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The Alco-Breath Tube is a device to test for alcohol in human breath. It is a disposable device designed for one-time use and is a screening test that gives preliminary results. This device provides a semi-quantitative estimate of alcohol levels in breath. The ABT-08 device gives readings between 0 and 0.08% BAC and the ABT-15 device gives readings between 0 and 0.15% BAC.

The CheckPoint breath alcohol test is a device to test for alcohol in human breath. It is a disposable device designed for one-time use and is a screening test that gives preliminary results. The test is available at cut-offs of 0.02, 0.04, 0.05, and 0.08% BAC.

The Alco-Breath Tube is a disposable, one-time use in vitro diagnostic (IVD) device using a length-of-stain method to give estimates of alcohol concentrations. A chemical reaction occurs when the reagent-treated silica gel is exposed to breath alcohol at or greater than the threshold level of the test device. The results are interpreted based on the observation of a color change within a specified period of test time. The color change is proportional to the concentration of alcohol in the breath. The device provides preliminary screening test results and is not intended to be used as evidential results.

The Alco-Breath Tube is intended to detect the presence of alcohol in the breath at concentrations between 0.02 BrAC (Breath Alcohol Concentration) and 0.08 or 0.15 BrAC. The Alco-Breath Tube is intended for screening in medical and therapeutic programs. This product will also give a semi-quantitative estimate of alcohol levels in these ranges. The Alco-Breath Tube is a disposable device designed for one-time use.

The CheckPoint® Breath Alcohol Test is a disposable, one-time use in vitro diagnostic (IVD) device using a color change to indicate the presence of alcohol. A chemical reaction occurs when the reagent-treated silica gel is exposed to breath alcohol at or greater than the threshold level of the test device. The results are interpreted based on the observation of a color change within a specified period of test time. The device provides preliminary screening test results and is not intended to be used as evidential results.

The CheckPoint® Breath Alcohol Test is intended to detect the presence of alcohol in the breath at a concentration of 0.02% or greater. The CheckPoint® comes in four different alcohol levels: 0.02%. 0.04%. 0.05%. and 0.08%. The alcohol level for each device is printed on the label of the device. The CheckPoint® Breath Alcohol Test are a disposable device designed for one-time use and is intended for screening in medical and therapeutic programs.

The Alco-Breath Tube and CheckPoint® Breath Alcohol Test are intended to detect the presence of alcohol in breath. The summary provides details on the performance evaluation studies conducted and the standards followed.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document references "Performance Specifications" and lists several analytical performance tests, but it does not explicitly state quantitative acceptance criteria or corresponding reported device performance values in a table format. It only lists the types of tests conducted:

The document states: "The conduct of performance evaluation studies is based on the most current National Highway Traffic Safety Administration (NHTSA)/ DOT guidance document. 'Highway Safety Programs; Model Specifications for Screening; Devices to Measure Alcohol in Bodily Fluids'." This implies that the acceptance criteria are derived from this guidance, but the concrete thresholds are not explicitly stated in this document.

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "performance evaluation studies" and "usability tests" but does not quantify the number of samples or participants.
• Data Provenance: Not explicitly stated. The document refers to NHTSA/DOT guidance, which is a national standard for alcohol screening devices in the US, suggesting the data would likely be from studies conducted within the US, but this is not definite. It also doesn't specify if the studies were retrospective or prospective.

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

Not explicitly stated. The document does not mention the use of experts for establishing ground truth, nor their number or qualifications. The comparative effectiveness study is referenced in the context of the device's performance against established standards, not against expert consensus.

4. Adjudication Method for the Test Set:

Not applicable/Not explicitly stated. The document does not describe an adjudication method. The device provides "preliminary screening test results" based on a visual color change in a chemical reaction. The interpretation is based on observation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Was it done? No. The document does not describe a MRMC comparative effectiveness study where human readers improve with AI vs. without AI assistance. The device itself is a standalone, single-user chemical test with visual interpretation, not an AI-assisted diagnostic tool for human readers.
• Effect size of human readers improving with AI vs. without AI assistance: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Yes, in essence. The Alco-Breath Tube and CheckPoint® Breath Alcohol Test are described as "disposable, one-time use in vitro diagnostic (IVD) device[s] using a length-of-stain method to give estimates of alcohol concentrations" or "using a color change to indicate the presence of alcohol." The "device provides preliminary screening test results and is not intended to be used as evidential results." The mechanism is a chemical reaction with visual interpretation by the user, making it a standalone test where the device's chemical reaction (analogous to an algorithm in this context) directly produces the result for human interpretation. The "usability tests were conducted to determine if consumers can correctly perform and interpret tests according to the package insert," which suggests a human-in-the-loop component for interpretation, but the core "algorithm" (chemical reaction) is standalone.

7. Type of Ground Truth Used:

The ground truth for the performance evaluation studies (Precision/Reproducibility, Detection Limit, Analytical Specificity, Comparison Studies) is implicitly based on reference alcohol concentrations used in laboratory settings, as dictated by the NHTSA/DOT guidance mentioned. The comparison studies would involve comparing the device's results against established methods of measuring alcohol concentration to verify accuracy.

8. Sample Size for the Training Set:

Not applicable. This device is a chemical screening test, not a machine learning or AI algorithm that requires a training set in the conventional sense.

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

Not applicable. As this is not a machine learning model, there is no training set or associated ground truth establishment process for a training set.

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