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The Breath Alcohol Detector is for the semi-quantitative rapid detection of the presence of alcohol in the exhaled breath. The Breath Alcohol Detector indicates relative Blood Alcohol Concentration (BAC) at 0.02%, 0.04%, 0.05%, 0.06%, 0.08% or 0.10% cut-off levels. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.

The Breath Alcohol Detector is a visual semi-quantitative test for the detection of alcohol in the exhaled breath. The Breath Alcohol Detector consists of a plastic tube, two plastic plugs, a blow bag (optional), a tube label and a glass vial encased with reaction crystals. The crystals employ a solid-phase chemistry system based on chemically chromogenic reaction. Alcohol, if present in the exhaled breath, reacts with the chemically coated crystals and produces a color change. This color change is proportional to the concentration of alcohol in the breath, which is an approximation of relative Blood Alcohol Concentration (BAC). The Breath Alcohol Detector is available with or without blow bags in six cut-off levels: 0.02%, 0.04%, 0.05%, 0.06%, 0.08% or 0.10% cut-off levels.

Here's a breakdown of the acceptance criteria and study information for the Mission® Breath Alcohol Detector, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria in a table format. However, it implies that the device had to demonstrate properties equivalent to the predicate device and meet certain performance characteristics. It indicates that the device achieved "comparable readings" to a DOT/NHTSA approved evidential breath test device.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size for Test Set: The document does not specify the exact number of individuals (laypersons and trained laboratory technicians) who participated in the clinical study. It states that "Clinical studies were conducted with laypersons and trained laboratory technicians."
• Data Provenance: The data was gathered from a prospective clinical study specifically conducted for this device. The country of origin for the data is not explicitly stated, but the submitting company (ACON Laboratories, Inc.) is based in San Diego, California, USA, and the predicate device is from New Jersey, USA, suggesting the study was likely conducted in the USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• Number of Experts: Not explicitly stated. The ground truth was established by "trained laboratory technicians" using an "evidentiary breath test, Alco-Sensor IV."
• Qualifications of Experts: The experts were described as "trained laboratory technicians." Their specific experience (e.g., years of experience) is not provided, but their use of a DOT/NHTSA approved device implies they are qualified operators of such equipment for accurate breath alcohol measurement.

4. Adjudication Method for the Test Set:

• The document does not describe an adjudication method in the typical sense of expert review for discrepancies. Instead, the study directly compared the device's readings obtained by laypersons to the results obtained by trained technicians using a reference device (Alco-Sensor IV). The 'ground truth' was assumed to be the Alco-Sensor IV reading.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No, a formal MRMC comparative effectiveness study was not reported. The study focused on comparing the performance of the device (operated by laypersons) against a reference device (operated by trained technicians), not on comparing multiple human readers with and without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• This device is a physical, chromogenic reaction test. It actively involves a human user blowing into it and visually interpreting the results. Therefore, a "standalone algorithm only" performance evaluation is not applicable and was not performed. The performance of the device without a human "in the loop" doesn't make sense for this type of product.

7. The Type of Ground Truth Used:

• The ground truth was established by an evidentiary breath test (Alco-Sensor IV) which is a DOT/NHTSA approved device. This represents a highly reliable, accepted method for measuring breath alcohol concentration, essentially acting as the gold standard for comparison in this context.

8. The Sample Size for the Training Set:

• The document does not provide information regarding a separate "training set" or its sample size. This type of chemical-based, visual read device typically undergoes analytical validation and clinical validation, rather than a machine learning model's training and testing split. The "analytical performance characteristics" and "clinical study" sections describe the validation process.

9. How the Ground Truth for the Training Set Was Established:

• Given that no machine learning training set is mentioned or implied, this question is not applicable. The "ground truth" for the overall validation was established by the Alco-Sensor IV as described above.

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