94.82; 90.69; 100 percentage of true negatives
N/A N=29 Oxygen Reserve Index (ORi) Expanded Data Set Validation of INVSENSOR00025
Healthy
Primary: Concordance for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values. — 99.68; 92.94; 91.48 percentage of accuracy
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=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=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=29 Oxygen Reserve Index (ORi) Expanded Data Set Validation of INVSENSOR00029
Healthy
Primary: Concordance for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values — 99.4; 89.74; 89.86 percentage of accuracy
N/A N=12 SpO2 Accuracy of Noninvasive Disposable Pulse Oximeter Sensor
Healthy · Hypoxia
Primary: Accuracy of Sensor by Arms Calculation — 2.04; 2.11 Root Mean Square Error (%)