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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 AlcoHAWK® PT500 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 AlcoHAWK® PT500 has been tested and uses a blow time of 5 seconds to capture an accurate deep lung sample. The AlcoHAWK® PT500 sensor uses a fuel cell type of detector similar to one found on professional units. It is handheld and uses two AA alkaline batteries as a power source. The mouthpiece is replaceable Plexiglas plastic.

Here's a breakdown of the acceptance criteria and study information for the AlcoHAWK® PT500 Digital Alcohol Detector, based on the provided text:

Acceptance Criteria and Device Performance

Study Information

The provided document describes a "clinical trial" but does not detail it with the same rigor one might expect for a modern AI/device study. The focus is primarily on demonstrating substantial equivalence to a predicate device and user comprehension/usability.

1. Sample sized used for the test set and the data provenance:

   • Sample Size: Not explicitly stated for the "clinical trial." The document mentions "user testing data" and "a clinical trial was performed," but does not provide a number of participants or samples.
   • Data Provenance: Not explicitly stated. Given the context of a 510(k) summary for a US market device, it is implied to be relevant to a US population, but no specific country of origin is mentioned. It's described as a "clinical trial," suggesting prospective data collection, but details are absent.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Number of Experts: Not explicitly stated. The study aimed to show "results that were comparable to those provided by a professional unit administered by a trained observer." This implies one or more "trained observers" were involved, but their qualifications are not detailed beyond "trained observer."
   • Qualifications of Experts: Only "trained observer" is mentioned for the professional unit's administration. No specific years of experience or professional titles (e.g., toxicologist, law enforcement officer) are given.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not explicitly stated. The comparison was against a "professional unit administered by a trained observer," implying a direct comparison rather than a multi-reader adjudication process for ground truth.

4. 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is a standalone breath alcohol detector, not an AI-assisted diagnostic tool that would typically involve human "readers" or "interpreters" whose performance is analyzed.

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

   • Yes, the "clinical trial" assessed the standalone performance of the AlcoHAWK® PT500 in the hands of an "over the counter purchaser" (human-in-the-loop, but measuring the device's output) and compared it to a "professional unit administered by a trained observer." The primary goal was to show the device itself provides comparable results and that users can operate it correctly. The device's measurement function is algorithmic/automated once the breath sample is provided.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The ground truth was established by a "professional unit administered by a trained observer." This implies that the readings from a "professional unit" (likely an evidentiary-type breath alcohol tester) served as the reference standard against which the AlcoHAWK® PT500's readings were compared.

7. The sample size for the training set:

   • Not applicable/Not mentioned. This device is a measurement device, not an AI or machine learning algorithm that typically requires a distinct training set. Its function is based on a fuel cell sensor and established physiological principles (Henry's law), not trained data.

8. How the ground truth for the training set was established:

   • Not applicable. As noted above, there is no mention of a training set for an AI/ML algorithm.

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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 Alcohawk Precision™ 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 Alcohawk Precision™ 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 Alcohawk Precision™ contains a semiconductor oxide sensor designed to test for the presence of alcohol. Gas sensitive semiconductor material is formed on an alumina substrate on which the gold electrodes are printed. A thick film heater of ruthenium oxide is printed on the reverse of the substrate and placed in the plastic housing. The tin dioxide (SnO2) metal 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.

Here's a breakdown of the Alcohawk Precision™ device's acceptance criteria and the study information based on the provided text:

Acceptance Criteria and Device Performance

Note: The 'N/A' for some features indicates that while there are differences, they are either improvements (e.g., 4-digit LED display) or physical attributes that do not directly relate to the device's functional performance or safety compared to the predicate, and thus do not constitute a failure to meet acceptance criteria in the context of substantial equivalence. The key functional criteria like indication for use, accuracy, measurement range, and sensor type are either identical or meet/exceed the predicate.

Study Details

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated. The document mentions "user testing data" and "bench tests", "DOT testing", but the specific number of participants or tests for the "clinical trial" is not provided.
   • Data Provenance: The document does not specify the country of origin for the data. The "user testing data" combined with a "clinical trial" suggests prospective data collection.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Number of Experts: Not explicitly stated.
   • Qualifications of Experts: The document mentions that the clinical trial results were "comparable to those provided by a professional unit administered by a trained observer." This implies the ground truth was established by "trained observers" using "professional units," but their specific qualifications (e.g., medical professionals, certified breath alcohol technicians) are not detailed.

3. Adjudication method for the test set:

   • The document does not describe a formal adjudication method (e.g., 2+1, 3+1). It states that the device could "obtain results that were comparable to those provided by a professional unit administered by a trained observer," suggesting a comparison against a reference standard.

4. 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. This device is a standalone breath alcohol detector, not an AI-assisted diagnostic tool that involves human readers or interpretation of complex data by radiologists/experts. Therefore, an MRMC study is not applicable.

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

   • Yes, the device is inherently a standalone device. The "clinical trial" was performed to establish that users could properly use the device and the device would obtain "comparable results" to a professional unit. This implies evaluating the device's performance directly, independent of human interpretive assistance (beyond basic user operation). The accuracy specified (+/- 0.009%) is for the device itself.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The ground truth was established by measurements from "a professional unit administered by a trained observer." This suggests a reference measurement from a validated, higher-standard breath alcohol testing system. It is a form of reference standard comparison rather than expert consensus on images or pathology.

7. The sample size for the training set:

   • Not applicable. This device is a hardware-based sensor system with a semiconductor oxide sensor, not an AI/machine learning algorithm that requires a "training set" in the computational sense. The device's operation is based on established physical and chemical principles, not learned patterns from data.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no "training set" for this type of device.

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