Search Results

Intended Use
The Soberlink Cellular Device is intended to quantitatively measure alcohol in human breath.

Indications for Use
Measurements obtained by this device are used in the diagnosis of alcohol intoxication.

For Prescription use and OTC use.

The Soberlink Cellular Device is a handheld breath alcohol measurement device with integrated GPS, digital imager, and cellular modem. It is designed to take a deep lung sample of the User's breath, calculate their Blood Alcohol Level (BAC), and send the BAC reading, physical location, and digital image of the User to the Sober Sky Web Portal and Device screen for review.

Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided text:

Device: Soberlink Cellular Device

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 43 participants
• Data Provenance: The document does not explicitly state the country of origin. The study was conducted by the sponsor (Soberlink Healthcare LLC, Huntington Beach, CA, USA), implying the study likely took place in the USA. The study appears to be prospective as it involved asking participants to consume alcohol and then use the device.

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

• The ground truth for the accuracy study was established using an "evidential breath alcohol tester (the BACtrack S80 Pro)." This is a reference device, not human experts.
• For the usability study, the ground truth was assessed by observing if "untrained study participants" could correctly use and interpret the device based on the supplied instructions. No specific number or qualifications of "experts" are mentioned for establishing ground truth in the usability study itself beyond the observed user behavior.

4. Adjudication Method for the Test Set

• For the accuracy study, the adjudication was by direct comparison to the reading of the BACtrack S80 Pro. No human adjudication method (like 2+1 or 3+1 by experts) was mentioned or implied for either the accuracy or usability 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 or human-in-the-loop study was conducted or described in the provided text. This device is a standalone breath alcohol analyzer, not an AI-assisted diagnostic tool for human interpretation.

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

• Yes, the primary performance study (accuracy against the BACtrack S80 Pro) was implicitly a standalone performance assessment of the Soberlink Cellular Device. The device measures BAC and sends the reading, location, and image to a web portal for review, but the core measurement itself is standalone.

7. The Type of Ground Truth Used

• For the accuracy study, the ground truth was established by comparing the device's readings to those of a reference device/evidential breath alcohol tester (BACtrack S80 Pro).
• For precision/reproducibility and interference testing, the ground truth was established by conformance to DOT Testing standards (NHTSA Docket No. 2008-0030).

8. The Sample Size for the Training Set

• The document does not provide information about a "training set" as this device is a physical measurement device, not a machine learning/AI algorithm that typically undergoes a distinct training phase with a specific dataset.

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

• Not applicable, as no training set for a machine learning model is mentioned. The device's calibration and design are based on established scientific principles of electrochemical fuel cell sensors for alcohol detection, calibrated against known standards.

Ask a specific question about this device

The PAS Alcovisor® Satellite™ Breath Alcohol Analyzer is intended to measure alcohol in human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.

The PAS Alcovisor® Mars™ Breath Alcohol Analyzer is intended to measure alcohol in human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.

The PAS Alcovisor® Satellite™ Breath Alcohol Analyzer and the PAS Alcovisor® Mars™ Breath Alcohol Analyzer are breath alcohol test systems designed to sample a user's deep lung breath in order to test for the presence of alcohol. The sensor is an electrochemical fuel cell which will only respond to alcohol. After the user blows into the device using a disposable mouthpiece, for 3-4 seconds, a small sample of breath is drawn into the fuel cell by an automatic pump and a chemical reaction between the alcohol and fuel cell occurs. This reaction generates an electrical current which is directly related to the amount of alcohol in the sample. The current is then converted to a Blood Alcohol Concentration (BAC) level and displayed for the user. The relationship between alcohol in a person's deep lung breath and in their blood is well established using Henry's law, which gives a ratio of 2100:1.

The Satellite™ and Mars™ are handheld devices made from durable plastic with an internal circuit board. The Satellite™ uses an internal rechargeable battery and the Mars™ uses three AAA batteries.

The provided text describes the PAS Alcovisor® Satellite™ and Mars™ Breath Alcohol Analyzers. Here's a breakdown of the acceptance criteria and the study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states the "Accuracy" and "NHTSA (DOT)-Approval" as comparable features between the predicate and the new devices. While other features like sensor type, mouthpiece, power source, dimensions, construction, weight, warm-up time, measurement site, battery life, and intended user are listed for comparison, they are described as direct equivalences or minor technological differences, rather than distinct "acceptance criteria" with specific thresholds reported for the new device. The "Accuracy" is the most direct performance metric given an acceptance range and the device's reported performance within that range.

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

• Sample Size: Not explicitly stated. The document mentions "consumer field evaluations" for verification and "tests conducted by the US Department of Transportation (National Highway Traffic Safety Administration (NHTSA)) for approval as an Alcohol Screening Device." However, the exact number of participants or tests for these evaluations is not provided.
• Data Provenance: The tests were conducted by the US Department of Transportation (National Highway Traffic Safety Administration (NHTSA)). The nature of the "consumer field evaluations" is not further detailed, so specific countries of origin beyond the US (for NHTSA) are unknown. The evaluations appear to be prospective as they were conducted to obtain approval for the devices.

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

• Number of Experts: Not specified.
• Qualifications of Experts: The ground truth was established by the US Department of Transportation (NHTSA). While the document doesn't detail the qualifications of specific individuals, NHTSA's role implies that the tests and their interpretation were conducted by qualified personnel experienced in alcohol breath testing device evaluation and regulatory standards.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly described. The testing for NHTSA approval implies a standardized method for determining alcohol content, likely using a known standard or reference method (e.g., blood alcohol tests or calibrated alcohol solutions) that serves as the ground truth. There is no mention of a human expert consensus or multiple reader adjudication process for the test set results.

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, an MRMC comparative effectiveness study was not done. This device is a standalone breath alcohol analyzer, not an AI-assisted diagnostic tool that requires human interpretation. Therefore, the concept of human readers improving with or without AI assistance is not applicable.

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

• Yes, a standalone performance study was done. The device's performance was evaluated by the NHTSA for approval as an Alcohol Screening Device. This implies testing of the device itself (algorithm + hardware) to accurately measure alcohol content in human breath, without a human-in-the-loop interpretation process beyond operating the device.

7. The Type of Ground Truth Used

• Ground Truth Type: The ground truth for evaluating the device's accuracy would have been based on known alcohol concentrations. This could involve:
  • Calibrated alcohol standards: Using solutions or simulators with precisely known alcohol concentrations.
  • Reference methods: Comparing breath readings to a validated, accurate blood alcohol concentration (BAC) measurement, which is considered the gold standard for alcohol intoxication.
  • The document implies the tests were conducted for "approval as an Alcohol Screening Device" by NHTSA, which follows strict protocols for establishing accurate alcohol levels.

8. The Sample Size for the Training Set

• Not applicable. This device is a physical instrument with an electrochemical fuel cell sensor and embedded logic, not a machine learning or AI model that requires a "training set" in the conventional sense of AI development.

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

• Not applicable. As the device does not rely on a machine learning "training set," there is no ground truth established for such a set. The device's underlying principles are based on the chemistry of its sensor and established physiological relationships (Henry's law) rather than data-driven learning.

Ask a specific question about this device

The PAD Breath Alcohol Tester is a screening device for the rapid detection of alcohol in the human breath. Measurements obtained by this device are used in the diagnosis of alcoholic intoxication.

The PAD is a self-contained unit with 3 digit LCD display, and power button. The 3 digit LCD display window displays the alcohol concentration in increment of 0.01%. The display is also capable of displaying L-b, S-E, t-F, L-t, n-C, HI and these states low battery, sensor error, test fail, low temperature, need calibration , high concentration, respectively. The unit is powered by two AAA batteries.

Acceptance Criteria and Device Performance Study for PAD (Personal Alcohol Detector)

This document outlines the acceptance criteria and the study conducted to demonstrate that the PAD (Personal Alcohol Detector) device meets these criteria.

1. Acceptance Criteria and Reported Device Performance

Note: The provided document states "Accuracy at a Blood Alcohol Concentration greater than 0.032% has not been established," which is an important limitation to note regarding the scope of established accuracy.

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

The document states that a "clinical trial was performed to establish that the user could read and understand the instructions provided, and properly use the device. as well as perform comparably to an evidentiary type of breath alcohol tester."

• Sample Size: The exact sample size for the "user testing" and "clinical trial" is not specified in the provided text.
• Data Provenance: The country of origin of the data is not explicitly stated. Given that the submitter is "SEJU Engineering Co., Ltd." from "Republic of Korea" and the 510(k) summary is addressed to the "Food and Drug Administration," it is plausible the study was conducted to meet FDA requirements, potentially involving data from various sources. The study is described as a "clinical trial," implying it was prospective in nature for this device.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• The document mentions that the clinical trial aimed to "perform comparably to an evidentiary type of breath alcohol tester." This implies that the ground truth for alcohol concentration was established using an "evidentiary type of breath alcohol tester," which is typically a highly accurate and calibrated device used by trained professionals (e.g., law enforcement or medical personnel).
• The number of experts or specific qualifications of those operating the evidentiary breath alcohol tester is not specified in the provided text. However, "evidentiary type" implies professional operation and established protocols for accuracy and calibration.

4. Adjudication Method

The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for the test set. The comparison was made against "an evidentiary type of breath alcohol tester," suggesting a direct comparison of results rather than a consensus-based adjudication process for human interpretation of results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study was not explicitly performed or described in the provided text. The study focused on demonstrating that "the user could read and understand the instructions provided, and properly use the device, as well as perform comparably to an evidentiary type of breath alcohol tester." This implies assessing user interface and device performance against a gold standard, not a comparison of human reader performance with and without AI assistance. The device itself is a standalone measurement tool, not an AI-assisted diagnostic aid for human interpretation.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study was implicitly done as the core of the clinical trial was to assess the device's ability to "perform comparably to an evidentiary type of breath alcohol tester." The device produces a direct numerical output (BAC) based on its sensor and algorithm, without human interpretation as part of the primary result. The section on "Measurement Accuracy" with a tolerance of "±0.01 at 0.10%BAC" is a measure of standalone performance.

7. Type of Ground Truth Used

The ground truth used was based on measurements from an "evidentiary type of breath alcohol tester." This type of device is considered a gold standard for measuring Blood Alcohol Concentration (BAC) from breath samples, providing objective, quantitative data.

8. Sample Size for the Training Set

The document does not specify a separate training set or its sample size. For a traditional breath-alcohol tester, "training" often refers to the calibration and internal development/testing of the sensor and algorithms by the manufacturer, rather than a distinct "training set" of patient data in the way an AI/ML model would use it.

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

As no separate training set is explicitly mentioned, the method for establishing ground truth for a training set is not described. The device's performance relies on its sensor technology and internal calibration, which would typically be validated against known alcohol concentrations or reference devices during the manufacturing and quality control process.

Ask a specific question about this device

The Alco-Breath Tube is a device to test for alcohol in human breath. It is a disposable device designed for one-time use and is a screening test that gives preliminary results. This device provides a semi-quantitative estimate of alcohol levels in breath. The ABT-08 device gives readings between 0 and 0.08% BAC and the ABT-15 device gives readings between 0 and 0.15% BAC.

The CheckPoint breath alcohol test is a device to test for alcohol in human breath. It is a disposable device designed for one-time use and is a screening test that gives preliminary results. The test is available at cut-offs of 0.02, 0.04, 0.05, and 0.08% BAC.

The Alco-Breath Tube is a disposable, one-time use in vitro diagnostic (IVD) device using a length-of-stain method to give estimates of alcohol concentrations. A chemical reaction occurs when the reagent-treated silica gel is exposed to breath alcohol at or greater than the threshold level of the test device. The results are interpreted based on the observation of a color change within a specified period of test time. The color change is proportional to the concentration of alcohol in the breath. The device provides preliminary screening test results and is not intended to be used as evidential results.

The Alco-Breath Tube is intended to detect the presence of alcohol in the breath at concentrations between 0.02 BrAC (Breath Alcohol Concentration) and 0.08 or 0.15 BrAC. The Alco-Breath Tube is intended for screening in medical and therapeutic programs. This product will also give a semi-quantitative estimate of alcohol levels in these ranges. The Alco-Breath Tube is a disposable device designed for one-time use.

The CheckPoint® Breath Alcohol Test is a disposable, one-time use in vitro diagnostic (IVD) device using a color change to indicate the presence of alcohol. A chemical reaction occurs when the reagent-treated silica gel is exposed to breath alcohol at or greater than the threshold level of the test device. The results are interpreted based on the observation of a color change within a specified period of test time. The device provides preliminary screening test results and is not intended to be used as evidential results.

The CheckPoint® Breath Alcohol Test is intended to detect the presence of alcohol in the breath at a concentration of 0.02% or greater. The CheckPoint® comes in four different alcohol levels: 0.02%. 0.04%. 0.05%. and 0.08%. The alcohol level for each device is printed on the label of the device. The CheckPoint® Breath Alcohol Test are a disposable device designed for one-time use and is intended for screening in medical and therapeutic programs.

The Alco-Breath Tube and CheckPoint® Breath Alcohol Test are intended to detect the presence of alcohol in breath. The summary provides details on the performance evaluation studies conducted and the standards followed.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document references "Performance Specifications" and lists several analytical performance tests, but it does not explicitly state quantitative acceptance criteria or corresponding reported device performance values in a table format. It only lists the types of tests conducted:

The document states: "The conduct of performance evaluation studies is based on the most current National Highway Traffic Safety Administration (NHTSA)/ DOT guidance document. 'Highway Safety Programs; Model Specifications for Screening; Devices to Measure Alcohol in Bodily Fluids'." This implies that the acceptance criteria are derived from this guidance, but the concrete thresholds are not explicitly stated in this document.

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "performance evaluation studies" and "usability tests" but does not quantify the number of samples or participants.
• Data Provenance: Not explicitly stated. The document refers to NHTSA/DOT guidance, which is a national standard for alcohol screening devices in the US, suggesting the data would likely be from studies conducted within the US, but this is not definite. It also doesn't specify if the studies were retrospective or prospective.

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

Not explicitly stated. The document does not mention the use of experts for establishing ground truth, nor their number or qualifications. The comparative effectiveness study is referenced in the context of the device's performance against established standards, not against expert consensus.

4. Adjudication Method for the Test Set:

Not applicable/Not explicitly stated. The document does not describe an adjudication method. The device provides "preliminary screening test results" based on a visual color change in a chemical reaction. The interpretation is based on observation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Was it done? No. The document does not describe a MRMC comparative effectiveness study where human readers improve with AI vs. without AI assistance. The device itself is a standalone, single-user chemical test with visual interpretation, not an AI-assisted diagnostic tool for human readers.
• Effect size of human readers improving with AI vs. without AI assistance: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Yes, in essence. The Alco-Breath Tube and CheckPoint® Breath Alcohol Test are described as "disposable, one-time use in vitro diagnostic (IVD) device[s] using a length-of-stain method to give estimates of alcohol concentrations" or "using a color change to indicate the presence of alcohol." The "device provides preliminary screening test results and is not intended to be used as evidential results." The mechanism is a chemical reaction with visual interpretation by the user, making it a standalone test where the device's chemical reaction (analogous to an algorithm in this context) directly produces the result for human interpretation. The "usability tests were conducted to determine if consumers can correctly perform and interpret tests according to the package insert," which suggests a human-in-the-loop component for interpretation, but the core "algorithm" (chemical reaction) is standalone.

7. Type of Ground Truth Used:

The ground truth for the performance evaluation studies (Precision/Reproducibility, Detection Limit, Analytical Specificity, Comparison Studies) is implicitly based on reference alcohol concentrations used in laboratory settings, as dictated by the NHTSA/DOT guidance mentioned. The comparison studies would involve comparing the device's results against established methods of measuring alcohol concentration to verify accuracy.

8. Sample Size for the Training Set:

Not applicable. This device is a chemical screening test, not a machine learning or AI algorithm that requires a training set in the conventional sense.

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

Not applicable. As this is not a machine learning model, there is no training set or associated ground truth establishment process for a training set.

Ask a specific question about this device

The BreathScan PRO is an in vitro medical device that quantitatively detects the presence of alcohol in the human breath. The system is used only as a screening device and is an indication of the presence of alcohol in the blood of the test subject.

The BreathScan PRO is quantitative screening test for alcohol in the human breath and provides a digital readout. The BreathScan PRO consists of a selfcontained electronic analyzer to quantitatively detect the presence of alcohol in the human breath. The detection level range is from 0.00% to 0.15%. Breath Alcohol concentrations higher than 0.15% will be displayed as BAC >0.15%. The electronic Analyzer is factory pre-calibrated and is ready to use when a Detector is fully inserted into the sample port. It is a re-usable device designed for use specifically with BreathScan®PRO detectors.

The detectors are disposable screening devices designed for one time use. The BreathScan®PRO Electronic Analyzer enables the user to read or interpret their BreathScan PRO Detectors charged by human breath. The system provides an indication of the possible presence of alcohol in the blood of the test subject.

The detectors contains chemicals that change color in the presence of alcohol vapors) utilizing the patented technology. The Detector consists of two parts. One part is a glass capsule containing light yellow crystals that change color when exposed to alcohol vapors. The other part is a plugged, plastic tube with an opening to blow into while running the test.

When the subject exhales into the tube, the fresh crystals interact with breath vapor and change color from yellow to blue green if alcohol is present. Note: The resulting color change is dependent upon the level of alcohol detected.

The blow bags are re-usable and serve as a method to assure that the subject has blown through the Detector with adequate air. With the BreathScan PRO. this is required (DOT/NHTSA compliance). ABI provides these in the starter kit and as an option for future orders.

Here's an analysis of the provided information regarding the BreathScan®PRO device, focusing on acceptance criteria and the supporting study:

1. Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific quantitative acceptance criteria for parameters like accuracy, precision, or false positive/negative rates prior to presenting the study results. Instead, it implies a comparison to a predicate device (Breath Alcohol .02 Detection System K062971) and an evidentiary breath test (ALCO SENSOR IV).

However, the study results themselves can be interpreted as demonstrating the device's performance against an implicit standard set by the comparator device. The document also mentions meeting DOT/NHTSA guidelines as an acceptance benchmark.

Implicit Acceptance Criteria and Reported Device Performance:

Study that Proves the Device Meets the (Implicit) Acceptance Criteria:

The key study presented is a comparison of the BreathScan®PRO against the ALCO SENSOR IV, which is described as an "Evidentiary Breath Test" and a "DOT/NHTSA approved device."

The study is described as:

• Bench test and user testing data for safety and effectiveness.
• A comparison to the Evidentiary Breath Test (Alco-Sensor IV), the results of which are depicted in the scatter plot.
• User studies to assess user comprehension and proper usage, obtaining comparable results to a predicate device.

2. Sample Size and Data Provenance

• Test Set Sample Size: 62 total subjects were used for the comparison study with the Alco-Sensor IV.
• Data Provenance: Not explicitly stated (e.g., country of origin). The study appears to be prospective as it involves user testing and data collection for comparison.

3. Number of Experts and Qualifications for Ground Truth

• The document mentions comparison to the ALCO SENSOR IV, which is an "Evidentiary Breath Test" and a "DOT/NHTSA approved device." The results from this device are essentially considered the ground truth for the quantitative comparison.
• It also states that user studies obtained results "comparable to those provided by a predicate device administered by a trained technician." While not directly defining the ground truth for measurement, this implies the benchmark performance of the predicate device under expert operation.
• The number of "experts" (or trained technicians operating the Alco-Sensor IV) is not specified. Their specific qualifications (e.g., years of experience) are also not specified beyond "trained technician."

4. Adjudication Method

• The document does not describe an adjudication method (e.g., 2+1, 3+1) for establishing ground truth. The Alco-Sensor IV appears to be the single source of ground truth for BAC measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not explicitly mentioned or performed in the provided text. The study focuses on comparing the device's readings to an evidentiary breath test and assessing user performance, not on how human readers' diagnostic accuracy improves with or without AI assistance. The BreathScan®PRO is a standalone device with a digital readout, not an AI-assisted diagnostic tool for human interpretation.

6. Standalone Performance Study

• Yes, a standalone performance study was done. The core "bench test" and "user testing data" with the comparison to the Alco-Sensor IV evaluates the algorithm's (device's) performance in generating the quantitative digital readout of BAC. The digital readout is inherently the algorithm's output.

7. Type of Ground Truth Used

• The primary ground truth used for quantitative comparison was the readout from a legally recognized evidentiary breath test device (ALCO SENSOR IV). This is a form of device-based ground truth using a gold-standard instrument.
• For the user studies, the ground truth was implied to be the results obtained by a trained technician operating a predicate device, which served as the benchmark for comparison of user-obtained results.

8. Sample Size for the Training Set

• The document does not specify the sample size for a training set. This is a device for detecting alcohol in breath, not typically an AI/ML model that undergoes a distinct training phase in the same way. The device is factory pre-calibrated.

9. How Ground Truth for the Training Set Was Established

• As a factory pre-calibrated device rather than a machine learning model, the concept of a "training set" and establishing ground truth for it in the typical AI context does not apply directly. The document states the electronic Analyzer is "factory pre-calibrated." The methods for this pre-calibration and the ground truth used during that calibration are not detailed in the provided text.

Ask a specific question about this device

The Contralco Alcohol Breath Tester is an in vitro medical device to semi-quantitatively detect the presence of alcohol in the human breath. It is a disposable screening device for one-time use. The detector is available at several detection cut-offs: 0.02, 0.04, 0.05, 0.06, 0.08, and 0.10 relative percent Blood Alcohol Concentration (BAC). The device is used only as a screening device and is only an indication of the possible presence of alcohol in the blood of the test subject.

The Contralco Alcohol Breath Tester is a visual qualitative test for alcohol in human breath. The Tester contains chemicals that change color in the presence of alcohol vapors. The Tester is made up of 2 parts: the reagent and the plastic bag. One part contains light yellow crystals that change color when exposed to alcohol vapors. The other part (plastic bag) collects the volume of air necessary for the analysis. If alcohol is present, the crystals will change from yellow to light green. The number of crystals that change color will depend on the cut-off of the Tester and the amount of alcohol in the breath. The yellow crystals in the reagent are coated with Chromium VI oxide (CrO3) and sulfuric acid (H2SO4). The amount of these indicator chemicals is adjusted according to the selected cut-off of the tester. A color change is produced when alcohol vapors are oxidized to acetic acid and the indicator chemicals change to chromium sulfate [Cr2(SO4)3]. The majority of crystals change from yellow to light green when alcohol vapors are present at a level equal to or exceeding the cut-off of the Tester. The Contralco Tester is available in several cut-offs (0.02, 0.04, 0.05, 0.06, 0.08 and 0.10%). The cut-off is printed on the Tester label and is expressed as a specific percentage of breath alcohol.

The Contralco Alcohol Breath Tester is an in vitro medical device designed to semi-quantitatively detect alcohol in human breath. The device is a disposable screening tool for one-time use, available in several cut-offs: 0.02, 0.04, 0.05, 0.06, 0.08, and 0.10 relative percent Blood Alcohol Concentration (BAC). It is intended for over-the-counter use as a screening device to indicate the possible presence of alcohol in the blood.

A study was conducted to assess the safety and effectiveness of the Contralco Alcohol Breath Tester by comparing its performance against a quantitative comparator device (LION, manufactured by LION LABORATORIES LIMITED) and to confirm that consumers could correctly perform and interpret the test according to the package insert.

1. Acceptance Criteria and Reported Device Performance:

The document implicitly defines the acceptance criteria as the device results being "coherent" with the quantitative comparator device, with a specified effectiveness percentage. No explicit qualitative criteria for "coherent" are provided beyond the single reported disagreement.

2. Sample Size and Data Provenance:

• Test Set Sample Size: 59 measures/volunteers.
• Data Provenance: The study was conducted at the exit of a nightclub. The country of origin is not explicitly stated, but the submitter is from France. The study appears to be prospective, involving volunteers in a real-world setting.

3. Number of Experts and Qualifications for Ground Truth:

• Number of Experts: One trained individual operated the quantitative comparator device (LION).
• Qualifications of Experts: The individual operating the quantitative device is described as "trained." Further specific qualifications (e.g., years of experience, certification) are not provided.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. The study design involved a direct comparison between the subject device (interpreted by volunteers) and a quantitative comparator device (operated by a trained individual) as the ground truth. There was no mention of multiple reviewers adjudicating the results of the Contralco device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• MRMC Study: No. This study does not appear to be an MRMC study. It focused on the Contralco device's performance as interpreted by consumers versus a quantitative reference, rather than comparing human reader performance with and without AI assistance.

6. Standalone Performance:

• Standalone Performance: Yes, the study essentially tested the standalone performance of the Contralco Alcohol Breath Tester as interpreted by users. The "volunteers blew in balloons, and interpreted the results of the reactant." This represents the device's performance without a human expert interpreting its immediate output. The comparison data from the LION device served as the reference.

7. Type of Ground Truth Used:

• Ground Truth: Quantitative measurements from a LION Alcohol Breath Tester, operated by a trained individual. This serves as a reference standard for Blood Alcohol Concentration (BAC).

8. Sample Size for the Training Set:

• Training Set Sample Size: Not applicable. This device is a chemical-based test kit and does not involve AI or machine learning models that require a training set. The calibration of the device with different cut-offs (e.g., 0.05% BAC) is an intrinsic property of its chemical composition, adjusted according to the desired detection cut-off.

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

• Ground Truth for Training Set: Not applicable. As noted above, there is no training set for this device. The "training" of the device is its manufacturing process where the amount of indicator chemicals (Chromium VI oxide and sulfuric acid) is adjusted to produce a color change at specific cut-off levels.

Ask a specific question about this device

The Breath Alcohol Detector is for the semi-quantitative rapid detection of the presence of alcohol in the exhaled breath. The Breath Alcohol Detector indicates relative Blood Alcohol Concentration (BAC) at 0.02%, 0.04%, 0.05%, 0.06%, 0.08% or 0.10% cut-off levels. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.

The Breath Alcohol Detector is a visual semi-quantitative test for the detection of alcohol in the exhaled breath. The Breath Alcohol Detector consists of a plastic tube, two plastic plugs, a blow bag (optional), a tube label and a glass vial encased with reaction crystals. The crystals employ a solid-phase chemistry system based on chemically chromogenic reaction. Alcohol, if present in the exhaled breath, reacts with the chemically coated crystals and produces a color change. This color change is proportional to the concentration of alcohol in the breath, which is an approximation of relative Blood Alcohol Concentration (BAC). The Breath Alcohol Detector is available with or without blow bags in six cut-off levels: 0.02%, 0.04%, 0.05%, 0.06%, 0.08% or 0.10% cut-off levels.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria in a table format. However, it implies that the device had to demonstrate properties equivalent to the predicate device and meet certain performance characteristics. It indicates that the device achieved "comparable readings" to a DOT/NHTSA approved evidential breath test device.

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

• Sample Size for Test Set: The document does not specify the exact number of individuals (laypersons and trained laboratory technicians) who participated in the clinical study. It states that "Clinical studies were conducted with laypersons and trained laboratory technicians."
• Data Provenance: The data was gathered from a prospective clinical study specifically conducted for this device. The country of origin for the data is not explicitly stated, but the submitting company (ACON Laboratories, Inc.) is based in San Diego, California, USA, and the predicate device is from New Jersey, USA, suggesting the study was likely conducted in the USA.

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

• Number of Experts: Not explicitly stated. The ground truth was established by "trained laboratory technicians" using an "evidentiary breath test, Alco-Sensor IV."
• Qualifications of Experts: The experts were described as "trained laboratory technicians." Their specific experience (e.g., years of experience) is not provided, but their use of a DOT/NHTSA approved device implies they are qualified operators of such equipment for accurate breath alcohol measurement.

4. Adjudication Method for the Test Set:

• The document does not describe an adjudication method in the typical sense of expert review for discrepancies. Instead, the study directly compared the device's readings obtained by laypersons to the results obtained by trained technicians using a reference device (Alco-Sensor IV). The 'ground truth' was assumed to be the Alco-Sensor IV reading.

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

• No, a formal MRMC comparative effectiveness study was not reported. The study focused on comparing the performance of the device (operated by laypersons) against a reference device (operated by trained technicians), not on comparing multiple human readers with and without AI assistance.

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

• This device is a physical, chromogenic reaction test. It actively involves a human user blowing into it and visually interpreting the results. Therefore, a "standalone algorithm only" performance evaluation is not applicable and was not performed. The performance of the device without a human "in the loop" doesn't make sense for this type of product.

7. The Type of Ground Truth Used:

• The ground truth was established by an evidentiary breath test (Alco-Sensor IV) which is a DOT/NHTSA approved device. This represents a highly reliable, accepted method for measuring breath alcohol concentration, essentially acting as the gold standard for comparison in this context.

8. The Sample Size for the Training Set:

• The document does not provide information regarding a separate "training set" or its sample size. This type of chemical-based, visual read device typically undergoes analytical validation and clinical validation, rather than a machine learning model's training and testing split. The "analytical performance characteristics" and "clinical study" sections describe the validation process.

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

• Given that no machine learning training set is mentioned or implied, this question is not applicable. The "ground truth" for the overall validation was established by the Alco-Sensor IV as described above.

Ask a specific question about this device

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

The AlcoDigital Breathalyzer AT576, AT577, AT578, AT579 are designed to measure deep lung air to determine the level of alcohol in the blood. The relationship between alcohol in the blood and in the deep lung breath is well established by Henry's law in ratio of 2100:1. The alcohol sensor is electrochemical fuel cell type, and the unit has been designed to blow 6 seconds to get the sample of alcohol, the sensor generates an output by electronic voltage, which is proportional to the concentration of alcohol in the blood. The unit is powered by 1 pcs 9V battery or DC12V input.

Here's an analysis of the provided 510(k) summary for the AlcoDigital Breathalyzer, organized according to your request:

Acceptance Criteria and Device Performance Study

The 510(k) summary presents a comparison between the subject device (AlcoDigital Breathalyzer, Model AT576, AT577, AT578, AT579) and a predicate device (AlcoHAWK PT500 Digital Alcohol Detector, K080848) to establish substantial equivalence. The primary acceptance criterion highlighted and the related performance is "Accuracy."

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document implicitly suggests that the predicate device met similar accuracy criteria, and thus established a benchmark for substantial equivalence. However, the specific accuracy of the predicate is not explicitly stated in this segment.

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

The provided 510(k) summary states that "A clinical trial was performed to establish that the user could read and understand the instructions provided, and properly use the device." However, it does not specify the sample size used for this clinical trial (test set) or the data provenance (e.g., country of origin, retrospective or prospective nature).

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

The document does not provide information regarding the number of experts used to establish ground truth or their qualifications. The "clinical trial" mentioned focuses on user understanding and proper device use, not on validating the accuracy against an expert-established ground truth. Breathalyzers typically establish ground truth against laboratory-grade reference instruments or blood alcohol content (BAC) measurements.

4. Adjudication Method for the Test Set

The 510(k) summary does not specify any adjudication method for the test set.

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 done. This type of study is more common for diagnostic imaging AI, where multiple human readers interpret cases with and without AI assistance. This device is a direct measurement tool, not an interpretive aid for human readers.

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

The document mentions "bench and user testing" and "A clinical trial was performed to establish that the user could read and understand the instructions provided, and properly use the device." The "Accuracy" specification (±0.005% at 0.05%) suggests some level of standalone technical performance evaluation was conducted, likely in a laboratory bench setting to assess the sensor's precision against controlled alcohol concentrations. However, a dedicated study explicitly labeled "standalone performance" is not described with methodological detail. The clinical trial focused on user interaction with the device.

7. The Type of Ground Truth Used

The most common ground truth for breathalyzers is Blood Alcohol Content (BAC) measured through a laboratory reference method (e.g., gas chromatography) or a highly accurate, calibrated reference breath alcohol instrument. While the 510(k) summary states the device "generates an output by electronic voltage, which is proportional to the concentration of alcohol in the blood," it does not explicitly state how the ground truth for the accuracy claim (±0.005% at 0.05%) was established for the testing that generated this figure. It's implied a reference standard was used, but not specified.

8. The Sample Size for the Training Set

The 510(k) summary does not mention a training set sample size. Breathalyzers, particularly those based on electrochemical fuel cells, utilize established physical principles and calibrated sensors rather than machine learning algorithms that require large training datasets in the same way an AI diagnostic device would. Therefore, the concept of a "training set" for an algorithm isn't directly applicable in the typical sense for this device.

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

As there's no mention of a "training set" in the context of an algorithm, the document does not describe how ground truth for a training set was established.

Ask a specific question about this device

The LifeGuard and BacTrack B90 devices are intended to measure alcohol in human breath. Measurements obtained from these devices are used in the diagnosis of alcohol intoxication.

The LifeGuard and BacTrack B90 devices are intended to be used by the general adult population and by qualified personnel, such as physicians, nurses, and technicians.

The LifeGuard and BacTrack B90 devices are intended to be used by adults (age 21 and over) in measuring alcohol intoxication in themselves or others.

The LifeGuard and BacTrack B90 devices are intended to be used in both home (over-the-counter) and clinical settings.

The LifeGuard product is a breath alcohol detector designed to sample the patient's deep lung air in order to test for the presence of alcohol in the blood. The sensor used in the LifeGuard is an electrochemical fuel cell sensor. When the patient exhales into the device, after 4 seconds a sample of the breath is pumped into the fuel cell and generates an electrical current. The amount and duration of the current has a known relationship to the concentration of alcohol in the breath sample. The relationship between the alcohol concentration in the deep lung breath and in the blood is known by Henry's law with a ratio of 2100:1.

The BacTrack B90 has the same intended use, description and performance characteristics as the LifeGuard with a different physical appearance.

Both the LifeGuard and BacTrack B90 products are handheld and are used with a single-use disposable mouthpiece and a replaceable 9 volt battery.

Here's an analysis of the provided text regarding the LifeGuard and BacTrack B90 devices, focusing on the acceptance criteria and the study that proves they meet those criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

The primary acceptance criterion mentioned is accuracy. The device's performance is directly compared to its predicates.

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

The document mentions "laboratory bench testing" and "user studies,". However, specific sample sizes for the test set or information on data provenance (e.g., country of origin, retrospective/prospective) are NOT provided in the given text.

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

The document does not provide information on the number or qualifications of experts used to establish ground truth for the test set.

4. Adjudication Method for the Test Set:

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set.

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

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study is mentioned. This device is a breathalyzer, so the concept of "human readers" interpreting images with and without AI assistance is not applicable. The device provides a direct measurement.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

The "laboratory bench testing" described for the device would represent its standalone performance, as it verifies the hardware and firmware performance against specifications. However, the exact details of this testing (e.g., specific algorithms or human intervention) are not extensively detailed, beyond its function as a breath alcohol detector.

7. The Type of Ground Truth Used:

For the accuracy testing, the ground truth would likely be established by a calibrated alcohol standard or controlled human breath samples with known alcohol concentrations. While not explicitly stated, this is the standard method for establishing ground truth in breath alcohol measurement devices. The document implies this through the accuracy claims. The statement "The relationship between the alcohol concentration in the deep lung breath and in the blood is known by Henry's law with a ratio of 2100:1" indicates the scientific basis for the measurement, further implying a quantitative ground truth for alcohol concentration.

8. The Sample Size for the Training Set:

The document does not provide any information regarding a training set or its sample size. This type of device relies on a fixed scientific principle (electrochemical fuel cell and Henry's law) rather than machine learning algorithms that typically require large training datasets.

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

As there's no mention of a training set in the context of machine learning, this question is not applicable. The device's underlying principle is a direct chemical measurement, not a learned model from data. The device's 'training' or calibration would be through manufacturing processes and in-field calibration against known alcohol standards.

Summary of Study Details Provided in the Text:

The text states that the device meets acceptance criteria through:

• Laboratory bench testing: To verify hardware and firmware performance against specifications. This would explicitly test accuracy and other technical parameters.
• NRTL safety testing: To certify compliance with US and European safety standards.
• User studies: To validate that the device met user requirements and that labeling was adequate.

The conclusion asserts that "the LifeGuard design, feature set, verification and validation results, and agency testing reports demonstrate that the LifeGuard breath alcohol tester is a safe, effective product that is substantially equivalent to other FDA cleared alcohol breath testing products." This implies that the tests conducted were sufficient to demonstrate equivalence in terms of safety and effectiveness to the predicate devices, particularly in the realm of accuracy.

Ask a specific question about this device

The Alco Tube Plus Alcohol Detector is an in vitro medical device to qualitatively detect the presence of alcohol in the human breath. It is a disposable screening device for one-time use. The detector is available in two cut-offs including 0.05 and 0.08 percent breath alcohol. The device is used only as a screening device and is only an indication of the possible presence of alcohol in the blood of the test subject.

The Alco Tube Plus Alcohol Detector (Tester) is a visual qualitative test for the presence of alcohol in human breath. The tester is constituted of glass tubing containing a reagent of yellow crystals that change color when exposed to alcohol vapors. The other part is an opening to blow into while running the test. If alcohol is present, the crystals will change from yellow to green. How many crystals turn color will depend on the cut-off of the Tester and how much alcohol is in the breath. The yellow crystals are coated with Potassium dichromate and sulfuric acid. The amount of these indicator chemicals is adjusted according to the selected cutoff of the Tester. A color change is produced when alcohol vapors are oxidized to acetic acid and the indicator chemicals change to chromium sulfate. The majority of crystals change from yellow to green when alcohol vapors are present at a level equal to or exceeding the cutoff of the Tester. The Alco Tube Plus is available in two cut-offs (0.05%) The cut-off is printed in the instructions and is expressed as a specific percentage of breath alcohol

Here's a breakdown of the acceptance criteria and the study details for the Alco Tube Plus Alcohol Detector, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state "acceptance criteria" in terms of specific performance metrics that the device must meet (e.g., minimum sensitivity, specificity, or accuracy thresholds). Instead, the study's aim was a "Comparison to Evidentiary Breath Test (Alco-Sensor IV)" and to demonstrate that the device is "as safe and effective as the predicate device." The tables provided show the device's performance against different quantitative breath alcohol levels.

Therefore, the "acceptance criteria" can be inferred as the device demonstrating reliable qualitative detection of alcohol at its specified cut-offs (0.05% and 0.08%) when compared to an evidentiary breath test, with no false positives below these cut-offs and clear positive indications at or above them.

• Near cutoff positive (> 0.05 - 0.083%): 70
• Greater than cutoff + 60% (> 0.083%): 21
  Negative Results:
• Less than cutoff - 60% (0.05 – 0.083%): 70
• Greater than cutoff + 60% (> 0.083%): 21
  Negative Results:
• Less than cutoff – 60% (

Ask a specific question about this device