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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 AlcoDigital Breathalyzer AT576, AT577, AT578, AT579 are designed to measure deep lung air to determine the level of alcohol in the blood. The relationship between alcohol in the blood and in the deep lung breath is well established by Henry's law in ratio of 2100:1. The alcohol sensor is electrochemical fuel cell type, and the unit has been designed to blow 6 seconds to get the sample of alcohol, the sensor generates an output by electronic voltage, which is proportional to the concentration of alcohol in the blood. The unit is powered by 1 pcs 9V battery or DC12V input.

Here's an analysis of the provided 510(k) summary for the AlcoDigital Breathalyzer, organized according to your request:

Acceptance Criteria and Device Performance Study

The 510(k) summary presents a comparison between the subject device (AlcoDigital Breathalyzer, Model AT576, AT577, AT578, AT579) and a predicate device (AlcoHAWK PT500 Digital Alcohol Detector, K080848) to establish substantial equivalence. The primary acceptance criterion highlighted and the related performance is "Accuracy."

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document implicitly suggests that the predicate device met similar accuracy criteria, and thus established a benchmark for substantial equivalence. However, the specific accuracy of the predicate is not explicitly stated in this segment.

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

The provided 510(k) summary states that "A clinical trial was performed to establish that the user could read and understand the instructions provided, and properly use the device." However, it does not specify the sample size used for this clinical trial (test set) or the data provenance (e.g., country of origin, retrospective or prospective nature).

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

The document does not provide information regarding the number of experts used to establish ground truth or their qualifications. The "clinical trial" mentioned focuses on user understanding and proper device use, not on validating the accuracy against an expert-established ground truth. Breathalyzers typically establish ground truth against laboratory-grade reference instruments or blood alcohol content (BAC) measurements.

4. Adjudication Method for the Test Set

The 510(k) summary does not specify any adjudication method for the test set.

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 done. This type of study is more common for diagnostic imaging AI, where multiple human readers interpret cases with and without AI assistance. This device is a direct measurement tool, not an interpretive aid for human readers.

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

The document mentions "bench and user testing" and "A clinical trial was performed to establish that the user could read and understand the instructions provided, and properly use the device." The "Accuracy" specification (±0.005% at 0.05%) suggests some level of standalone technical performance evaluation was conducted, likely in a laboratory bench setting to assess the sensor's precision against controlled alcohol concentrations. However, a dedicated study explicitly labeled "standalone performance" is not described with methodological detail. The clinical trial focused on user interaction with the device.

7. The Type of Ground Truth Used

The most common ground truth for breathalyzers is Blood Alcohol Content (BAC) measured through a laboratory reference method (e.g., gas chromatography) or a highly accurate, calibrated reference breath alcohol instrument. While the 510(k) summary states the device "generates an output by electronic voltage, which is proportional to the concentration of alcohol in the blood," it does not explicitly state how the ground truth for the accuracy claim (±0.005% at 0.05%) was established for the testing that generated this figure. It's implied a reference standard was used, but not specified.

8. The Sample Size for the Training Set

The 510(k) summary does not mention a training set sample size. Breathalyzers, particularly those based on electrochemical fuel cells, utilize established physical principles and calibrated sensors rather than machine learning algorithms that require large training datasets in the same way an AI diagnostic device would. Therefore, the concept of a "training set" for an algorithm isn't directly applicable in the typical sense for this device.

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

As there's no mention of a "training set" in the context of an algorithm, the document does not describe how ground truth for a training set was established.

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