(115 days)
The Alco-Scan AL-5000 Breath Alcohol Tester is intended to measure alcohol in human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.
AL-5000 is a Breath-alcohol tester designed to measure alcohol in the human breath. And AL-5000 is a D.O.T. approved device and a blow time of 3 seconds is required to capture an accurate deep lung sample. AL-5000 is operated by gas sensor of semi-conductors type for the detection of blood alcohol concentration ( BAC ) from human breath.
The provided text is a 510(k) summary for a breath alcohol tester (AL-5000) seeking substantial equivalence to a predicate device (AlcoMate CA2000). The document focuses on demonstrating similarity in function, technology, and indications for use, rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics.
Therefore, it's not possible to extract all the requested information, particularly regarding specific numerical acceptance criteria, detailed study design with sample sizes for test/training sets, expert qualifications, or multi-reader studies. The document primarily relies on engineering and performance characteristics comparison to a predicate device.
Here's an attempt to answer the questions based only on the provided text, highlighting what is available and what is not:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a numerical or statistical sense for a clinical study. Instead, it demonstrates equivalence to a predicate device. The performance is implied to be similar to the predicate device, which is "DOT approved".
| Characteristic | Predicate Device (AlcoMate CA2000) Performance | AL-5000 Reported Performance | Acceptance Criteria (Implied for Equivalence) |
|---|---|---|---|
| Indication of use | "The device is intended to measure alcohol in the human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication." | Same | Same as predicate device's intended use. |
| Measure range | 0.00-0.10% BAC | Same | 0.00-0.10% BAC |
| Warm up time | Below 20 seconds | Below 21 seconds | Comparability to predicate device. |
| DOT approval | Yes | Yes | DOT approval |
| Electrical Safety, EMC | (Implied safe and effective) | Passed | Safe and effective (as predicate). |
| Technological Differences | Few minor differences (e.g., power source, mouthpiece, size, weight) | Few minor differences | No new indications for use; as safe & effective as predicate. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. No specific clinical test set, sample size, or data provenance (country, retrospective/prospective) is described. The assessment appears to be based on technical evaluations, not human participant data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided as there is no description of a clinical test set requiring expert ground truth.
4. Adjudication Method for the Test Set
This information is not provided as there is no description of a clinical test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a MRMC study was not done. Human-in-the-loop performance or comparison of human readers with/without AI assistance is not relevant to this device, which is a standalone breath alcohol tester.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The AL-5000 is a standalone device in its function (measuring breath alcohol). The provided text describes its technical operational principles (gas sensor, semi-conductor type, detecting BAC from human breath) and how it achieves its measurement. The "study" mentioned is not a clinical performance study on human subjects but rather "electrical safety, EMC and DOT tests" to demonstrate that it is "as safe and effective as the predicate device."
7. The Type of Ground Truth Used
For the specific "tests" mentioned (electrical safety, EMC, DOT), the ground truth would be established by the respective regulatory and testing standards for those areas. For blood alcohol concentration measurement, the implied ground truth for the device's accuracy would typically be laboratory-confirmed blood alcohol levels, but this is not explicitly stated in the document for the AL-5000's performance validation. The document relies on functional equivalence to a DOT-approved predicate.
8. The Sample Size for the Training Set
This information is not provided. The device does not appear to utilize machine learning or AI that would require a "training set" in the typical sense for medical imaging or diagnostic algorithms.
9. How the Ground Truth for the Training Set Was Established
This information is not provided as there is no mention of a training set.
§ 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.