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This device is intended to measure alcohol in human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.

The BACTRACK® Select Breathalyzer is an alcohol screening device, used for the detection of alcohol in the breath. The BACTRACK® provides a digital result, indicating the approximate BAC (Blood Alcohol Content) of the test subject. The BACTRACK® is powered by two AA batteries (two AAA batteries for model S30) and is very easy to use. The device employs a silicon sensor of the same type commonly used in handheld breathalyzers. The units are factory calibrated but the product should be recalibrated at least every six to twelve months. If the product is used every day, it may need to be recalibrated as frequently as every month.

The provided text describes the BACTRACK® Select Breathalyzer (models S30, S50, S70) and its substantial equivalence to a predicate device (AL-5000 K061922 SENTECH KOREA CORP). The device is intended to measure alcohol in human breath for the diagnosis of alcohol intoxication.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the BACTRACK® Select Breathalyzer appear to be based on demonstrating "substantial equivalence" to the predicate device, AL-5000 K061922. The key performance metric explicitly stated for both devices is accuracy.

The text also mentions that a "clinical trial performed showed that the over the counter purchaser of this device could read and understand the instructions, could properly use the device, and obtain results that were comparable to those provided by a professional unit administered by a trained observer." This implies an acceptance criterion for user comprehension and ease of use, leading to comparable results, though specific quantitative metrics are not provided.

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

The document does not explicitly state the sample size used for the test set in the clinical trial. It vaguely refers to a "clinical trial." The data provenance is also not specified; it's unclear if the data was collected in the US or another country, or if it was retrospective or prospective.

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

The document states that the clinical trial results were "comparable to those provided by a professional unit administered by a trained observer." This indicates that the ground truth was established by a "professional unit" and a "trained observer." However, the number of such observers/experts and their specific qualifications (e.g., years of experience, specific medical/technical background) are not provided.

4. Adjudication Method for the Test Set

The adjudication method for establishing ground truth in the clinical trial is not explicitly stated. It can be inferred that the "trained observer" operating a "professional unit" provided the reference measurements, implying a single expert's measurement as the ground truth without a clear adjudication process among multiple experts.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described. The study compared the device's results to a "professional unit administered by a trained observer," rather than comparing human readers with and without AI assistance. Therefore, no effect size for human readers improving with AI vs. without AI assistance can be determined from the provided text.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

The device is a breathalyzer, which is an instrument that directly provides a measurement. Its performance is inherently "standalone" in the sense that it provides a reading. The clinical trial focused on user comprehension and the device's ability to provide results comparable to a professional unit. Therefore, the standalone performance was assessed in terms of its accuracy and comparability to a reference standard, as indicated by the "Accuracy" row in the substantial equivalence chart and the clinical trial description.

7. The Type of Ground Truth Used

The ground truth for the clinical trial was established by a "professional unit administered by a trained observer." This implies a reference measurement obtained using a presumably more accurate or validated professional breath alcohol testing device, rather than pathology, expert consensus (among multiple experts), or outcomes data. This is a form of reference standard.

8. The Sample Size for the Training Set

The document does not provide any information about a "training set" or its sample size. This device is a sensor-based instrument, not a machine learning or AI algorithm that typically requires a training set. Its development and validation would primarily involve engineering and calibration, followed by clinical testing, rather than a machine learning training/testing paradigm.

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

Since there is no mention of a "training set" in the context of this device, this information is not applicable and not provided.

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