(151 days)
This device is intended to measure alcohol in the human breath. Measurements obtained by this device are used as an aid in the detection of alcohol intoxication.
The BACTRACK™ Breathalyzer is designed to measure deep lung air to test for the presence of alcohol in the blood. The relationship between alcohol in the blood and alcohol in the deep lung breath is well established by Henry's law in ratio of 2100:1 The BACTRACK™ Breathalyzer is has been tested and uses a blow time of 5 seconds to capture an accurate deep lung sample. The BACTRACK™ Breathalyzer sensor uses tin dioxide which has n-type conductivity when exposed to the atmosphere. This exposure causes a decrease in the number of electrons effecting absorbed oxygen molecules and thus increases resistance. If a specific gas (reducing gas) is presented, a reaction occurs with the absorbed oxygen which causes an increase in the electrons in the oxide molecules causing a decrease in resistance. This change in resistance can be measured and used to identify a specific gas (such as alcohol) and can be quantified into a % concentration.
The K071067 submission describes the BACTRACK™ Breathalyzer Digital Alcohol Detector.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature | Acceptance Criteria (Predicate Device K041334) | Reported Device Performance (BACTRACK™ Breathalyzer) |
|---|---|---|
| Measurement Range | .00-.40% | .00-.40% |
| Accuracy | +/-0.01% | +/-0.01% |
2. Sample Size Used for the Test Set and Data Provenance
The submission mentions "user testing data" and a "clinical trial" but does not specify the sample size for these tests.
The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin mentioned. However, the nature of a "clinical trial" and "user testing" generally implies a prospective data collection, likely in the country where the manufacturer operates or seeks approval.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The submission states that the clinical trial aimed to: "perform comparably to an evidentiary type of breath alcohol tester." and "obtain results that were comparable to those provided by a professional unit administered by a trained observer."
This implies that the ground truth for the clinical trial was established by an "evidentiary type of breath alcohol tester" operated by a "trained observer." The number of such "observers" or "professional units" is not specified. The qualifications of these observers are limited to "trained," without further detail (e.g., years of experience, specific certifications).
4. Adjudication Method for the Test Set
The submission does not explicitly describe an adjudication method for the test set. The comparison appears to be directly against the "evidentiary type of breath alcohol tester" or "professional unit."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described focuses on comparing the BACTRACK™ Breathalyzer's performance against a "professional unit" and user's ability to operate the device, not on assessing multiple human readers or the effect of AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
Yes, a standalone performance evaluation was done in the sense that the device's accuracy was assessed independently against a reference standard. The "bench tests" and the comparison of the BACTRACK™ Breathalyzer's readings to an "evidentiary type of breath alcohol tester" represent a standalone evaluation of the device's core functionality.
7. The Type of Ground Truth Used
The ground truth used for performance validation was the measurement from an "evidentiary type of breath alcohol tester" or "professional unit." This implies a reference standard that is generally accepted as accurate for breath alcohol measurement.
8. The Sample Size for the Training Set
The submission does not mention a training set or its sample size. The BACTRACK™ Breathalyzer uses a semiconductor-oxide sensor, which suggests a physical-chemical principle of operation rather than a machine learning algorithm that typically requires a training set.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a training set for machine learning, there is no information provided on how ground truth for a training set was established.
§ 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.