Accuracy & Usability Study for Soberlink Cellular Device

Soberlink Healthcare

Status

Completed

Conditions

Substance Abuse

Treatments

Device: BACtrack S80 Pro

Device: Soberlink Cellular Device

Study type

Interventional

Funder types

Industry

Identifiers

NCT02794038

ACUSPROT 2016-001

Details and patient eligibility

About

This study scope is to validate the accuracy and usability of the Soberlink Cellular Device in comparison to a predicate device, BACtrack S80 Pro.

Full description

The purpose of this accuracy and usability study is to validate the performance of Soberlink Cellular Device in the hands of the intended (lay) users - untrained study participants who have consumed alcohol and use the Soberlink Cellular Device to measure their blood alcohol content (BAC) in comparison to a predicate device.

The purpose of this document is to define how the human factors environment impacts the actual user interface design as well as how usability engineering evaluates user interface via usability objectives and usability tests. This accuracy and usability study will be performed on Soberlink Cellular Device in order to comply with FDA's Draft Guidance for Industry and Food and Drug Administration Staff, titled: Applying Human Factors and Usability Engineering to Optimize Medical Device Design, IEC 60601-1-6 (collateral standard for usability engineering of medical electrical equipment), and IEC 62366 (application of usability engineering to medical devices).

Enrollment

43 patients

Sex

All

Ages

21 to 99 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Subject willing to sign an informed consent
Male or female subject between the ages of 21-99 years old
Untrained subject in the use of an Alcohol Breathalyzer
Subject willing to consume two alcoholic drinks
Subjects willing to use two Alcohol Breathalyzers
Subject willing to complete a Questionnaire

Exclusion criteria

Subject with previous Alcohol Breathalyzer experience
Subject currently in substance use rehabilitation or post rehabilitation, or unauthorized to consume alcohol for any other reason
Subject with lung disease, or is physically unable to provide a deep lung exhalation for 4 seconds
Subject unwilling to drink two alcoholic drinks
Subject unwilling to complete a questionnaire
Subject that is non-English speaking
Subject that is a child, adolescent, or cognitively impaired.
Subject that is a pregnant and/or breastfeeding woman