(90 days)
The AL-6000 is intended to measure alcohol in the human breath. Measurements obtained by this device are used in the diagnosis of alcoholic intoxication.
The AL-6000 Breath Alcohol Tester is a screening device for the rapid detection of alcohol in the human breath. Measurements obtained by this device are used in the diagnosis of alcoholic intoxication.
The AL-6000 is a Breath Alcohol Tester designed to measure alcohol in the human breath. The AL-6000 meets or exceeds the requirements of the US DOT (Department of Transportation) and NHTSA (National Highway Traffic Safety Administration). The device takes a breath sample of at least three (3) seconds in order to capture an accurate "deep-lung air" sample. This sample is analyzed by a semiconductor-based gas sensor in order to calculate Breath Alcohol Concentration (BrAC), which is then converted to an equivalent Blood Alcohol Concentration (BAC).
Here's an analysis of the provided text regarding the AL-6000 Breath Alcohol Tester, focusing on acceptance criteria and supporting studies:
It's important to note that the provided document is a 510(k) summary, which is a premarket notification to the FDA. It primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting extensive results from a new, standalone clinical trial. As such, some of the requested information (like detailed training set specifics, MRMC studies, or multi-expert ground truth establishment for this specific device's studies) is not typically included in such a submission.
Description of Acceptance Criteria and Studies
The AL-6000 Breath Alcohol Tester demonstrates its substantial equivalence to the predicate device, AlcoMate CA2000, by meeting similar performance specifications, particularly in measurement accuracy. The primary study proving this equivalence is a "Benchmark and safety testing, EMC/DOT testing and risk analysis, as well as practical user testing." This testing confirmed that the AL-6000 performs within the same ranges of safety and effectiveness as the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Predicate Device) | Reported Device Performance (AL-6000) |
|---|---|
| Measurement Range: 0.00% to 0.40% | Measurement Range: 0.00% to 0.40% |
| Measurement Accuracy: +/-0.01 at 0.10% BAC | Measurement Accuracy: +/-0.01 at 0.10% BAC |
| Sensor Type: Semiconductor oxide sensor | Sensor Type: Semiconductor oxide sensor |
| Certification: DOT / NHTSA | Certification: DOT / NHTSA |
Note: The FDA 510(k) process for this device type primarily focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device. The "acceptance criteria" for the AL-6000 are largely defined by matching or exceeding the performance characteristics of its predicate, the AlcoMate CA2000.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample size used for the test set during the benchmark and practical user testing. It mentions "practical user testing" but provides no further details on the number of subjects or data points.
The data provenance is not specified. It can be inferred that the testing would have been conducted by Sentech Korea Corp., likely in Korea, but this is not explicitly stated. The testing appears to be prospective as it's part of the process to demonstrate equivalence for the AL-6000.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts or their qualifications for establishing ground truth during the testing. Given that this is a breath alcohol tester, the "ground truth" for BAC measurements would typically be established by laboratory-grade reference instruments or blood tests, not necessarily by expert consensus in a subjective interpretation task.
4. Adjudication Method for the Test Set
No adjudication method is described. For devices like breath alcohol testers, the "ground truth" is typically an objective measurement from a highly accurate reference method.
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 or described in this 510(k) summary. MRMC studies are typically performed for imaging or diagnostic interpretation tasks where human readers' performance is being evaluated, often 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
Yes, the core testing described (benchmark and practical user testing of measurement accuracy) represents a standalone assessment of the device's performance. The device directly measures Breath Alcohol Concentration (BrAC) and converts it to Blood Alcohol Concentration (BAC) without "human-in-the-loop" interpretive work as part of its primary function. Its performance is evaluated based on its direct measurements against external standards.
7. The Type of Ground Truth Used
The ground truth for this type of device would typically be:
- Laboratory-grade reference alcohol solutions/simulators: These provide precise, known alcohol concentrations for calibration and accuracy testing.
- Comparison to approved, accurate reference devices: The statement "Benchmark... testing..." implies comparison to established methods or devices with known accuracy.
- Potentially blood alcohol concentration (BAC) measurements: In a clinical validation, human breath alcohol measurements would be correlated with concurrent blood alcohol measurements.
The document states the device "meets or exceeds the requirements of the US DOT (Department of Transportation) and NHTSA (National Highway Traffic Safety Administration)." These organizations have specific protocols for testing breath alcohol devices, which would involve standardized alcohol solutions and direct comparison to a known reference.
8. Sample Size for the Training Set
The document does not mention a specific "training set" or its size. The AL-6000 uses a semiconductor-based gas sensor. While such sensors undergo calibration, the process isn't typically framed as "training" in the same way a machine learning algorithm is trained. The sensor technology has inherent characteristics, and the device's circuitry is designed to interpret sensor output based on established physical and chemical principles, not learned from a data set in the modern AI sense.
9. How the Ground Truth for the Training Set Was Established
Since a "training set" in the context of an AI/ML algorithm isn't described, the ground truth establishment for it is not applicable here. The device relies on the intrinsic properties of its semiconductor sensor and a programmed algorithm to convert sensor readings into BAC. Calibration of the device during manufacturing and periodic checks against known alcohol standards would be part of ensuring its accuracy.
§ 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.