Accuracy & Usability Study for Soberlink Cellular Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 主要终点
- Validate the accuracy of the Soberlink Cellular Device in comparison to a predicate device, BACtrack S80 Pro and assessed by linear regression.
研究概览
简要总结
This study scope is to validate the accuracy and usability of the Soberlink Cellular Device in comparison to a predicate device, BACtrack S80 Pro.
详细描述
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 This accuracy and usability study will be performed on Soberlink Cellular Device in order to comply with FDA's Draft Guidance for Industry and Food and Drug Administration Staff, titled: Applying Human Factors and Usability Engineering to Optimize Medical Device Design, IEC 60601-1-6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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Soberlink Cellular Device
BAC reading with Soberlink Cellular Device
干预措施: BACtrack S80 Pro (Device)
BACtrack S80 Pro
BAC reading with BACtrack S80 Pro
干预措施: Soberlink Cellular Device (Device)
结局指标
主要结局
Validate the accuracy of the Soberlink Cellular Device in comparison to a predicate device, BACtrack S80 Pro and assessed by linear regression.
时间窗: Day 1
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.
次要结局
- Validate the usability of the Soberlink Cellular Device in comparison to a predicate device, BACtrack S80 Pro and assessed by Questionnaire.(Day 1)