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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 NObreath® is a portable. non-invasive device for the measurement of Fractional Exhaled Nitric Oxide (FeNO) in human breath. The production of nitric oxide is often found to be increased in inflammatory conditions such as asthma. Measurement of FeNO by NObreath® is a method to measure the decrease in FeNO concentration in asthma patients that often occurs after treatment with anti-inflammatory pharmacological therapy, as an indication of the therapeutic effect in patients with elevated FeNO levels.

The fractional NO concentration in expired breath (FeNO), can be measured by NObreath® according to guidelines for NO measurement established by the American Thoracic Society.

NObreath® is intended for children, 7- 17 years, and older. NObreath® 12 second test mode is for age 7 and up

NObreath® 10 second test mode is for ages 7-10 only who cannot successfully complete a 12 second test.

FeNO measurements provide the physician with means of evaluating an asthma patient's response to anti- inflammatory therapy, as an adjunct to the established clinical and laboratory assessments in asthma. The NObreath® cannot be used with infants or by children under the age of 7 as measurement requires patient cooperation.

NObreath® should not be used in critical care, emergency care or in anesthesiology.

NObreath® is a portable system for the non-invasive, quantitative measurement of the fraction of exhaled nitric oxide (NO) in expired human breath (FeNO). The NObreath® system is comprised of the main unit with AC adapter, a rechargeable battery, an electrochemical NO sensor, disposable patient mouthpiece with filter. The device can connect to the PC via a standard USB cable or wirelessly via Bluetooth.

For testing, the patient inhales deeply and slowly exhales for 10 or 12 seconds through the patient filter. In approximately 12 seconds the NO concentration is displayed in parts per billion (ppb). Results are processed using dedicated software. The device has built-in system control procedures and a calibration to be performed every 12 months.

Wireless Bluetooth Low Energy (BLE) is used as a means of communication between the monitor and FeNOchart™ software running on a PC. The FeNOchart™ software is a charting program that retrospectively collects data from the NObreath® monitor when it is not monitoring. It is not time critical, there are no alarms

The provided text describes the NObreath® device, a system for measuring Fractional Exhaled Nitric Oxide (FeNO). There is no acceptance criteria table or information related to an AI/ML-driven device in the provided text. The document is a 510(k) premarket notification summary for a medical device (NObreath®) which directly measures NO using an electrochemical sensor. Therefore, the questions related to AI/ML specific criteria (such as ground truth establishment for training, or MRMC studies) are not applicable to this device submission.

However, based on the information provided, here's a breakdown of the device's performance and supporting studies:

No acceptance criteria table for AI/ML device is provided, as this is not an AI/ML device.

The device performance data is presented as part of the clinical precision study.

Acceptance Criteria and Reported Device Performance (Table Based on Clinical Precision Study)

The "acceptance criteria" for a traditional medical device like NObreath® would typically be specified in terms of its analytical performance (accuracy, precision, measurement range, limit of detection) and clinical performance (how well it measures FeNO in a clinical setting). The document highlights the device's clinical precision.

Study Details:

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

   • Clinical Precision Study (Test Set):
     • Sample Size: 76 participants (24 pediatric, ages 7-17 years; 52 adults, 18+ years).
     • Data Provenance: Not explicitly stated, but given the sponsor (Bedfont Scientific Ltd) is based in England, the study was likely conducted in the UK or a similar regulatory environment. The study is retrospective in the sense that the data was collected for evaluation, but the measurements themselves are prospective in nature taken at the time of the study.
   • Clinical Efficacy Study (Longitudinal Study):
     • Sample Size: 186 patients (95 adults, 18+ years; 91 children, 7-17 years).
     • Data Provenance: Not explicitly stated, but likely from the same geographical region as the sponsor. This was a prospective longitudinal study with measurements at baseline and 2 weeks later.

2. Number of experts used to establish the ground truth for the test set and qualifications of those experts (e.g. radiologist with 10 years of experience):

   • This is not an AI/ML device, so "ground truth" for image interpretation by experts is not applicable in the typical sense.
   • For the clinical precision study, the device's own measurements are being evaluated for their agreement. "Ground truth" here is less about expert interpretation and more about the inherent biological variation and device measurement variability. The study involved the assistance of three healthcare professionals (HCPs) for collecting the six FeNO evaluations per participant, suggesting their role in operating the device and ensuring proper technique rather than establishing a diagnostic ground truth. Their qualifications are not specified beyond "HCPs."
   • For the clinical efficacy study, the "ground truth" for the effectiveness of a therapeutic agent (corticosteroids) is established by the observed fall in FeNO measurements by the device itself, alongside changes in established clinical and laboratory assessments (ACQ score, FEV1). These are objective clinical measures rather than expert consensus on a subjective interpretation.

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

   • Not applicable as this is not an AI/ML device requiring adjudication of interpretations. The clinical precision study aimed to capture user bias but not through an adjudication process of diagnostic outputs. Each participant had six measurements taken by HCPs, and the data was analyzed for within-subject precision.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No, this is not an AI-assisted device, so an MRMC study comparing human readers with and without AI assistance was not performed.

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

   • This is a standalone diagnostic device. The performance data presented (precision and efficacy) are "standalone" in the sense that they represent the device's ability to measure FeNO. Human interaction is required for operation (patient breathing into the device, HCPs assisting), but there isn't an algorithm that operates independently to provide a diagnostic output without direct human interaction in the measurement process.

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

   • For Clinical Precision: The "ground truth" is typically the true underlying FeNO concentration, which is approximated by repeated measurements from the device itself. The study design acknowledges variability and aims to quantify it. It's more about characterizing instrument performance than a singular "truth" established by an external reference.
   • For Clinical Efficacy: The "ground truth" for demonstrating efficacy of FeNO measurement in monitoring therapy response is the physiological change in FeNO levels and correlation with established clinical outcomes data (ACQ, FEV1) following therapeutic intervention. This is an outcomes-based approach in a clinical trial context.

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device that requires a training set in the sense of machine learning. The device's electrochemical sensor and internal algorithms are based on established physical and chemical principles and traditional engineering calibration, not data-driven learning from a "training set."

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

   • Not applicable. As above, there is no AI/ML training set. The device would be calibrated using known gas concentrations, with precision and accuracy validated through bench testing using reference standards and then clinically validated.

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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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The EC50 ToxCO+ Breath Carbon Monoxide Monitor and accessories are used by healthcare professionals to determine levels of Carbon Monoxide (CO) poisoning.

The EC50 ToxCO+ Breath Carbon Monoxide Monitor is a handheld device, which provides a non-invasive means of determining Carbon Monoxide (CO) poisoning and Carboxyhaemoglobin (COHb) when blood testing is not available. The EC50 ToxCO+ Breath Carbon Monoxide Monitor is also ideal for use during triage to ensure suspected cases of CO poisoning are not missed. The EC50 ToxCO+ Breath Carbon Monoxide Monitor is a microprocessor-controlled device powered by 2 AA batteries with an Alphanumerice LCD display housed in a sturdy ABS case with a synthetic rubber boot. The EC50 ToxCO+ Breath Carbon Monoxide Monitor is designed to have an operating temperature between 0-30° C, operating humidity 10-95% non-condensing and has storage temperature requirements of 0-30° C. The sensor sensitivity is 1 pmm, has a warm up time of

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

Device: EC50 ToxCO+ Breath Carbon Monoxide Monitor

1. Table of Acceptance Criteria and Reported Device Performance

The provided documentation does not explicitly define a formal "acceptance criteria" table with specific thresholds that the device must meet to be deemed acceptable. Instead, it relies on comparison to predicate devices and reported specifications.

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