(84 days)
Intended to measure alcohol in the human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.
The AlcoMate is designed to measure deep lung air to test for the presence of alcohol in the blood. The relationship between alcohol in the blood and alcohol in the deep lung breath is well established by Henry's law in ratio of 2100:1 The AlcoMate is a D.O.T. approved alcohol screening device and uses a blow time of 5 seconds to capture an accurate deep lung sample. The AlcoMate contains a semiconductor oxide sensor designed to test for the presence of alcohol. The AlcoMate semiconductor contains a recently developed ceramic catalytic filter which greatly increases the sensors specificity to alcohol . The AlcoMate sensor uses oxide which has n-type conductivity when exposed to the atmosphere. This exposure causes a decrease in the number of electrons effecting absorbed oxygen molecules and thus increases resistance. If a specific gas (reducing gas) is presented, a reaction occurs with the absorbed oxygen which causes an increase in the electrons in the oxide molecules causing a decrease in resistance. This change in resistance can be measured and used to identify a specific gas (such as alcohol) and can be quantified into a % concentration.
Here's an analysis of the provided text regarding the AlcoMate CA2000 Digital Alcohol Detector's acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (AlcoMate CA2000) |
|---|---|---|
| Indication of Use | Measurement of alcohol in human breath for diagnosis of alcohol intoxication. | SAME |
| Mode | Breath Alcohol Concentration | SAME |
| Practitioner Use | Over the Counter | SAME |
| Measurement Range | 0.00-0.40% | SAME |
| Accuracy | +/- 0.01% (at 0.10% BAC) | +/- 0.01% (at 0.10% BAC) |
| DOT Approval | (Alco-Sensor III) | YES |
Note: The document primarily shows the AlcoMate CA2000's performance as "SAME" as the predicate device, implying it meets the predicate's established performance criteria.
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "bench, DOT, and user testing" and "bench tests, a risk analysis, electrical safety, EMC, DOT testing and user testing data," but without specific numbers or details on the test subjects/data sets.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the given document. The summary focuses on comparing the new device to a predicate device and does not detail the process of establishing ground truth for any testing involving experts. It does mention "DOT testing," which implies adherence to specific standards that would involve calibrated equipment for ground truth, but not human experts in the context of diagnostic interpretation.
4. Adjudication Method for the Test Set
This information is not provided in the given document. Given the nature of a breath alcohol test, adjudication methods involving multiple human readers are not typically applicable. The ground truth would likely be established through calibrated reference instruments.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The device is a standalone diagnostic tool, not an AI assistance tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance evaluation was done. The entire premise of a breathalyzer is its standalone capability to measure alcohol in the breath. The document states:
- "The results of bench, DOT, and user testing indicates that the new device is as safe and effective as the predicate device."
- "After analyzing bench tests, a risk analysis, electrical safety, EMC, DOT testing and user testing data, it is the conclusion of Breathalyzer.net that the AlcoMate CA2000 is as safe and effective as the predicate device..."
These statements indicate that the device itself was tested for its accuracy and effectiveness.
7. The Type of Ground Truth Used
The ground truth for the AlcoMate CA2000's performance would have been established using calibrated reference standards and methods. The document mentions:
- "The relationship between alcohol in the blood and alcohol in the deep lung breath is well established by Henry's law in ratio of 2100:1"
- Its accuracy is stated as "±0.01 % at 0.10% BAC," implying comparison to a known, precise Blood Alcohol Concentration.
- "Calibration: BAC simulator" and "Calibration Interval: 1 year" further confirm the use of a calibrated simulator as the ground truth reference.
- "DOT Approval" generally requires adherence to specific protocols, which involve comparison to known alcohol concentrations in controlled environments.
8. The Sample Size for the Training Set
The document does not mention a training set sample size. This device is a sensor-based system that quantifies a physical property (alcohol concentration) based on established chemical principles and sensor response, rather than a machine learning or AI model that requires a distinct training set in the typical sense. Its "training" would be inherent in the sensor's design and calibration.
9. How the Ground Truth for the Training Set Was Established
Given that this is not an AI/ML device in the modern sense requiring a "training set," this question is not directly applicable. However, if we interpret "training" more broadly as the process of developing and manufacturing the sensor, the ground truth for establishing the sensor's accurate response to alcohol would be based on controlled environments with known concentrations of alcohol and calibrated reference instruments. The mention of "BAC simulator" for calibration points to this method.
§ 862.3050 Breath-alcohol test system.
(a)
Identification. A breath-alcohol test system is a device intened to measure alcohol in the human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.