(66 days)
OmegaPoint Systems Personal Breath Alcohol Tester BreathKey™ Model g10 and BreathKey™ Model g30X are indicated for use to measure alcohol in the human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication. BreathKey™ Model g30X transmits the BAC results to an interlock receiver installed in a motor vehicle
The OmegaPoint Systems BreathKey™ Model g10 and BreathKey™ Model g30X Personal Breath Alcohol Testers are designed to measure deep lung air to determine the level of alcohol in the blood. BreathKey™ Model g30X is identical to Model g10 except that Model g30X transmits the Blood Alcohol Content (BAC) results by way of a radio frequency signal to an interlock receiver installed in a motor vehicle.
The alcohol sensor is of the electrochemical fuel cell type. As the user's breath moves through the sensor, the sensor generates an electrical current that is proportional to the concentration of ethanol in the breath.
The OmegaPoint Systems Personal Breath Alcohol Tester (Models g10 and g30X) was evaluated for substantial equivalence primarily through product bench testing against two predicate devices: the AlcoMate CA2000 Digital Alcohol Detector (K041334) and the Intoxilyzer S-D5. The submission also mentions a clinical trial to assess user readability and understandability of the operation manual.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" but rather presents a comparison table that highlights the features and performance characteristics of the OmegaPoint device against its predicates. The "reported device performance" for the OmegaPoint device is assumed to be the values listed in its column. The "accuracy" is the closest direct performance metric mentioned.
| Feature | Acceptance Criteria (from predicate/DOT requirements) | Reported Device Performance (OmegaPoint Models g10 & g30X) |
|---|---|---|
| Accuracy | 0.005% BAC @ up to 0.10% (Intoxilyzer S-D5) AND/OR +/- 0.01% BAC @ 0.10% (AlcoMate CA2000) | +/- 0.0014% BAC @ 0.80% |
| Sensor Type | Electrochemical fuel cell (Intoxilyzer S-D5), Semi-conductor-Oxide Sensor (AlcoMate CA2000) | Electrochemical fuel cell |
| Sampling Time | 4 sec (Intoxilyzer S-D5), 5 sec (AlcoMate CA2000) | 4 sec |
| Warm-up Time | 20 sec (both predicates) | 3 sec |
| Measurement Range | 0.00 - 0.40% (both predicates) | 0.000 - 0.200% |
| Intended User | General Public (AlcoMate CA2000) | General Public |
| Where Used | Home, In public (AlcoMate CA2000) | Home, In public |
| Power Source | 9 Volt Alkaline Battery, replaceable (AlcoMate CA2000), 2 AAA batteries, replaceable (Intoxilyzer S-D5) | 3V lithium battery, permanent |
| Display | 3 Digit LED (both predicates) | 3 Digit and 4 Characters LCD |
| Mouthpiece | Replaceable (both predicates) | Integral |
| DOT Approval | YES (Intoxilyzer S-D5 - implicit from DOT approved device, AlcoMate CA2000 explicitly stated YES) | NO |
Note on Accuracy: The reported accuracy for the OmegaPoint device is given at 0.80% BAC, while the predicates are at 0.10% BAC. Without further context or direct comparison at the same BAC levels, it's difficult to directly compare these accuracy figures. However, the OmegaPoint's stated accuracy of +/- 0.0014% BAC appears to be numerically tighter than the predicates' stated accuracies.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Product bench testing" and a "clinical trial designed to assess user readability and understandability of the Operation Manual."
- Bench Testing: No specific sample size for the bench test is provided. The data provenance is not specified, but it's likely conducted in the US by the manufacturer or a testing lab. The nature of bench testing implies newly generated data (prospective) for the device.
- Clinical Trial for Manual Readability: No sample size is provided for this trial. The data provenance and whether it was retrospective or prospective are not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The ground truth for the bench testing would have been established by calibrated instruments for breath alcohol concentration. For the clinical trial on manual readability, the "ground truth" would likely be subjective user feedback or comprehension scores, not expert consensus on alcohol levels.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The provided text does not describe an adjudication method for measuring BAC or for the manual readability study.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a standalone breath alcohol tester, not an AI-assisted diagnostic tool for "human readers." No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, a standalone performance evaluation was completed. The "Product bench testing" against predicate devices directly assesses the accuracy and other technical specifications of the OmegaPoint device itself. The device is designed for direct consumer use without a "human-in-the-loop" in the sense of interpreting complex diagnostic output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the alcohol measurement aspect, the ground truth would typically be established by:
- Calibrated alcohol-gas mixtures or solutions that simulate known blood alcohol concentrations (for bench testing).
- For in-vivo testing, this would usually be confirmed blood alcohol concentration (BAC) measurements. The document refers to "deep lung air to determine the level of alcohol in the blood," implying the device infers BAC.
For the clinical trial on manual readability, the ground truth would be quantitative or qualitative assessment of user comprehension and ability to follow instructions.
8. The sample size for the training set
Not applicable. The document does not describe the development of an algorithm that would require a "training set" in the context of machine learning. This appears to be a hardware device with an embedded logic, rather than a machine learning model.
9. How the ground truth for the training set was established
Not applicable, 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.