Clinical Performance of Masimo INVSENSOR00057 for Heart Rate Measurements

This study is designed to compare the accuracy of a noninvasive measurement of heart rate compared to reference values obtained by a standard of care ECG monitor.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Device: Masimo INVSENSOR00057

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Irvine, California, United States, 92618
      • Masimo Corporation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Subject is 18 to 80 years of age.
• Subject is able to read and communicate in English.

Exclusion Criteria:

• Subject has open wounds, inflamed tattoos or piercings on the area of device placement, and/or has any visible healing wounds that the investigator and/or medical professional determines may place them at an increased risk for participation.
• Subject has any medical condition which in the judgment of the investigator and/or study staff, renders them ineligible for participation in this study or subject is deemed ineligible by the discretion of the investigator/study staff.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Masimo INVSENSOR00057; All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo INVSENSOR00057 device.	Device: Masimo INVSENSOR00057; Noninvasive wearable health monitoring device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate Accuracy of Masimo INVSENSOR00057	Heart rate accuracy was determined by calculating the accuracy root mean-squared (Arms) difference between the measured values from Masimo INVSENSOR00057 (TestHR_i) to the reference ECG monitor values (RefHR_i). Arms= √(∑(i=1 to n) ((TestHR_i-RefHR_i )^2 ))/n	1-3 hours

Collaborators and Investigators

• Sponsor: Masimo Corporation

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2022
• Primary Completion (Actual): July 21, 2022
• Study Completion (Actual): July 21, 2022

Study Registration Dates

• First Submitted: July 14, 2022
• First Submitted That Met QC Criteria: July 14, 2022
• First Posted (Actual): July 18, 2022

Study Record Updates

• Last Update Posted (Actual): September 24, 2024
• Last Update Submitted That Met QC Criteria: September 3, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: CIP-1020

Drug and device information, study documents

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