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510(k) Data Aggregation
(252 days)
The Alco Tube Plus Alcohol Detector is an in vitro medical device to qualitatively detect the presence of alcohol in the human breath. It is a disposable screening device for one-time use. The detector is available in two cut-offs including 0.05 and 0.08 percent breath alcohol. The device is used only as a screening device and is only an indication of the possible presence of alcohol in the blood of the test subject.
The Alco Tube Plus Alcohol Detector (Tester) is a visual qualitative test for the presence of alcohol in human breath. The tester is constituted of glass tubing containing a reagent of yellow crystals that change color when exposed to alcohol vapors. The other part is an opening to blow into while running the test. If alcohol is present, the crystals will change from yellow to green. How many crystals turn color will depend on the cut-off of the Tester and how much alcohol is in the breath. The yellow crystals are coated with Potassium dichromate and sulfuric acid. The amount of these indicator chemicals is adjusted according to the selected cutoff of the Tester. A color change is produced when alcohol vapors are oxidized to acetic acid and the indicator chemicals change to chromium sulfate. The majority of crystals change from yellow to green when alcohol vapors are present at a level equal to or exceeding the cutoff of the Tester. The Alco Tube Plus is available in two cut-offs (0.05%) The cut-off is printed in the instructions and is expressed as a specific percentage of breath alcohol
Here's a breakdown of the acceptance criteria and the study details for the Alco Tube Plus Alcohol Detector, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly state "acceptance criteria" in terms of specific performance metrics that the device must meet (e.g., minimum sensitivity, specificity, or accuracy thresholds). Instead, the study's aim was a "Comparison to Evidentiary Breath Test (Alco-Sensor IV)" and to demonstrate that the device is "as safe and effective as the predicate device." The tables provided show the device's performance against different quantitative breath alcohol levels.
Therefore, the "acceptance criteria" can be inferred as the device demonstrating reliable qualitative detection of alcohol at its specified cut-offs (0.05% and 0.08%) when compared to an evidentiary breath test, with no false positives below these cut-offs and clear positive indications at or above them.
| Metric / Performance Aspect | Acceptance Criteria (Inferred) | Reported Device Performance (0.05% cut-off) | Reported Device Performance (0.08% cut-off) |
|---|---|---|---|
| Qualitative Detection at Cut-off | The device should correctly indicate "positive" when breath alcohol levels are at or above the stated cut-off, and "negative" when below. Specifically, no false positives for levels clearly below the cut-off, and consistent positives for levels clearly above. | Positive Results: - Near cutoff positive (> 0.05 - 0.083%): 70 - Greater than cutoff + 60% (> 0.083%): 21Negative Results: - Less than cutoff - 60% (<0.02%): 80 - Near cutoff negative (0.02 - 0.05%): 29 - Significantly, 0 false positives below the cut-off and 0 false negatives above 0.05 - 0.083%. | Positive Results: - Near cutoff positive (>0.05 – 0.083%): 70 - Greater than cutoff + 60% (> 0.083%): 21Negative Results: - Less than cutoff – 60% (< 0.02%): 80 - Near cutoff negative (0.02 – 0.05%): 29 - Significantly, 0 false positives below the cut-off and 0 false negatives above 0.05 – 0.083%. |
| User Comprehension and Proper Use | Users should be able to read and understand the directions, and properly use the device. | User studies were performed to establish that the user could read and understand the directions provided and properly use the device. The conclusion states: "User studies showed that the over the counter purchaser of this device could read and understand the instructions, could properly use the device and obtain results that were comparable to those of the predicate device." | User studies were performed to establish that the user could read and understand the directions provided and properly use the device. The conclusion states: "User studies showed that the over the counter purchaser of this device could read and understand the instructions, could properly use the device and obtain results that were comparable to those of the predicate device." |
| Comparability to Predicate Device and Evidentiary Test | The device's performance should be comparable to the legally marketed predicate device (BreathScan® Alcohol Detector) and aligned with results from a DOT/NHTSA approved evidentiary breath measurement device (Alco-Sensor IV). | The summary concludes: "the Alco Tube Plus Breath Alcohol Detector is as safe and effective as the predicate device." The data tables show direct comparison to the Alco-Sensor IV. | The summary concludes: "the Alco Tube Plus Breath Alcohol Detector is as safe and effective as the predicate device." The data tables show direct comparison to the Alco-Sensor IV. |
2. Sample Size and Data Provenance for the Test Set
- Sample Size:
- For the 0.05% cut-off tester: n=200
- For the 0.08% cut-off tester: n=200
- Data Provenance: The document does not explicitly state the country of origin. The test was conducted for submission to the FDA in the US, but the company is based in Canada. It's retrospective in the sense that the data is presented from a completed study.
3. Number of Experts and Qualifications for Ground Truth
The document does not specify the number or qualifications of experts used to establish the ground truth. It states that "Testing of the Alco Tube Plus was performed to DOT/NHTSA approved device (Conforming Products List of Evidentiary breath Measurement Devices - FR/Vol. 69, No. 134/July2004/Notices/42237. User studies were performed..." This implies that the ground truth was established by a DOT/NHTSA approved evidential breath test device (Alco-Sensor IV), which is considered a gold standard for quantitative breath alcohol measurement, rather than human experts interpreting results.
4. Adjudication Method for the Test Set
Not applicable. The ground truth was established by an independent, quantitative, and objective evidentiary breath test device (Alco-Sensor IV), not through human expert consensus requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This device is a visual qualitative self-test, not an AI-assisted diagnostic tool that would typically involve human readers. The user studies focused on whether an individual user could understand and properly use the device.
6. Standalone Performance Study
Yes, a standalone performance study was done for the device. The tables provided show the performance of the Alco Tube Plus (with both 0.05% and 0.08% cut-offs) in detecting alcohol against quantitative breath alcohol levels measured by an Alco-Sensor IV, without human interpretation influencing the Alco Tube Plus's color change (though human interpretation is needed to read the result of the Alco Tube Plus). The study effectively demonstrates the device's ability to trigger a color change at specific breath alcohol concentrations.
7. Type of Ground Truth Used
The ground truth used was quantitative breath alcohol measurements obtained from a DOT/NHTSA approved evidentiary breath measurement device, specifically the Alco-Sensor IV. This is an objective and highly accurate method for determining breath alcohol content.
8. Sample Size for the Training Set
The document does not describe a separate "training set" or "training process" as would be typical for machine learning or AI models. This device is a chemical qualitative test, not an algorithm that learns from data. Its "calibration" is inherent in the chemical composition of the crystals adjusted for the desired cut-off.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As noted above, there is no "training set" in the context of this chemical indicator device. The "adjustment according to the selected cutoff" of the indicator chemicals would be based on chemical engineering principles and validated through testing, not through a data-driven training process with established ground truth labels like an AI model.
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