(80 days)
The Breath Alcohol Z .02 Detection System and BreathScan® .02 Breath Alcohol Detection System are in vitro medical devices that qualitatively detect the presence of alcohol in the human breath. The test system detects equal to or greater than 0.02 percent breath alcohol. The system 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 Breath Alcohol 70 .02 Detection System and BreathScan® .02 Breath Alcohol Detection System are a visual qualitative test for alcohol in the human breath. The Breath Alcohol 20 .02 Detection System and BreathScan® .02 Breath Alcohol Detection System consist of a self-contained electronic analyzer to qualitatively detect the presence of alcohol in the human breath. It is a reusable device designed for use with a specific lot of Breath Alcohol Z . 02 or BreathScan® .02 Detectors. The detectors are disposable screening devices designed for one time use. The Breath Alcohol .02 and BreathScan .02 Electronic Analyzers enable the user to read or interpret their Breath Alcohol 70 .02 or BreathScan® .02 Detectors charged by human breath. The system provides an indication of the possible presence of alcohol in the blood of the test subject.
The detectors contains chemicals that change color in the presence of alcohol vapors) utilizing the patented technology (US Patent No. 4,740,475). The Detector consists of two parts. One part is a glass capsule containing light yellow crystals that change color when exposed to alcohol vapors. The other part is a plugged, plastic tube with an opening to blow into while running the test.
If alcohol is present. the crystals will change from yellow to light green/blue. How many crystals turn color will depend on the cut-off of the Detector and how much alcohol is in the breath.
The yellow crystals in the Detector are coated with potassium dichromate (K2Cr2O7) and sulfuric acid (H2SO4). The amount of these indicator chemicals is adjusted according to the selected cutoff of the Detector. A color change is produced when alcohol vapors are oxidized to acetic acid and the indicator chemicals change to chromium suffate [Cr2(SO4)3]. The majority of crystals change from yellow to light aqua (greenish-blue/bluish-green) when alcohol vapors are present at a level equal to or exceeding the cutoff of the Detector.
The blow bags are re-usable and serve as a method to assure that the subject has blown through the Detector with adequate air. With the Breath Alcohol . 02 Detection System, this is required (DOT/NHTSA compliance) and is listed as an option in the BreathScan® .02 Breath Alcohol Detection System.
The Breath Alcohol Z .02 and BreathScan® .02 Electronic Analyzers are selfcontained, sealed devices where the Breath Alcohol or BreathScan® Detector charged with human breath is inserted into the device to begin the reading process. The internal make-up of the Electronic Analyzer is the same for both models. The only difference is how the detector is positioned or inserted into the device. Using the Breath Alcohol .02 Detection System, the detector is inserted into a sample port; whereas using the BreathScan® .02 Breath Alcohol Detection System, the detector is placed in a nested holder.
The Electronic Analyzer automatically turns on and the lights will flash instantaneously, indicating the respective result. The device comes pre-calibrated to the user for the cut-off sensitivity of the Breath Alcohol 700.02 or BreathScan® .02 Detector lot being "read" in the analyzer. A negative result is indicated by a continuously flashing green LED and a positive result is indicated by a continuously flashing red LED.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
The provided document describes the device's performance against two main types of criteria: comparison to an evidentiary breath test and compliance with DOT/NHTSA guidelines. The tables below summarize the device performance against the stated categories.
Detection System: Breath Alcohol 70 .02 Detection System and BreathScan® .02 Breath Alcohol Detection System
| Acceptance Criteria Category | Specific Criteria/Reference | Reported Device Performance | Comments |
|---|---|---|---|
| Comparison to Evidentiary Breath Test (Alco-Sensor IV) | Less than 60% below the Cutoff (0.020% to 0.032%) | Positive: 8 | |
| Negative: 0 | Device correctly identified all cases in this range as positive. | ||
| High Positive (>0.032%) | Positive: 11 | ||
| Negative: 0 | Device correctly identified all cases in this range as positive. | ||
| DOT/NHTSA Guidelines Compliance | Model Specifications for Alcohol Screening Devices (Federal Register/Vol. 59, No. 147, August 2, 1994/Notices/39382) | "evaluated and found to meet the guidelines" | The document states that the devices met these guidelines, but specific performance metrics against these guidelines are not provided in this summary. |
| User Understanding and Proper Use | User could read and understand directions and properly use the devices. | User studies were performed to establish this. | The text mentions user studies were performed to establish this, implying this criterion was met, but no specific data or metrics are provided. |
Study Details
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Sample Size Used for the Test Set and Data Provenance:
- Sample Size:
- For the Breath Alcohol ® .02 Detection System: 22 + 3 + 8 + 11 = 44 cases
- For the BreathScan® .02 Breath Alcohol Detection System: 22 + 3 + 8 + 11 = 44 cases
- It appears to be the same set of 44 cases for both devices, as the performance numbers are identical in Table 1 and Table 2.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It describes "bench test and user testing data," which typically implies a prospective study conducted specifically for validation.
- Sample Size:
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- The ground truth was established by comparison to an "Evidentiary Breath Test (Alco-Sensor IV)," which is described as a "DOT/NHTSA approved device." This reference device acts as the "gold standard" or ground truth. The study does not mention human experts establishing ground truth for the alcohol levels themselves, but rather relies on the measurement from the Alco-Sensor IV.
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Adjudication Method for the Test Set:
- No adjudication method is mentioned in the context of resolving discrepancies between multiple readers or ground truth. The comparison is directly between the investigational device's reading and the "Evidentiary Breath Test" (Alco-Sensor IV) result.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done. This device is a standalone detection system, not an AI-assisted diagnostic tool for human interpretation.
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Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Yes, the performance presented in Tables 1 and 2 appears to be a standalone (algorithm only) performance. The "Electronic Analyzer" automatically turns on and the lights flash indicating the result ("continuously flashing green LED" for negative, "continuously flashing red LED" for positive). There is no mention of human interpretation influencing the final reported result from the device itself for these comparison tests. User studies were performed to ensure proper device use, but the device's output is automatic.
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Type of Ground Truth Used:
- The ground truth used was comparison to a reference device, specifically the "Evidentiary Breath Test (Alco-Sensor IV)." The Alco-Sensor IV is considered a "DOT/NHTSA approved device," implying it is a validated and accepted method for determining breath alcohol concentration.
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Sample Size for the Training Set:
- The document does not provide information regarding a separate training set or its sample size. This type of device, based on a chemical reaction read by an electronic analyzer, typically undergoes calibration during manufacturing rather than machine learning training. The device "comes pre-calibrated... for the cut-off sensitivity."
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How the Ground Truth for the Training Set Was Established:
- As no training set is explicitly mentioned in the provided text for a machine learning context, the method for establishing its ground truth is not applicable or not provided. The device's calibration is mentioned, which would involve setting its sensitivity against known alcohol standards.
§ 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.