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This device is intended to measure alcohol in human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.

The BACTRACK® Select Breathalyzer is an alcohol screening device, used for the detection of alcohol in the breath. The BACTRACK® provides a digital result, indicating the approximate BAC (Blood Alcohol Content) of the test subject. The BACTRACK® is powered by two AA batteries and is very easy to use. The device employs a fuel cell sensor of the same type commonly used in evidentiary breathalyzers. This results in generally better accuracy and longer battery life than silicon sensor units. The units are factory calibrated but the product should be recalibrated at least every six to twelve months. If the product is used every day, it may need to be recalibrated as frequently as every month.

The provided text describes the 510(k) premarket notification for the Bactrack® Select Breathalyzer Model S80. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and comprehensive performance data.

However, based on the available information, I can extract the following:

1. Table of Acceptance Criteria and Reported Device Performance

The device claims to meet the performance of the predicate device, the AlcoHAWK PT500. Therefore, the predicate's performance serves as an implicit acceptance criterion.

Note on Accuracy: The accuracy specification for the Bactrack® Select Breathalyzer is shown as "C +/- 0.01 %BAC @ 0.02 %BAC" while the predicate's is "± 0.01% BAC at 0.10% BAC". This implies the Bactrack® specifies its accuracy at a lower BAC level (0.02% BAC) compared to the predicate (0.10% BAC) while maintaining the same absolute tolerance of ±0.01% BAC. Without further context or test results, it's difficult to directly compare these as equivalent or superior/inferior at all BAC levels. However, in the context of a 510(k), meeting or exceeding predicate performance is generally expected. The text states "few technological differences" and "as safe and effective," suggesting this difference in accuracy specification is considered acceptable for substantial equivalence.

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

The document mentions "clinical testing data" and a "clinical trial performed." However, no specific sample size (number of subjects or tests) for this clinical trial is provided.

The data provenance is not explicitly stated (e.g., country of origin). The submission is to the US FDA, so it's likely US-based, but this is an assumption. The data is prospective, as it describes a clinical trial that was "performed."

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

This information is not provided in the document. The text only states that the clinical trial showed "obtain results that were comparable to those provided by a professional unit administered by a trained observer." It does not specify the qualifications of this "trained observer" or if multiple experts were involved in establishing ground truth for the device accuracy itself.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method for the test set.

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

An MRMC comparative effectiveness study was not done. This device is a breathalyzer, not an AI-assisted diagnostic tool for human readers. The clinical trial focused on the ability of an "over the counter purchaser" to use the device and obtain comparable results to a "professional unit administered by a trained observer."

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, the primary evaluation of this device is in a standalone capacity. The device itself (the "algorithm only," in this context, referring to its measurement mechanism) is being assessed for its ability to accurately measure alcohol in breath. The clinical trial additionally assessed the human factor of the "over the counter purchaser" correctly using the device, but the core performance is the device's standalone measurement.

7. The Type of Ground Truth Used

The ground truth for the clinical trial appears to be established by comparison to "a professional unit administered by a trained observer." This implies a reference standard or a "gold standard" breathalyzer, likely a more sophisticated evidentiary or clinical device, against which the performance of the BACTRACK® Select Breathalyzer was compared.

8. The Sample Size for the Training Set

The document does not refer to a "training set." This type of device (a breathalyzer) typically undergoes calibration during manufacturing and recalibration at specified intervals, but it is not a machine learning or AI-driven system that would have a conventional "training set" in the context of data-driven algorithm development.

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

As there is no mention of a "training set" in the context of algorithm development, this information is not applicable. The device is factory calibrated, and recalibration is recommended, implying a process of adjusting the device against known alcohol concentrations, but this isn't a "training set" in the AI sense.

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This device is intended to measure alcohol in human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.

The BACTRACK® Select Breathalyzer is an alcohol screening device, used for the detection of alcohol in the breath. The BACTRACK® provides a digital result, indicating the approximate BAC (Blood Alcohol Content) of the test subject. The BACTRACK® is powered by two AA batteries (two AAA batteries for model S30) and is very easy to use. The device employs a silicon sensor of the same type commonly used in handheld breathalyzers. The units are factory calibrated but the product should be recalibrated at least every six to twelve months. If the product is used every day, it may need to be recalibrated as frequently as every month.

The provided text describes the BACTRACK® Select Breathalyzer (models S30, S50, S70) and its substantial equivalence to a predicate device (AL-5000 K061922 SENTECH KOREA CORP). The device is intended to measure alcohol in human breath for the diagnosis of alcohol intoxication.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the BACTRACK® Select Breathalyzer appear to be based on demonstrating "substantial equivalence" to the predicate device, AL-5000 K061922. The key performance metric explicitly stated for both devices is accuracy.

The text also mentions that a "clinical trial performed showed that the over the counter purchaser of this device could read and understand the instructions, could properly use the device, and obtain results that were comparable to those provided by a professional unit administered by a trained observer." This implies an acceptance criterion for user comprehension and ease of use, leading to comparable results, though specific quantitative metrics are not provided.

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

The document does not explicitly state the sample size used for the test set in the clinical trial. It vaguely refers to a "clinical trial." The data provenance is also not specified; it's unclear if the data was collected in the US or another country, or if it was retrospective or prospective.

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

The document states that the clinical trial results were "comparable to those provided by a professional unit administered by a trained observer." This indicates that the ground truth was established by a "professional unit" and a "trained observer." However, the number of such observers/experts and their specific qualifications (e.g., years of experience, specific medical/technical background) are not provided.

4. Adjudication Method for the Test Set

The adjudication method for establishing ground truth in the clinical trial is not explicitly stated. It can be inferred that the "trained observer" operating a "professional unit" provided the reference measurements, implying a single expert's measurement as the ground truth without a clear adjudication process among multiple experts.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described. The study compared the device's results to a "professional unit administered by a trained observer," rather than comparing human readers with and without AI assistance. Therefore, no effect size for human readers improving with AI vs. without AI assistance can be determined from the provided text.

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

The device is a breathalyzer, which is an instrument that directly provides a measurement. Its performance is inherently "standalone" in the sense that it provides a reading. The clinical trial focused on user comprehension and the device's ability to provide results comparable to a professional unit. Therefore, the standalone performance was assessed in terms of its accuracy and comparability to a reference standard, as indicated by the "Accuracy" row in the substantial equivalence chart and the clinical trial description.

7. The Type of Ground Truth Used

The ground truth for the clinical trial was established by a "professional unit administered by a trained observer." This implies a reference measurement obtained using a presumably more accurate or validated professional breath alcohol testing device, rather than pathology, expert consensus (among multiple experts), or outcomes data. This is a form of reference standard.

8. The Sample Size for the Training Set

The document does not provide any information about a "training set" or its sample size. This device is a sensor-based instrument, not a machine learning or AI algorithm that typically requires a training set. Its development and validation would primarily involve engineering and calibration, followed by clinical testing, rather than a machine learning training/testing paradigm.

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

Since there is no mention of a "training set" in the context of this device, this information is not applicable and not provided.

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

The BACTRACK™ Breathalyzer is designed to measure deep lung air to test for the presence of alcohol in the blood. The relationship between alcohol in the blood and alcohol in the deep lung breath is well established by Henry's law in ratio of 2100:1 The BACTRACK™ Breathalyzer is has been tested and uses a blow time of 5 seconds to capture an accurate deep lung sample. The BACTRACK™ Breathalyzer sensor uses tin dioxide which has n-type conductivity when exposed to the atmosphere. This exposure causes a decrease in the number of electrons effecting absorbed oxygen molecules and thus increases resistance. If a specific gas (reducing gas) is presented, a reaction occurs with the absorbed oxygen which causes an increase in the electrons in the oxide molecules causing a decrease in resistance. This change in resistance can be measured and used to identify a specific gas (such as alcohol) and can be quantified into a % concentration.

The K071067 submission describes the BACTRACK™ Breathalyzer Digital Alcohol Detector.

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

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

The submission mentions "user testing data" and a "clinical trial" but does not specify the sample size for these tests.

The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin mentioned. However, the nature of a "clinical trial" and "user testing" generally implies a prospective data collection, likely in the country where the manufacturer operates or seeks approval.

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

The submission states that the clinical trial aimed to: "perform comparably to an evidentiary type of breath alcohol tester." and "obtain results that were comparable to those provided by a professional unit administered by a trained observer."

This implies that the ground truth for the clinical trial was established by an "evidentiary type of breath alcohol tester" operated by a "trained observer." The number of such "observers" or "professional units" is not specified. The qualifications of these observers are limited to "trained," without further detail (e.g., years of experience, specific certifications).

4. Adjudication Method for the Test Set

The submission does not explicitly describe an adjudication method for the test set. The comparison appears to be directly against the "evidentiary type of breath alcohol tester" or "professional unit."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described focuses on comparing the BACTRACK™ Breathalyzer's performance against a "professional unit" and user's ability to operate the device, not on assessing multiple human readers or the effect of AI assistance.

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

Yes, a standalone performance evaluation was done in the sense that the device's accuracy was assessed independently against a reference standard. The "bench tests" and the comparison of the BACTRACK™ Breathalyzer's readings to an "evidentiary type of breath alcohol tester" represent a standalone evaluation of the device's core functionality.

7. The Type of Ground Truth Used

The ground truth used for performance validation was the measurement from an "evidentiary type of breath alcohol tester" or "professional unit." This implies a reference standard that is generally accepted as accurate for breath alcohol measurement.

8. The Sample Size for the Training Set

The submission does not mention a training set or its sample size. The BACTRACK™ Breathalyzer uses a semiconductor-oxide sensor, which suggests a physical-chemical principle of operation rather than a machine learning algorithm that typically requires a training set.

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

Since there is no mention of a training set for machine learning, there is no information provided on how ground truth for a training set was established.

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Intended to measure alcohol in the human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.

The AlcoMate is designed to measure deep lung air to test for the presence of alcohol in the blood. The relationship between alcohol in the blood and alcohol in the deep lung breath is well established by Henry's law in ratio of 2100:1 The AlcoMate is a D.O.T. approved alcohol screening device and uses a blow time of 5 seconds to capture an accurate deep lung sample. The AlcoMate contains a semiconductor oxide sensor designed to test for the presence of alcohol. The AlcoMate semiconductor contains a recently developed ceramic catalytic filter which greatly increases the sensors specificity to alcohol . The AlcoMate sensor uses oxide which has n-type conductivity when exposed to the atmosphere. This exposure causes a decrease in the number of electrons effecting absorbed oxygen molecules and thus increases resistance. If a specific gas (reducing gas) is presented, a reaction occurs with the absorbed oxygen which causes an increase in the electrons in the oxide molecules causing a decrease in resistance. This change in resistance can be measured and used to identify a specific gas (such as alcohol) and can be quantified into a % concentration.

Here's an analysis of the provided text regarding the AlcoMate CA2000 Digital Alcohol Detector's acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document primarily shows the AlcoMate CA2000's performance as "SAME" as the predicate device, implying it meets the predicate's established performance criteria.

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

The provided 510(k) summary does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "bench, DOT, and user testing" and "bench tests, a risk analysis, electrical safety, EMC, DOT testing and user testing data," but without specific numbers or details on the test subjects/data sets.

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

This information is not provided in the given document. The summary focuses on comparing the new device to a predicate device and does not detail the process of establishing ground truth for any testing involving experts. It does mention "DOT testing," which implies adherence to specific standards that would involve calibrated equipment for ground truth, but not human experts in the context of diagnostic interpretation.

4. Adjudication Method for the Test Set

This information is not provided in the given document. Given the nature of a breath alcohol test, adjudication methods involving multiple human readers are not typically applicable. The ground truth would likely be established through calibrated reference instruments.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The device is a standalone diagnostic tool, not an AI assistance tool for human readers.

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

Yes, a standalone performance evaluation was done. The entire premise of a breathalyzer is its standalone capability to measure alcohol in the breath. The document states:

• "The results of bench, DOT, and user testing indicates that the new device is as safe and effective as the predicate device."
• "After analyzing bench tests, a risk analysis, electrical safety, EMC, DOT testing and user testing data, it is the conclusion of Breathalyzer.net that the AlcoMate CA2000 is as safe and effective as the predicate device..."

These statements indicate that the device itself was tested for its accuracy and effectiveness.

7. The Type of Ground Truth Used

The ground truth for the AlcoMate CA2000's performance would have been established using calibrated reference standards and methods. The document mentions:

• "The relationship between alcohol in the blood and alcohol in the deep lung breath is well established by Henry's law in ratio of 2100:1"
• Its accuracy is stated as "±0.01 % at 0.10% BAC," implying comparison to a known, precise Blood Alcohol Concentration.
• "Calibration: BAC simulator" and "Calibration Interval: 1 year" further confirm the use of a calibrated simulator as the ground truth reference.
• "DOT Approval" generally requires adherence to specific protocols, which involve comparison to known alcohol concentrations in controlled environments.

8. The Sample Size for the Training Set

The document does not mention a training set sample size. This device is a sensor-based system that quantifies a physical property (alcohol concentration) based on established chemical principles and sensor response, rather than a machine learning or AI model that requires a distinct training set in the typical sense. Its "training" would be inherent in the sensor's design and calibration.

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

Given that this is not an AI/ML device in the modern sense requiring a "training set," this question is not directly applicable. However, if we interpret "training" more broadly as the process of developing and manufacturing the sensor, the ground truth for establishing the sensor's accurate response to alcohol would be based on controlled environments with known concentrations of alcohol and calibrated reference instruments. The mention of "BAC simulator" for calibration points to this method.

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