(331 days)
ALCO-SCREEN® is a semi-quantitative screening test used to estimate the Blood Alcohol Concentration (BAC) using human saliva. The test strip estimates BAC at the 0.00%, 0.02%, 0.04%, 0.08% and 0.3% levels. Results are used in the diagnosis of alcohol use or intoxication. For in vitro diagnostic use.
ALCO-SCREEN® is a visually read semi-quantitative test for the detection of alcohol in saliva. The test strip indicates the relative Blood Alcohol Concentration (BAC) at 5 different cut-off levels. The device consists of a box of 24 individually packaged single test strips each designed for single use and to be disposable, and instruction for use.
The Alco-Screen® is a visually read, semi-quantitative test for alcohol detection in saliva, estimating Blood Alcohol Concentration (BAC) at 0.00%, 0.02%, 0.04%, 0.08%, and 0.3% levels.
Here's an analysis of its acceptance criteria and the study proving its performance:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state numerical acceptance criteria in a table format with corresponding reported performance values. Instead, it makes a general statement: "Results demonstrate that Alco-Screen® performs as intended and meets all established specifications."
However, based on the Intended Use and the description of the device's function, we can infer the primary performance characteristic would be its ability to accurately estimate BAC at the specified cut-off levels. The "Performance Testing" section further categorizes the types of studies conducted.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Accuracy of BAC estimation at 0.00%, 0.02%, 0.04%, 0.08%, and 0.3% levels. | "performs as intended and meets all established specifications." |
| Precision and Reproducibility | Studies were conducted to determine these characteristics. |
| Analytical Specificity | Studies were conducted to confirm this characteristic. |
| Stability | Studies were conducted to confirm this characteristic. |
| Field Use Performance | Studies were conducted, demonstrating the device's performance with an evidentiary device. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for any of the performance studies.
Regarding data provenance, the document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. The term "field use studies" suggests prospective data collection in a realistic setting.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not specify the number of experts used to establish ground truth or their qualifications. Given that the device is a visually interpreted chemical test, the "ground truth" would likely be established through comparison with a reference method (e.g., a laboratory-based evidentiary alcohol test).
4. Adjudication Method for the Test Set
The document does not describe any adjudication method (e.g., 2+1, 3+1) for establishing the ground truth of the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted, and therefore, no effect size of human readers improving with AI vs. without AI assistance is available. This device is a visually interpreted chemical test, not an AI-assisted diagnostic tool for interpretation by multiple readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
This question is not applicable to the Alco-Screen®. The device is a visually interpreted chemical test; there is no AI algorithm to evaluate in a standalone manner. The "human-in-the-loop" is always required for visual interpretation against a color chart.
7. Type of Ground Truth Used
While not explicitly stated as "ground truth," the description of "field use studies with an evidentiary device" implies that the device's performance was compared against a reference standard, likely a more accurate and validated method for measuring BAC (e.g., a breathalyzer or blood alcohol test used for legal or medical evidence).
8. Sample Size for the Training Set
The document does not mention a training set sample size. As this is a chemical test interpreted visually against a fixed color chart, it does not involve machine learning or a "training set" in the traditional sense of AI/algorithm development.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no "training set" for this type of device. The performance is assessed against established chemical reaction principles and comparison to reference methods.
§ 862.3040 Alcohol test system.
(a)
Identification. An alcohol test system is a device intented to measure alcohol (e.g., ethanol, methanol, isopropanol, etc.) in human body fluids (e.g., serum, whole blood, and urine). Measurements obtained by this device are used in the diagnosis and treatment of alcohol intoxication and poisoning.(b)
Classification. Class II.