Healthy
Conditions
Brief summary
In this study, the concentration of hemoglobin was measured using noninvasive pulse oximeter sensors and compared against the hemoglobin measurement from the subject's blood sample under controlled conditions. Data collected in the study was in the sub-range of 12-17 g/dL in the device's 8-17 g/dL specification range. The purpose of the study was to evaluate a change in the sensor component and to assess performance equivalence in the sub-range. The performance of non-invasive hemoglobin is not uniform across the accuracy range.
Interventions
DEVICER1-25 and R2-25 Pulse Oximeter Sensor
Sponsors
Masimo Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Greater than 18 years old * Healthy
Exclusion criteria
* Do not understand the study and the risks involved * Deemed ineligible by study test personnel
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sub-Range Performance Equivalence of R2-25 and R1-25 Sensors by ARMS Calculation | 1-5 hours | Sub-range performance equivalence was determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter sensor to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square (Arms) error value. In order to obtain the Arms value, the blood sample hemoglobin value is subtracted from the pulse oximeter hemoglobin value for a number of samples, the average of this difference is computed as the bias. The standard deviation of these differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Test Group All subjects will be enrolled in the test group and will receive both R1-25 and R2-25 Pulse Oximeter Sensors | 21 |
| Total | 21 |
Baseline characteristics
| Characteristic | Test Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants |
| Region of Enrollment United States | 21 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 21 |
| serious Total, serious adverse events | 0 / 21 |
Outcome results
Primary
Sub-Range Performance Equivalence of R2-25 and R1-25 Sensors by ARMS Calculation
Sub-range performance equivalence was determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter sensor to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square (Arms) error value. In order to obtain the Arms value, the blood sample hemoglobin value is subtracted from the pulse oximeter hemoglobin value for a number of samples, the average of this difference is computed as the bias. The standard deviation of these differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.
Time frame: 1-5 hours
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Test Group | Sub-Range Performance Equivalence of R2-25 and R1-25 Sensors by ARMS Calculation | R2-25 sensor | 1.33 g/dL |
| Test Group | Sub-Range Performance Equivalence of R2-25 and R1-25 Sensors by ARMS Calculation | R1-25 sensor | 1.41 g/dL |