(147 days)
The BreathScan PRO is an in vitro medical device that quantitatively detects the presence of alcohol in the human breath. The system is used only as a screening device and is an indication of the presence of alcohol in the blood of the test subject.
The BreathScan PRO is quantitative screening test for alcohol in the human breath and provides a digital readout. The BreathScan PRO consists of a selfcontained electronic analyzer to quantitatively detect the presence of alcohol in the human breath. The detection level range is from 0.00% to 0.15%. Breath Alcohol concentrations higher than 0.15% will be displayed as BAC >0.15%. The electronic Analyzer is factory pre-calibrated and is ready to use when a Detector is fully inserted into the sample port. It is a re-usable device designed for use specifically with BreathScan®PRO detectors.
The detectors are disposable screening devices designed for one time use. The BreathScan®PRO Electronic Analyzer enables the user to read or interpret their BreathScan PRO 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. 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.
When the subject exhales into the tube, the fresh crystals interact with breath vapor and change color from yellow to blue green if alcohol is present. Note: The resulting color change is dependent upon the level of alcohol detected.
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 BreathScan PRO. this is required (DOT/NHTSA compliance). ABI provides these in the starter kit and as an option for future orders.
Here's an analysis of the provided information regarding the BreathScan®PRO device, focusing on acceptance criteria and the supporting study:
1. Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state specific quantitative acceptance criteria for parameters like accuracy, precision, or false positive/negative rates prior to presenting the study results. Instead, it implies a comparison to a predicate device (Breath Alcohol .02 Detection System K062971) and an evidentiary breath test (ALCO SENSOR IV).
However, the study results themselves can be interpreted as demonstrating the device's performance against an implicit standard set by the comparator device. The document also mentions meeting DOT/NHTSA guidelines as an acceptance benchmark.
Implicit Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Quantitative Correlation with Evidentiary Breath Test | Correlation: The scatter plot (Image /page/2/Figure/1) shows a regression line of y = 0.8579x + 0.0042 with an R-squared value of 0.8447 when comparing the BreathScan®PRO (BSPro) to an Evidentiary Breath Test (Alco-Sensor IV). |
| Standard Error: 0.01 | |
| Compliance with DOT/NHTSA Model Specifications | The BreathScan®PRO was evaluated and found to meet the guidelines provided in the DOT/NHTSA Model Specifications for Alcohol Screening Devices (Federal Register/Vol. 73, No. 62, March 31, 2008/Notices/16956). (Specific performance metrics against these guidelines are not provided in this document). |
| Equivalence to Predicate Device (Breath Alcohol .02 Detection System K062971) | Indications for Use: Both detect alcohol in human breath. |
| Target Populations: Both Over the Counter. | |
| Result Type: Predicate is qualitative (Red/Green LEDs), BreathScan®PRO is quantitative (digital readout). This is a difference, not a direct performance comparison, but implies the BreathScan®PRO offers a more detailed result. | |
| Accuracy/Calibration: Neither requires calibration. | |
| Other differences: Measurement range, display type, physical characteristics, power source, battery life (BreathScan®PRO has longer battery life). These are characteristics, not direct performance metrics of accuracy or precision. | |
| Safe and Effective as an Evidentiary Breath Test | Bench test and user testing data indicated the BreathScan®PRO is safe and effective as an evidentiary breath test. |
| User Comprehension and Proper Use | User studies were performed to establish that the user could read and understand the directions provided and properly use the devices, obtaining results comparable to a predicate device administered by a trained technician. (Specific metrics for user comprehension are not provided in this document). |
Study that Proves the Device Meets the (Implicit) Acceptance Criteria:
The key study presented is a comparison of the BreathScan®PRO against the ALCO SENSOR IV, which is described as an "Evidentiary Breath Test" and a "DOT/NHTSA approved device."
The study is described as:
- Bench test and user testing data for safety and effectiveness.
- A comparison to the Evidentiary Breath Test (Alco-Sensor IV), the results of which are depicted in the scatter plot.
- User studies to assess user comprehension and proper usage, obtaining comparable results to a predicate device.
2. Sample Size and Data Provenance
- Test Set Sample Size: 62 total subjects were used for the comparison study with the Alco-Sensor IV.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study appears to be prospective as it involves user testing and data collection for comparison.
3. Number of Experts and Qualifications for Ground Truth
- The document mentions comparison to the ALCO SENSOR IV, which is an "Evidentiary Breath Test" and a "DOT/NHTSA approved device." The results from this device are essentially considered the ground truth for the quantitative comparison.
- It also states that user studies obtained results "comparable to those provided by a predicate device administered by a trained technician." While not directly defining the ground truth for measurement, this implies the benchmark performance of the predicate device under expert operation.
- The number of "experts" (or trained technicians operating the Alco-Sensor IV) is not specified. Their specific qualifications (e.g., years of experience) are also not specified beyond "trained technician."
4. Adjudication Method
- The document does not describe an adjudication method (e.g., 2+1, 3+1) for establishing ground truth. The Alco-Sensor IV appears to be the single source of ground truth for BAC measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not explicitly mentioned or performed in the provided text. The study focuses on comparing the device's readings to an evidentiary breath test and assessing user performance, not on how human readers' diagnostic accuracy improves with or without AI assistance. The BreathScan®PRO is a standalone device with a digital readout, not an AI-assisted diagnostic tool for human interpretation.
6. Standalone Performance Study
- Yes, a standalone performance study was done. The core "bench test" and "user testing data" with the comparison to the Alco-Sensor IV evaluates the algorithm's (device's) performance in generating the quantitative digital readout of BAC. The digital readout is inherently the algorithm's output.
7. Type of Ground Truth Used
- The primary ground truth used for quantitative comparison was the readout from a legally recognized evidentiary breath test device (ALCO SENSOR IV). This is a form of device-based ground truth using a gold-standard instrument.
- For the user studies, the ground truth was implied to be the results obtained by a trained technician operating a predicate device, which served as the benchmark for comparison of user-obtained results.
8. Sample Size for the Training Set
- The document does not specify the sample size for a training set. This is a device for detecting alcohol in breath, not typically an AI/ML model that undergoes a distinct training phase in the same way. The device is factory pre-calibrated.
9. How Ground Truth for the Training Set Was Established
- As a factory pre-calibrated device rather than a machine learning model, the concept of a "training set" and establishing ground truth for it in the typical AI context does not apply directly. The document states the electronic Analyzer is "factory pre-calibrated." The methods for this pre-calibration and the ground truth used during that calibration are not detailed in the provided text.
§ 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.