(231 days)
The Mission Saliva Alcohol Test Strip is a screening test used to semi-quantitatively measure alcohol in human saliva. The test strip indicates relative Blood Alcohol Concentration at 0.0%, 0.02%, 0.04%, 0.08%, and 0.30% cut-off levels. Results are used in the diagnosis of alcohol intoxication. For in vitro diagnostic use only.
The Mission Saliva Alcohol Test Strip is a screening test used to semi-quantitatively measure alcohol in human saliva at 0.0%, 0.02%, 0.08%, and 0.30% Blood Alcohol Concentration (BAC). Results are used in the diagnosis of alcohol intoxication. The test is a firm plastic strip with a test pad attached at the tip. The test pad contains chemicals that are highly sensitive to alcohol in saliva reacts with the chemicals to produce a color change on the test pad. The color change depends on the amount of alcohol present. The results are read by comparing the color of the test pad with the color chart. The test gives relative Blood Alcohol Concentration (BAC) from 0.02% to 0.30%.
The Mission Saliva Alcohol Test Strip is a screening test designed to semi-quantitatively measure alcohol in human saliva to assist in the diagnosis of alcohol intoxication.
1. Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" with specific numerical targets. Instead, it discusses the device's characteristics and compares them to a predicate device. The performance of the Mission Saliva Alcohol Test Strip was evaluated through laboratory testing and clinical studies to demonstrate its safety, accuracy, ease-of-use, and substantial equivalence to the predicate device.
Table of Device Characteristics and Intended Measurement Range:
| Feature | Specification / Performance |
|---|---|
| Methodology | Chromogenic reaction |
| Specimen | Saliva |
| Measurement Range | Negative, 0.02%, 0.04%, 0.08%, and 0.30% BAC |
| Measuring Units | BAC % |
| Reading Time | 2 minutes |
| Reading Stability | 3 minutes |
| Storage Temperature | 2-27°C (36-80°F) |
| Shelf Life | 12 months |
| Dimensions | 0.5 x 8.0 cm (0.20 x 3.15 inches) |
| Weight | 0.16 g (0.006 oz) |
| Accuracy (Clinical) | Comparable readings by laypersons and technicians |
| Ease of Use | Satisfied laypersons using Instructions for Use |
2. Sample Size and Data Provenance for the Test Set
- Sample Size: The document does not specify the exact sample size for the clinical study. It only states that "Clinical studies were conducted with laypersons and trained laboratory technicians."
- Data Provenance: Not explicitly stated, but clinical studies were performed in the context of a 510(k) submission to the FDA, implying studies conducted under regulatory guidelines, likely within the US given the submission to the FDA. The study data was compared to an evidentiary breath test, Alco-Sensor IV, a DOT/NHTSA approved device (Conforming Product List of Evidential Breath Alcohol Measurement Devices - FR/Vol 72, No 241/December 2007). The study was likely prospective as it involved evaluating the device's performance in real-time.
3. Number and Qualifications of Experts for Ground Truth
- Number of Experts: Not specified.
- Qualifications of Experts: The ground truth for comparison was established using an "evidentiary breath test, Alco-Sensor IV," which is a "DOT/NHTSA approved device." This reference implies that the Alco-Sensor IV results were considered the "expert" or gold standard, likely operated by trained technicians as mentioned in the clinical study description.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the test set in the traditional sense of multiple human experts reviewing results. The comparison was between the Mission Saliva Alcohol Test Strip (interpreted by laypersons and trained technicians) and the Alco-Sensor IV (operated by trained technicians).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not explicitly described in the provided text. The clinical study aimed to demonstrate that "non-professional, inexperienced laypersons were able to obtain comparable readings when using the Mission Saliva Alcohol Test Strip as compared to the results obtained by the trained technicians." This suggests a comparison of user groups (laypersons vs. trained technicians) with the device, but not a study to evaluate human readers' improvement with AI assistance.
6. Standalone Performance Study
The clinical study described seems to primarily evaluate the standalone performance of the Mission Saliva Alcohol Test Strip. It compares the device's results (whether interpreted by laypersons or trained technicians) directly against an evidentiary breath test device. There is no mention of an "AI" component or human-in-the-loop performance in the context of AI.
7. Type of Ground Truth Used
The ground truth used was established by an objective reference device: an "evidentiary breath test, Alco-Sensor IV," which is a "DOT/NHTSA approved device."
8. Sample Size for the Training Set
The document does not describe separate training and test sets in the typical machine learning context. The studies mentioned (laboratory testing and clinical studies) appear to be for performance evaluation rather than algorithm training. Therefore, the sample size for a "training set" is not applicable or not provided.
9. How Ground Truth for the Training Set Was Established
As there is no mention of a "training set" for an algorithm, these details are not applicable. The context is a diagnostic device that operates based on a chemical reaction, not a machine learning algorithm requiring a training phase with labeled data.
§ 862.3040 Alcohol test system.
(a)
Identification. An alcohol test system is a device intented to measure alcohol (e.g., ethanol, methanol, isopropanol, etc.) in human body fluids (e.g., serum, whole blood, and urine). Measurements obtained by this device are used in the diagnosis and treatment of alcohol intoxication and poisoning.(b)
Classification. Class II.