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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.

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.

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The ALCO-SCREEN® 02 is a qualitative screening test used to detect the presence of ethyl alcohol in human saliva. The test detects relative Blood Alcohol Concentrations (BAC) greater than or equal to 0.02%. Results are used for the diagnosis of alcohol intoxication. For in vitro diagnostic use. The assay is a disposable test for one-time use.

ALCO-SCREEN® 02 is a visually read qualitative test for the detection of alcohol using saliva. The test strip indicates the relative Blood Alcohol Concentration (BAC) at 0.02%. 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.

Here's an analysis of the provided text regarding the Alco-Screen® 02 device's acceptance criteria and studies:

Acceptance Criteria and Device Performance

The provided text does not explicitly state quantitative acceptance criteria in a table format with specific metrics. However, it does indicate the device's intended performance.

Study Details

Based on the provided information, the description of the studies is quite limited.

• Sample size used for the test set and the data provenance: Not explicitly stated. The document mentions "field use studies with an evidentiary device" but does not provide details on sample size, country of origin, or whether the study was retrospective or prospective.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not explicitly stated.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. The device is a visually read qualitative test, not an AI-assisted diagnostic. There is no mention of human readers' performance improvement with or without AI assistance.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The device itself is a standalone test strip for visual interpretation. There is no algorithm involved in its direct interpretation; a human visually reads the color change.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated how the "true" BAC levels were determined for the performance tests. Given the nature of a BAC test, it's highly probable that a referencemethod (e.g., blood alcohol analysis or a calibrated breathalyzer) would be used as the ground truth.
• The sample size for the training set: Not applicable. This device is a chemical test strip, not an AI algorithm that requires a training set.
• How the ground truth for the training set was established: Not applicable, as there is no training set for this type of device.

Summary of "Performance Testing" Section:

The document states:

"The performance characteristics of Alco-Screen® 02 were determined by conducting precision and reproducibility studies, analytical specificity studies, stability studies, and field use studies with an evidentiary device. Results demonstrate that Alco-Screen® performs as intended and meets all established specifications."

This paragraph briefly outlines the types of studies conducted but provides no quantitative results, sample sizes, methodology details, or specifics about the "evidentiary device" used in field studies. The "established specifications" are not detailed in the provided text.

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