Accuracy & Usability Study for Soberlink Cellular Device

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

Detailed Description
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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 This accuracy and usability study will be performed on Soberlink Cellular Device in order to comply with FDA's Draft Guidance for Industry and Food and Drug Administration Staff, titled: Applying Human Factors and Usability Engineering to Optimize Medical Device Design, IEC 60601-1-6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).

Official Title
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Accuracy & Usability Study for Soberlink Cellular Device

Conditions
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Substance Abuse

Intervention / Treatment
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* Device: Soberlink Cellular Device
* Device: BACtrack S80 Pro


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Soberlink Cellular Device<br>BAC reading with Soberlink Cellular Device | Device: BACtrack S80 Pro<br>* BAC breath analyzer<br>|
| Active Comparator: BACtrack S80 Pro<br>BAC reading with BACtrack S80 Pro | Device: Soberlink Cellular Device<br>* BAC breath analyzer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validate the accuracy of the Soberlink Cellular Device in comparison to a predicate device, BACtrack S80 Pro and assessed by linear regression. | Performance validation will occur by evaluating the accuracy of the Soberlink Cellular device in the hand of intended users - untrained study participants who have consumed alcohol and use the device to measure their blood alcohol content (BAC). 40 adults will be recruited who have recently consumed alcohol. The only assistance to be provided is the labeling. No additional coaching, either written or verbal, will be provided to study participants. Participants should obtain a BAC reading with the Soberlink Cellular device, and a second BAC reading with a comparator device. The second measurement will be taken within 5 minutes of the first. A linear regression line for the comparison between results of the Soberlink Cellular device and a comparator will be made. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validate the usability of the Soberlink Cellular Device in comparison to a predicate device, BACtrack S80 Pro and assessed by Questionnaire. | Performance validation will occur by evaluating the usability of the Soberlink Cellular device in the hand of intended users - untrained study participants who have consumed alcohol and used the device to measure their blood alcohol content (BAC). 40 adults who have recently consumed alcohol will be asked to evaluate the Soberlink Cellular device. The only assistance provided is the labeling. No additional coaching, either written or verbal, will be provided to study participants. Participants should obtain a BAC reading with the Soberlink Cellular device, and a second BAC reading with a comparator device. The second measurement should be taken within 5 minutes of the first. Following the second measurement a questionnaire will be administered to study participants to evaluate the ease of use of the Soberlink Cellular device. | Day 1 |