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The iCOquit® Smokelyzer® breath carbon monoxide (CO) monitor is intended for single patient use by cigarette smoking individuals, notifying the individual user of the amount of CO on their breath produced as a consequence of smoking activity. The device can be used in smoking cessation programmes.

The iCOquit® Smokerlyzer® device is a hand-held breath monitor for the detection of Carbon Monoxide (CO) on the breath, using a non-invasive method of breath analysis to detect levels of Carbon Monoxide (CO). The iCOquit® Smokerlyzer® device works in conjunction with the iCOquit® App developed for smartphone or tablet, which the user pairs to the device via Bluetooth. The iCOquit® App works in conjunction with the iCOquit® Smokerlyzer® personal stop-smoking tool to provide visual motivation to help the user quit as track their quitting progress in real-time. The iCOquit® Smokerlyzer® is an over-the-counter, hand-held breath monitor. It is not for use with other inhaled products. Using an electrochemical sensor designed to react specifically to carbon monoxide producing an electrical output, the sensor measures the level of carbon monoxide (CO) on the breath. The output is then amplified into a meaningful result by the device. The result is sent to the iCOquit® App wirelessly, allowing the meaningful result to be displayed on the user's smartphone or tablet. The App displays the reading received from the iCOquit® Smokerlyzer® on the smartphone or tablet paired with the device and based on the questions the user answers within the App relating to their smoking habits and the CO reading, they will then receive a result from the Fagerstrom Test of Nicotine Dependence. The sample method for the iCOquit® Smokerlyzer® channels the breath sample exhaled by the user into an integrated breath port on the device. This passes directly over the sensor during the test, ensuring the sensor is exposed to the gas sample for the required length of time to give an accurate reading. The user is required to hold their breath for a 15 second countdown. This is displayed via the iCOquit® App and guides the user through the process of providing a breath sample for measurement. At the end of the breath hold, the patient shall blow gently but fully into the iCOquit, exhaling as much of the breath in their lungs as possible. The reading shown on the App is the peak reading. Once a breath test has been completed the user will be navigated to a screen where they will see their CO result in PPM (parts per million) and %COHb (Carboxyhemoglobin). The reading shown on the App is the peak reading. Users are then asked Fagerstrom questions to determine their smoking status of either low, moderate or high and the result is then saved in a graph. The level of CO measured in PPM is also calculated as %COHB and displayed in the App.

The provided text describes the iCOquit® Smokerlyzer® device and its comparison to a predicate device. Here's a breakdown of the acceptance criteria and the study details:

1. A table of acceptance criteria and the reported device performance

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The Pivot Breath Sensor is a breath carbon monoxide monitor intended for single-user use by cigarette smokers as an educational and motivational tool to inform the user about how breath carbon monoxide levels are affected by smoking behavior. The device is not intended to be used with other combustible, inhaled products.

The Pivot Breath Sensor is a personal, portable, lithium ion battery powered breath carbon monoxide ("CO") monitoring device that measures the level of CO in an individual's exhaled breath. It is intended for single-user over-the-counter ("OTC") use by cigarette smokers (users) to measure CO levels in their exhaled breath. This parameter correlates closely with carboxyhemoglobin levels and with cigarette smoking behavior. Hence, the more a person smokes, the higher are their exhaled breath CO levels. The user submits a breath sample by exhaling (blowing) into the mouthpiece of the Pivot Breath Sensor which is directed over electrochemical sensors to quantify the CO level in the breath. The sensor has two buttons - a front, center button and a side button - to help with user inputs and navigation. It also has a rechargeable battery that can be charged using a micro-USB cable by plugging into USB compatible charging sources such as a computer, USB adapter for power outlet, or car USB port. The calculated CO concentration/ level of the exhaled breath is displayed to the user in whole number parts-per-million ("ppm") on the LCD screen of the sensor. The Pivot breath sensor measures and displays CO concentrations from 0 to 100 ppm. Each of the breath sample results is shown to the user with a corresponding color and a number. The color is intended to aid in giving context to the quantitative CO value, aligning with the predicate device's color coding and scientific literature. The sensor can display multiple samples as the CO log and helps to graphically show the user their relative levels of exhaled breath CO throughout the day and between days. Hence, periodic measurements of CO levels may provide users with feedback regarding their smoking exposure, thus helping them to become educated and motivated to quit smoking, as supported by reference literature.

The provided text details the 510(k) summary for the Carrot Inc. Pivot Breath Sensor. Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The regulatory document outlines several studies and their success criteria, which act as acceptance criteria.

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

• 18-RP-1061A (Human Factors):
  • Sample Size: 15 subjects.
  • Data Provenance: Prospective, single-center study. The document does not specify the country of origin but implies it was conducted under the direct supervision of Carrot Inc. or a contracted research institution.
• 18-RP-1062A (Comparative Performance):
  • Sample Size: 70 subjects.
  • Data Provenance: Prospective, single-center study. No country of origin is specified.
• 20-RP-1083A (Expanded Indications):
  • Sample Size: 234 subjects, split into two cohorts (40-60% smoking 10-19 CPD, 40-60% smoking 20+ CPD).
  • Data Provenance: Prospective, single-center study. No country of origin is specified.

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

The document does not explicitly state the number or qualifications of experts used to establish ground truth for the test sets in the same way one might describe for an imaging AI device. Instead, the "ground truth" for each study is inherent to its design:

• 18-RP-1061A (Human Factors): The ground truth was the observable ability of untrained lay users to operate the device and interpret results against explicit instructions, likely assessed by study personnel. No specific "experts" are mentioned for establishing ground truth in this context.
• 18-RP-1062A (Comparative Performance): The ground truth was established by a prescription-use CO breath sensor used with guidance by a trained health care professional. This serves as the reference standard against which the Pivot Breath Sensor's performance was compared. The number and qualifications of these healthcare professionals are not specified, but they are implied to be "trained."
• 20-RP-1083A (Expanded Indications): The ground truth was self-reported data from participants regarding their "Stage of Change" for quitting smoking, quit attempts, and reduction in cigarettes per day (CPD) compared to baseline. No external "experts" were used to establish this ground truth; it was based on participant responses.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (like 2+1, 3+1 consensus by multiple readers) typically found in AI imaging studies. The studies described are either:

• Observational (Human Factors): Study personnel observed participants' interactions.
• Comparative Measurement (Comparative Performance): Direct comparison of measurements from two devices.
• Self-Reported Outcomes (Expanded Indications): Based on participant responses and observed changes.

Therefore, "none" in the traditional sense of expert adjudication for diagnostic discrepancies.

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 of human readers with vs. without AI assistance was not done. The Pivot Breath Sensor is a direct-to-consumer device that provides readings to a single user, not an AI system assisting human experts in making a diagnosis.

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

Yes, in the context of this device, the "standalone" performance is effectively the performance of the Pivot Breath Sensor itself.

• The "Sensor Performance" bench tests (accuracy, precision, linearity, cross-sensitivity) are a direct assessment of the device's standalone algorithmic and hardware performance against controlled environments and known gas concentrations.
• The 18-RP-1062A (Comparative Performance) study also assesses the standalone performance of the Pivot Breath Sensor by comparing its readings (taken by self-trained users) to a "prescription-use CO breath sensor submitted with guidance by a trained health care professional." The correlation coefficient of 0.9710 indicates a strong standalone performance in agreement with a reference standard.

7. The Type of Ground Truth Used

• Bench Tests: Controlled laboratory measurements and standards for physical and electrical properties, and established ISO standards for biocompatibility.
• 18-RP-1061A (Human Factors): Observational data of user interaction against predefined criteria for correct operation and interpretation.
• 18-RP-1062A (Comparative Performance): Measurements from a "prescription-use CO breath sensor submitted with guidance by a trained health care professional." This acts as the clinical gold standard for CO breath measurement.
• 20-RP-1083A (Expanded Indications): Self-reported outcomes data from participants regarding their smoking behavior, motivation to quit, and quit attempts.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of an AI/ML algorithm development as one would typically see for complex learning models. Given that the device relies on electrochemical sensors, the "training" analogous to machine learning would typically involve:

• Sensor calibration: Manufacturers perform extensive calibration on sensor batches using known gas concentrations. This is implied by the "Sensor Performance" bench tests covering multiple lots.
• Algorithm development: The internal algorithm that converts sensor signals to ppm readings is developed and refined based on engineering principles and empirical data, not necessarily a separate "training set" in the common AI sense.

Therefore, a specific "training set sample size" as might be used for supervised machine learning is not provided or applicable in the traditional sense for this type of device.

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

As explained above, a distinct "training set" with ground truth in the AI/ML sense is not described. For sensor calibration and algorithm development, the "ground truth" would be established through:

• Known gas concentrations: When calibrating electrochemical sensors, the device is exposed to precise, certified concentrations of carbon monoxide (and potentially interfering gases). These known concentrations serve as the ground truth for fine-tuning the sensor's response curve and the device's internal conversion algorithm.
• Engineering and chemical principles: The fundamental operation of an electrochemical sensor is based on established scientific principles, which guide the development of the algorithms that translate raw sensor signals into ppm values.

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The ToxCO® breath Carbon Monoxide monitor and accessories are used by healthcare professionals to determine levels of Carbon Monoxide (CO) poisoning.

The ToxCO® is a hand held exhaled breath monitor for the detection of Carbon Monoxide on the breath. The battery powered monitor uses an electrochemical sensor, designed to react specifically to carbon monoxide producing an electrical output. The output is then amplified and a microcontroller processes the signal and converts it to a meaningful displayed result on an LCD touch screen. The sample system for the ToxCO® mimics the predicate device channeling the breath sample directly over the sensor during test ensuring the sensor is exposed to the gas sample for the required length of time to give an accurate reading. The ToxCO® Monitor uses a non-patient contacting D-piece™ sampling system, with integrated bacterial and viral filter and a one-way valve, attached directly to the monitor. A patient contacting, single patient use SteriBreath™ mouthpiece is connected to the D-piece™ sampling system to perform a breath sample. The D-piece™ is designed to have minimal dead space and therefore initial dilution of the sample is reduced. The patient is required to hold their breath for a 15 second countdown. This is displayed on the LCD screen of the device. At the end of the breath hold, the patient shall blow gently but fully into the ToxCO®, exhaling as much of the breath in their lungs as possible. The reading on the display shall rise until the peak reading is held on the display. Use of the breath sampling D-piece™ and disposable SteriBreath™ mouthpiece may be impossible if the patient is unconscious or injured. In this event, a modified sampling technique can be used, which consists of a specially constructed face mask sampling system, which allows exhaled breath to be directed to the instrument's sensor for analysis. The Face mask sampling system is a single-use, pre-assembled adapter to enable a breath sample to be taken with a single use face mask, connected to the ToxCO® breath Carbon Monoxide monitor by means of a breath sampling D-piece™. The face mask sampling procedure does not require a 15 second breath hold to be performed before the test can begin. Sampling will last 60 seconds as the %COHb/ppm levels rise and then hold at the peak level. The result will be shown on the LCD monitor screen. The ToxCO® breath Carbon Monoxide monitor and accessories are used by healthcare professionals in medical institutions and healthcare environments where Carbon Monoxide exposure is suspected.

The provided document is a 510(k) summary for the ToxCO® Carbon Monoxide Monitor, focusing on demonstrating substantial equivalence to a predicate device rather than providing a detailed study demonstrating performance against a set of acceptance criteria. Therefore, most of the information requested in your prompt regarding a study that proves the device meets acceptance criteria (such as sample size, data provenance, expert involvement, MRMC study details, training set information) is not available in this document.

However, based on the provided text, I can extract information related to the device's accuracy and the performance testing conducted.

Here's an attempt to answer your questions based only on the provided document:

Acceptance Criteria and Reported Device Performance

The document states accuracy as an acceptance criterion.

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: The document does not specify a "sample size" in terms of subject counts for clinical testing. For bench testing, it mentions "calibrated CO gases (0, 20, 50, 158, 605 ppm)" for accuracy and repeatability, and "calibrated CO gases (0, 20, 50, 158, 500, 605 ppm)" for temperature range testing. For facemask mode, it used "calibrated CO gases (0 (clean air), 50, 158, 605 ppm)". These are gas concentrations, not human subjects or a number of tests/runs.
• Data Provenance: Not specified. The manufacturer is Bedfont Scientific Ltd, located in the United Kingdom. Given the nature of the tests described (bench testing with calibrated gases, electrical safety, EMC, software V&V), these are typically laboratory-based tests rather than human subject clinical studies requiring patient data provenance. The document indicates "non-clinical data" was provided.

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 device performance tests (accuracy, range, etc.) was established using calibrated CO gases and a calibrated Volume/Flow simulator, not human expert consensus.

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

• Not applicable. This is not a study involving human readers or subjective interpretations requiring adjudication. Performance was measured against objective standards and calibrated reference instruments.

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. This is a CO monitor, not an AI-assisted diagnostic imaging device. No MRMC study was described or performed.

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

• While the device has software (firmware), the accuracy testing described is on the integrated system (device + sensor + software) measuring CO levels. It's essentially a "standalone" device performance test, as there's no "human-in-the-loop" component determining the CO reading itself (humans interpret the device's output, but the device provides the raw measurement).

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

• The ground truth for the performance testing (accuracy, range, repeatability) was established using calibrated CO gases and a calibrated Volume/Flow simulator representing known concentrations and simulated physiological conditions.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that requires a distinct "training set" for an algorithm. The device functions based on an electrochemical sensor and internal processing, not a trained AI model from external data.

9. How the ground truth for the training set was established

• Not applicable, as there is no "training set" in the context of an AI/machine learning model.

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For monitoring of carbon monoxide in adult exhaled breath. They are in smoking cessation programs and can be used for the screening of CO poisoning and smoke inhalation. Also can be used for ambient air monitoring. For use by healthcare professionals only in professional healthcare facilities.

The Carbon monoxide monitors (CO Check Pro & CO Screen) are hand held, battery powered, carbon monoxide analyzers, used for monitoring the concentration of carbon monoxide in adult exhaled breath, typically for use in smoking cessation programs and for the screening of CO poisoning.

The devices are controlled via a two button kevpad with the measured parameters displayed on a simple LCD with coloured lights and an accompanying buzzer sound in response to the CO level.

Electrochemical sensor technology is utilized to sample the gas and a microprocessor converts the output from the sensor into a meaningful displayed result, either as carbon monoxide in parts per million (CO) or the percentage of carboxyhaemoglobin in the blood (%COHb).

The breath sampling system that attaches directly to the carbon monoxide monitors, comprises of a non-patient contacting mouthpiece adapter incorporating a one way valve to prevent cross contamination and a single use, patient contacting cardboard mouthpiece. The mouthpiece adapter maybe replaced or reused as required.

The Carbon monoxide monitors are supplied non sterile for use by healthcare professionals only and can also be used for ambient air monitoring.

Here's a breakdown of the acceptance criteria and study information for the Carbon Monoxide monitors (CO Check Pro & CO Screen) as described in the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The reported device performance for accuracy is stated as "within +/- 2ppm for each measurement point" for both devices, even though the CO Screen has an acceptance criterion of +/-3%. This implies that the CO Screen also met the stricter +/-2ppm criteria during testing.

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

The document does not explicitly state the sample size for the test set used in the performance testing.
The data provenance is retrospective, as it refers to performance testing conducted by the manufacturer to support the 510(k) submission. The country of origin for the data is not explicitly stated for the performance testing itself, but the manufacturer is based in the United Kingdom.

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

This information is not applicable in this context. The "ground truth" for the performance testing was established using known calibrated gases rather than expert interpretation of patient data.

4. Adjudication Method for the Test Set:

This information is not applicable. The ground truth was based on objective measurements from calibrated gases.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was NOT done. This type of study is typically performed for AI-powered diagnostic devices where human readers interpret medical images or data. This device is a direct measurement instrument, not an AI interpretation system.

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

Yes, a standalone performance evaluation was done. The performance testing described (gas performance testing, temperature testing, packaging testing) assesses the device's accuracy and functionality independently of human interaction for interpretation purposes. The device directly measures CO levels.

7. The Type of Ground Truth Used:

The type of ground truth used was objective measurements from known calibrated gases for assessing accuracy. For temperature and packaging testing, the ground truth was the expected functional performance under specific environmental and physical stress conditions.

8. The Sample Size for the Training Set:

This information is not applicable. This device is a hardware-based carbon monoxide monitor using electrochemical sensor technology and a microprocessor for conversion. It is not an AI/machine learning algorithm that requires a "training set" in the traditional sense.

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

This information is not applicable as there is no "training set" for this type of device. The device's operation is based on its sensor and programmed algorithms, not on learning from a dataset.

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The Carbon Monoxide Breath Sensor System (COBSS) is a breath carbon monoxide monitor intended for single-user use by cigarette smokers in smoking cessation programs to inform the user about how breath carbon monoxide levels are affected by smoking behavior. The device is not intended to be used with other inhaled products.

The Carbon Monoxide Breath Sensor System (COBSS) is a breath carbon monoxide ("CO") monitor intended for single-user over-the-counter ("OTC") use by smokers in smoking cessation programs. The COBSS is a portable, battery-powered device that is composed of the following:

• . CO Breath Sensor. A personal mobile breath sensor capable of measuring the level of CO in exhaled breath.
• . Breath Sensor App. A smart phone app which displays the exhaled breath CO value to the user.

The CO Breath Sensor pairs to the Breath Sensor Application ("BSA") on the smartphone via low-energy Bluetooth. Once paired, the CO Breath Sensor communicates exclusively with the user's phone and is invisible to other devices. The primary screen for the BSA is the CO Log where the most recent exhaled breath CO value in parts-per-million ("ppm") is displayed at the top of the screen. The CO measurements are color coded according to the CO level, and the length of the bar is associated with the ppm value to graphically show the user their relative levels of exhaled breath CO throughout the day and between days.

The Carbon Monoxide Breath Sensor System (COBSS) is a breath carbon monoxide monitor intended for single-user use by cigarette smokers in smoking cessation programs to inform the user about how breath carbon monoxide levels are affected by smoking behavior.

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 document does not explicitly list acceptance criteria in a quantitative table format. However, it implies acceptance through the comparative performance study results and the conclusion of substantial equivalence. Based on the provided text, the implied acceptance criteria were:

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

• Sample Size for Test Set: 70 lay users.
• Data Provenance: The study was a "prospective, open label, single center design." The participants comprised adult smokers, representative of the intended COBSS user profile. The country of origin of the data is not explicitly stated, but given the FDA submission, it is likely the study was conducted in the US.

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

The concept of "ground truth" for the test set is slightly different in this context. The study did not establish a ground truth through expert consensus on CO levels. Instead, it used a predicate device (Micro+ Smokerlyzer) administered by trained personnel as the reference standard for comparative performance. The document states that the predicate device was "submitted with guidance by a health care professional trained in the use of the device." The number and specific qualifications of these "health care professionals" are not detailed beyond "trained in the use of the device."

4. Adjudication Method for the Test Set

There was no explicit adjudication method described for the test set in terms of resolving discrepancies between multiple readers or experts. The comparison was primarily between the COBSS used by lay users and the predicate device used by trained personnel.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study as typically defined for imaging diagnostics (comparing multiple readers' interpretations with and without AI assistance on multiple cases) was not conducted. This study focused on the performance of the device itself (both standalone and with lay users) compared to a predicate, and the usability of the device by lay users. It assessed the ability of lay users to use the device without assistance compared to trained personnel using the predicate device.

• Effect size of human readers improving with AI vs. without AI assistance: Not applicable, as this was not an MRMC study comparing human performance with and without AI assistance. Instead, it compared the COBSS with untrained lay users to a predicate with trained healthcare professionals.

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

Yes, a standalone performance component was conducted through bench testing. This testing evaluated:

• Sensor performance (accuracy, precision, linearity, H2 Cross Sensitivity)
• Interfering Gases
• Device Use Testing
• Shelf Life/Sensor Drift

These tests evaluate the intrinsic performance of the sensor and device system without human interaction for measurement acquisition or interpretation.

7. Type of Ground Truth Used

The "ground truth" for the comparative performance study was the measurements provided by the predicate device (Micro+ Smokerlyzer) when administered by trained healthcare professionals. This is a form of reference standard comparison against an already cleared and accepted medical device.

8. Sample Size for the Training Set

The document does not provide information on the sample size used for the training set for the COBSS device. This is common for devices of this type where the core technology might be based on established electrochemical sensing, and the "training" may refer more to calibration and validation of the sensor hardware and associated algorithms rather than a conventional machine learning training set with labeled data.

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

Given the lack of information on a "training set" and its size, how ground truth for it was established is also not provided. For sensor-based devices, "ground truth" during development often involves:

• Controlled gas mixtures with known CO concentrations.
• Comparison against highly accurate laboratory reference instruments.
• Characterization of sensor response across its specified range and environmental conditions.

The document mentions "bench testing" which would likely involve such methods for calibrating and validating the sensor's fundamental performance characteristics. However, explicit details on training data ground truth are absent.

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The CoSense ETCO Monitor is indicated for the monitoring of carbon monoxide from endogenous sources (including hemolysis) and exogenous sources (including CO poisoning and smoke inhalation) in exhaled breath. The end tidal carbon monoxide level can be used for the monitoring of carbon monoxide in medical conditions in which the rate of hemolysis may be relevant. It is also for use in smoking cessation programs and can be used for the screening of CO poisoning and smoke inhalation.

The CoSense ETCO Monitor is a battery-operated carbon monoxide (CO) monitor. It uses an infrared capnometer to detect the end-tidal portion of the breath and an electrochemical carbon monoxide sensor to measure the end-tidal breath CO concentration. The device consists of a portable unit with software controlled menu (date, time, patient identification, measurement time of monitoring), single-use nasal cannula, replaceable CO Sensor, and a battery charger / power supply.

This document is a 510(k) premarket notification for the Capnia CoSense ETCO Monitor. It seeks to demonstrate substantial equivalence to a predicate device (K130036), which is also a Capnia CoSense ETCO Monitor.

The submission focuses on the argument that the "design and performance specifications are identical and unchanged from our predicate device." Modifications primarily involved a heating element, cannula configuration, flow rate sensor, and software updates, which the manufacturer states do not alter performance specifications or intended use.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document explicitly states that the subject device shares "identical performance specifications (accuracy, range, and resolution)" with the predicate device. Therefore, the acceptance criteria are implicitly that the subject device maintains these identical specifications.

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

The document does not provide specific sample sizes for a separate test set used to evaluate the subject device's performance against the predicate. Instead, it states that "representative samples of the device underwent biocompatibility (Cytotoxicity, Sensitization, and Irritation), software, electrical, and mechanical testing, specifically CO Measurement accuracy." The provenance of this data is not specified (e.g., country of origin, retrospective or prospective).

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. The study appears to rely on established performance specifications rather than a new ground truth established by experts for this specific 510(k) submission.

4. Adjudication method for the test set:

This information is not provided.

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:

This is not applicable to the CoSense ETCO Monitor. It is a carbon monoxide monitor, not an AI-assisted diagnostic imaging or interpretation device.

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

This is not directly applicable in the context of an "algorithm only" study as it is a medical device for direct measurement. The "software" was tested, but not as a standalone AI algorithm in the typical sense. The device itself is designed for standalone operation (measuring CO in exhaled breath).

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

For the performance specifications of the device (both subject and predicate), the implied ground truth would be precise measurements from calibrated gas analyzers for CO concentration. However, this document does not detail how these original performance specifications for the predicate were established, only that the subject device maintains them.

8. The sample size for the training set:

This is not an AI/machine learning device in the context of a "training set" as typically used for AI model development. Therefore, this information is not applicable and not provided.

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

Not applicable, as it's not an AI/machine learning device with a training set.

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The CoSense ETCO Monitor is indicated for the monitoring of carbon monoxide from endogenous sources (including hemolysis) and exogenous sources (including CO poisoning and smoke inhalation) in exhaled breath. The end tidal carbon monoxide level can be used for the monitoring of carbon monoxide in medical conditions in which the rate of hemolysis may be relevant. It is also for use in smoking cessation programs and can be used for the screening of CO poisoning and smoke inhalation.

The CoSense ETCO Monitor is a battery-operated carbon monoxide (CO) monitor. It uses an infrared capnometer to detect the end-tidal portion of the breath and an electrochemical carbon monoxide sensor to measure the end-tidal breath CO concentration. The device consists of a portable unit with software controlled menu (date, time, patient identification, measurement time of monitoring), single-use nasal cannula, replaceable CO Sensor, and a battery charger/power supply.

The CoSense ETCO Monitor is a carbon monoxide (CO) monitor that uses an infrared capnometer to detect the end-tidal portion of the breath and an electrochemical carbon monoxide sensor to measure the end-tidal breath CO concentration.

Here's an analysis of its acceptance criteria and the study that proves it:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance:

• Test Set Sample Size: Not explicitly reported as a human test set. The submission relies on the identical performance specifications of its predicate device, K121768, and a clinical data analysis of published studies on other FDA-cleared CO monitoring devices.
• Data Provenance: The study performed an "analysis of published clinical data" on "uses of other FDA-cleared CO monitoring devices." This suggests the data is retrospective and collected from existing literature and studies, likely covering various clinical sites and geographical locations if the published data is diverse. No specific country of origin is mentioned for this retrospective analysis.

3. Number of Experts and Qualifications:

• Not applicable for establishing ground truth for a test set, as the study relied on an analysis of published clinical data on other devices and the identical performance specifications to a predicate device. The performance specifications themselves would have been established through engineering and laboratory testing, rather than expert interpretation of a specific test set.

4. Adjudication Method:

• Not applicable as the study did not involve a human-in-the-loop test set requiring expert adjudication.

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

• No. The submission does not describe an MRMC comparative effectiveness study for the subject device. It focuses on demonstrating equivalence to predicate devices and analyzing existing published clinical data.

6. Standalone Performance:

• Yes. The device's performance specifications (accuracy, range, resolution) are presented as "identical" to its predicate (Capnia CoSense CO Monitor K121768) and "similar" to a reference predicate (Natus CO-STAT End Tidal Breath Analyzer K974805), indicating a standalone assessment of the device's technical specifications. The submission states, "The CoSense ETCO Monitor uses the identical performance specifications (accuracy, range, and resolution), software algorithms, sensors, and accessories as our predicate device, the CoSense CO Monitor."

7. Type of Ground Truth Used:

• The ground truth for the performance specifications (accuracy, range, resolution) are established through objective measurements against known standards, typical for medical device engineering and testing.
• For the "analysis of published clinical data," the "ground truth" would be the clinical outcomes and CO measurements reported in those studies, which are assumed to be established by the methodologies used in the respective published research. The submission states this analysis provides "objective evidence that the functional and performance specifications of CoSense device are similar to the devices in the published studies."

8. Sample Size for the Training Set:

• Not applicable. This device is primarily hardware with established performance specifications. The "software algorithms" are stated to be "identical" to the predicate, implying they were developed and "trained" (if machine learning was involved, which is unlikely for this type of device based on the description) during the development of the predicate device. No details are provided on a specific training set for the subject device.

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

• Not applicable, as no training set for the subject device is described. The ground truth for the underlying performance of the electrochemical sensor and capnometer would have been established through precise laboratory calibration and gas measurement standards.

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The CoSense CO Monitor is indicated for the monitoring of Carbon Monoxide from endogenous and exogenous sources in exhaled breath. It is for use in smoking cessation programs and can be used for the screening of CO poisoning and smoke inhalation. It is for use by health professionals.

The CoSense CO Monitor is a battery-operated carbon monoxide monitor. It uses an infrared capnometer to detect the end-tidal portion of the breath and an electrochemical carbon monoxide sensor to measure the end-tidal breath CO concentration. The device consists of a portable unit with software controlled menu (date, time, patient identification, measurement time of monitoring), single-use nasal cannula, replaceable CO Sensor, and a power supply.

The provided text describes the CoSense™ CO Monitor, its indications for use, and a 510(k) summary for its clearance. However, it does not contain details about specific acceptance criteria related to device performance (e.g., accuracy, precision) or a study that directly proves the device meets such criteria.

The document primarily focuses on:

• Regulatory Clearance: Listing the device's classification, product code, and predicate device.
• Device Description: Explaining how the monitor works.
• Intended Use: Defining its applications.
• Functional and Safety Testing: Mentioning adherence to industry standards for biocompatibility, software, electrical, and mechanical aspects. This testing verifies that the design meets its functional and performance requirements generally, but specific performance metrics (e.g., measurement accuracy against a gold standard) are not detailed here.
• Substantial Equivalence: Concluding that the device is equivalent to a predicate based on similarities in indications, operation, technology, and materials. This is a regulatory conclusion, not a performance study result.

Therefore, I cannot fulfill all parts of your request with the provided information. I will address the points that can be answered and clearly state where information is missing.

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific numerical acceptance criteria (e.g., accuracy thresholds, precision values) for the device's CO measurement performance, nor does it provide a table of reported device performance metrics in terms of CO measurement accuracy or precision that would typically be found in a performance study.

The "Acceptance Criteria" mentioned are for functional and safety testing (biocompatibility, software, electrical, and mechanical testing against specific industry standards). The reported device performance in this context is simply the conclusion that the device meets these standards.

2. Sample size used for the test set and the data provenance

Not provided in the text. The document mentions "representative samples of the device underwent testing," but does not specify the number of devices, patients, or measurements used for any testing directly related to CO measurement performance.

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

Not applicable/Not provided in the text. This type of information is typically relevant for medical imaging or diagnostic algorithms where expert consensus is used to establish ground truth for a disease state. For a carbon monoxide monitor measuring a physiological parameter, the "ground truth" would typically involve a reference standard CO measurement device or gas concentration, not human expert interpretation of the device's output.

4. Adjudication method for the test set

Not applicable/Not provided in the text. See point 3.

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/Not provided in the text. An MRMC study is not relevant for a CO monitor. The device's function is to objectively measure CO, not to assist human readers in interpreting complex medical images or data.

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

The device itself is a standalone monitor (algorithm only without human-in-the-loop performance in terms of interpreting its raw output). The document implies that the device's measurement capability was evaluated, but details of a specific "standalone" performance study (e.g., accuracy against a known CO source) are not detailed in the provided text. The functional and safety testing ensures the device operates correctly, but specific performance metrics are absent.

7. The type of ground truth used

For objective measurements like CO concentration, the ground truth would typically be an independent, highly accurate reference standard method for measuring CO or certified gas mixtures. The provided text does not specify what ground truth method was used for performance validation of the CO measurement capabilities, but it would not be "expert consensus" or "pathology" for this type of device.

8. The sample size for the training set

Not applicable/Not provided in the text. The CoSense CO Monitor is described as using an infrared capnometer and an electrochemical CO sensor. This suggests it's a sensor-based measurement device rather than a machine learning model that would require a "training set" in the conventional sense (e.g., for image recognition or predictive analytics). While the device has "software controlled menu," it's not explicitly stated to be an AI/ML device requiring a training set for its core measurement function.

9. How the ground truth for the training set was established

Not applicable/Not provided in the text. See point 8.

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The TABATABA® CO TESTER is for the monitoring of Carbon Monoxide in exhaled breath. It is for use in smoking cessation programs and can be used for the screening of CO poisoning and smoke inhalation. It can also be used for ambient air monitoring. It is for use by health professionals.

The TABATABA is a battery operated hand held carbon monoxide monitor for use as an aid in smoking cessation programs. The TABATABA is a complete tool for the prevention of the risks of active or passive smoking. It can be carried in the pocket or on the belt. The device is parametered by an internal menu (time, date, alarm threshold, measurement time of monitoring). It can be connected to a computer via an RS232 port, to record and analyze results.

The provided text describes the TABATABA® CO TESTER, a Carbon Monoxide gas analyzer, and its substantial equivalence to a predicate device (K000962. PiCO Smokerlyzer, Bedfont Scientific Ltd.). The information primarily focuses on a comparison of characteristics rather than a detailed study with specific acceptance criteria and performance metrics typically found for AI/ML devices.

Based on the provided text, a direct table of "acceptance criteria" and "reported device performance" in the context of an AI/ML study is not available. The document is a 510(k) summary for a medical device, which typically establishes substantial equivalence to a predicate device based on similar intended use, technological characteristics, and safety/effectiveness data.

Here's an analysis of the provided information, addressing your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state "acceptance criteria" in a quantitative manner for performance metrics like sensitivity, specificity, or AUC, as would be common for AI/ML studies. Instead, it relies on demonstrating substantial equivalence to a predicate device. The "performance" is implicitly demonstrated through bench, standards, and clinical testing showing it's "as safe and effective" as the predicate.

The table below reflects the comparison of characteristics, which served as the basis for the substantial equivalence claim. The "Acceptance Criteria" here are the characteristics of the predicate device that the TABATABA® CO TESTER needed to meet or be comparable to. The "Reported Device Performance" refers to the TABATABA® CO TESTER's characteristics.

Study Proving Device Meets Acceptance Criteria:

The document states that "The results of bench, standards, and clinical testing indicates that the new device is as safe and effective as the predicate devices," and thus supports the conclusion of substantial equivalence. However, the details of these tests are not provided in this summary.

Regarding AI/ML specific questions (which are not directly applicable to this device based on the provided information):

2. Sample size used for the test set and the data provenance: Not applicable as this is not an AI/ML device. The document mentions "clinical testing data" without specifying sample size or provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is not an AI/ML device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as this is not an AI/ML device.
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 as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is not an AI/ML device. The device is a direct measurement tool.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For a CO analyzer, the "ground truth" would typically be established by highly accurate laboratory-grade CO measurement instruments. The document doesn't specify the method, but mentions "bench, standards, and clinical testing."
8. The sample size for the training set: Not applicable as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable as this is not an AI/ML device.

In summary: The K080278 submission is for a traditional medical device (CO analyzer) and demonstrates substantial equivalence to a predicate device. It does not involve AI/ML technology, and therefore, many of the questions related to AI/ML study design are not applicable to the information provided. The "acceptance criteria" were the characteristics and performance of the predicate device, which the new device aimed to match or improve upon while remaining substantially equivalent. The study mentioned ("bench, standards, and clinical testing") served to demonstrate this equivalence, although specific data from these studies are not detailed in this summary.

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