Rainbow R2-25 vs. R1-25 SpHb Sub-Range Performance Equivalence

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Device: R1-25 and R2-25 Pulse Oximeter Sensor

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Irvine, California, United States, 92618
      • Masimo Clinical Lab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test group; All subjects will be enrolled in the test group and will receive both R1-25 and R2-25 Pulse Oximeter Sensors	Device: R1-25 and R2-25 Pulse Oximeter Sensor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1-5 hours

Collaborators and Investigators

• Sponsor: Masimo Corporation

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2009
• Primary Completion (Actual): July 2, 2009
• Study Completion (Actual): July 2, 2009

Study Registration Dates

• First Submitted: April 14, 2017
• First Submitted That Met QC Criteria: April 27, 2017
• First Posted (Actual): April 28, 2017

Study Record Updates

• Last Update Posted (Actual): July 27, 2017
• Last Update Submitted That Met QC Criteria: June 28, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: TR18735-1029

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes