Search Results

This device is intended to measure alcohol in human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.
This devise is intended to measure alcohol in the human breathe. Measurements obtained by this device are use as an aid in the detection of alcohol intoxication.

Protocol's alcohol breath checker is designed to measure deep lung air to test for the presence of alcohol in the blood. Protocol's breath checker is an alcohol screening device and uses a blow time of at least 3 seconds to capture an accurate deep lung sample. Protocol's alcohol breathe tester contains an oxide semiconductor sensor designed to test for the presence of alcohol. The oxide semiconductor material is heated to a specific temperature. The resistance of sensing material changes rapidly according to gas concentration changes, thereby enabling the reading of alcohol concentration by resistance measurement.. The device provides a semi-quantitative measure of a patient's blood alcohol level using colored LEDs as indicators. The indications are: Red & Yellow: BAC 0.08 or more; Yellow: BAC 0.05 to 0.08; Green: BAC < 0.05. The device also includes a flashlight function and a count-up/count-down timer. The timer can be used for parking meter timing or for timing the wait before performing the alcohol test after consuming alcohol, nominally 20 minutes.

The Protocol Alcohol Breath Checker is a breath-alcohol test system designed to measure alcohol in human breath for the diagnosis of alcohol intoxication.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document primarily focuses on demonstrating substantial equivalence to a predicate device (K052448, Connectables Pocket Breathalyzer) rather than explicitly stating acceptance criteria with specific numerical targets. However, based on the comparison provided and the ultimate conclusion, we can infer some key performance aspects being "accepted" as equivalent to the predicate.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The exact sample size for the "clinical trial" is not explicitly stated in the provided documents. The text mentions "user testing" and "a clinical trial was performed" but does not give a number of participants.
• Data Provenance: The document does not specify the country of origin. The study was a "clinical trial," which implies prospective data collection.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Number of Experts: Not applicable in the traditional sense of expert-reviewed images or diagnoses.
• Qualifications of Experts: The ground truth for direct BAC values would have been established by an "evidentiary type of breath alcohol tester" administered by a "trained observer." The specific qualifications of this "trained observer" are not detailed, but it implies a professional certified to operate such devices.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The "ground truth" was established by an independent, professional breath alcohol tester. The Protocol device's readings were then compared to these objective measurements. There was no expert consensus adjudication as is common in image-based AI studies.

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

• No MRMC study was done. This device is a standalone breath alcohol checker and does not involve human readers interpreting results in the same way as, for example, a medical imaging AI. The "clinical trial" focused on the user's ability to operate the device and its comparability to professional instruments, not on augmenting human interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Yes, a standalone study was done. The "clinical trial" evaluated the Protocol Alcohol Breath Checker's performance as a standalone device. Its semi-quantitative readings (Red/Yellow/Green LEDs) were compared directly to the quantitative results from an "evidentiary type of breath alcohol tester." The user interaction involved reading instructions and operating the device, but the device itself produced an output (LEDs) based on its internal algorithm without further human interpretation beyond understanding the LED codes.

7. The Type of Ground Truth Used

• The ground truth used was objective measurements from an "evidentiary type of breath alcohol tester." This can be considered gold- standard instrumentation data for Blood Alcohol Concentration.

8. The Sample Size for the Training Set

• The document does not specify a training set sample size. The information provided is for a 510(k) submission, showcasing the performance of the final device, not details on its development or training if it involved machine learning (which is not indicated for this type of sensor-based device). The "calibration" mentioned for the device itself (using 0.05 and 0.08 BAC solutions in the factory) is a manufacturing step, not a "training set" in the machine learning sense.

9. How the Ground Truth for the Training Set Was Established

• As mentioned above, the concept of a "training set" with ground truth in the machine learning context is not applicable here. The device's underlying sensor technology relies on established physical principles and is calibrated with known alcohol solutions during manufacturing (0.05 and 0.08 BAC solutions). This calibration process ensures the device accurately responds to specific alcohol concentrations.

Ask a specific question about this device