Performance Assessment Study VitalSigns Camera

Summary

This Performance Assessment Study will focus on testing the performance of the VitalSigns Camera under various suboptimal use cases. The software makes it possible to measure the pulse rate (PR) and respiration rate (RR) without the device being in contact with the subject. The software delivers fast and accurate results (in less than one minute). Vital signs camera (VSC) product will be used via a demonstrator app on one of the smartphones during the study sessions (camera of the phone will be used by the VSC product). Devices will be provided by the researchers.

The subject will be asked to perform a number of assignments with the software application. The study involves taking a number of measurements of the subject's PR using the VitalSigns Camera software application (which is installed on a smartphone or laptop). In this study only PR is measured and not RR as the latter parameter is not affected by the designed test cases. The total duration of the session will be approximately 1 hour. In total, approximately 30 healthy volunteers will participate in this study.

Conditions

• Healthy Humans
• Vital Signs Monitoring

Interventions

DEVICE

Happy Flow / Baseline

Baseline (without make-up or mask)

DEVICE

Make-up

To test device on participant who is wearing facial make-up

DEVICE

Sunglasses

To test device on participant who is wearing sunglasses

DEVICE

Face mask

To test device on participant who is wearing a facial mask

DEVICE

Minimum requirements camera

To test the minimum requirements of the camera

DEVICE

Worst case hardware

To test if software still works with an older smartphone

DEVICE

Damaged lens

To test if software is still working when the lens of the smartphone is damaged

DEVICE

Face or chest outside test frame

To test software if the participants face or chest is outside the test frame

Sponsors & Collaborators

• Philips Clinical & Medical Affairs Global

  lead INDUSTRY

Study Design

Allocation

NA

Purpose

OTHER

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-07-07

Primary Completion

2022-07-22

Completion

2022-09-30

FDA Device

Yes

Countries

• United States

Study Locations