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510(k) Data Aggregation
(263 days)
PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM
The PAD Breath Alcohol Tester is a screening device for the rapid detection of alcohol in the human breath. Measurements obtained by this device are used in the diagnosis of alcoholic intoxication.
The PAD is a self-contained unit with 3 digit LCD display, and power button. The 3 digit LCD display window displays the alcohol concentration in increment of 0.01%. The display is also capable of displaying L-b, S-E, t-F, L-t, n-C, HI and these states low battery, sensor error, test fail, low temperature, need calibration , high concentration, respectively. The unit is powered by two AAA batteries.
Acceptance Criteria and Device Performance Study for PAD (Personal Alcohol Detector)
This document outlines the acceptance criteria and the study conducted to demonstrate that the PAD (Personal Alcohol Detector) device meets these criteria.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Measurement Accuracy | ±0.01 at 0.10%BAC |
| Accuracy established at 0.008% and 0.032% BAC | |
| Warm-up Time | About 20 seconds (Specification: Less than 1 minute) |
| Testing Capacity | Approx. 800 (on 2 batteries) |
| Measurement Range | 0.00% to 0.20% BAC |
| Operating Temperature | 10°C (50°F) to 40°C (104°F) |
Note: The provided document states "Accuracy at a Blood Alcohol Concentration greater than 0.032% has not been established," which is an important limitation to note regarding the scope of established accuracy.
2. Sample Size Used for the Test Set and Data Provenance
The document states that a "clinical trial was performed to establish that the user could read and understand the instructions provided, and properly use the device. as well as perform comparably to an evidentiary type of breath alcohol tester."
- Sample Size: The exact sample size for the "user testing" and "clinical trial" is not specified in the provided text.
- Data Provenance: The country of origin of the data is not explicitly stated. Given that the submitter is "SEJU Engineering Co., Ltd." from "Republic of Korea" and the 510(k) summary is addressed to the "Food and Drug Administration," it is plausible the study was conducted to meet FDA requirements, potentially involving data from various sources. The study is described as a "clinical trial," implying it was prospective in nature for this device.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- The document mentions that the clinical trial aimed to "perform comparably to an evidentiary type of breath alcohol tester." This implies that the ground truth for alcohol concentration was established using an "evidentiary type of breath alcohol tester," which is typically a highly accurate and calibrated device used by trained professionals (e.g., law enforcement or medical personnel).
- The number of experts or specific qualifications of those operating the evidentiary breath alcohol tester is not specified in the provided text. However, "evidentiary type" implies professional operation and established protocols for accuracy and calibration.
4. Adjudication Method
The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for the test set. The comparison was made against "an evidentiary type of breath alcohol tester," suggesting a direct comparison of results rather than a consensus-based adjudication process for human interpretation of results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not explicitly performed or described in the provided text. The study focused on demonstrating that "the user could read and understand the instructions provided, and properly use the device, as well as perform comparably to an evidentiary type of breath alcohol tester." This implies assessing user interface and device performance against a gold standard, not a comparison of human reader performance with and without AI assistance. The device itself is a standalone measurement tool, not an AI-assisted diagnostic aid for human interpretation.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study was implicitly done as the core of the clinical trial was to assess the device's ability to "perform comparably to an evidentiary type of breath alcohol tester." The device produces a direct numerical output (BAC) based on its sensor and algorithm, without human interpretation as part of the primary result. The section on "Measurement Accuracy" with a tolerance of "±0.01 at 0.10%BAC" is a measure of standalone performance.
7. Type of Ground Truth Used
The ground truth used was based on measurements from an "evidentiary type of breath alcohol tester." This type of device is considered a gold standard for measuring Blood Alcohol Concentration (BAC) from breath samples, providing objective, quantitative data.
8. Sample Size for the Training Set
The document does not specify a separate training set or its sample size. For a traditional breath-alcohol tester, "training" often refers to the calibration and internal development/testing of the sensor and algorithms by the manufacturer, rather than a distinct "training set" of patient data in the way an AI/ML model would use it.
9. How the Ground Truth for the Training Set was Established
As no separate training set is explicitly mentioned, the method for establishing ground truth for a training set is not described. The device's performance relies on its sensor technology and internal calibration, which would typically be validated against known alcohol concentrations or reference devices during the manufacturing and quality control process.
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