(364 days)
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.
| Metric (Implied Acceptance Criteria) | Reported Device Performance (Clinical Precision Study) |
|---|---|
| Clinical Precision (Within Subject) | |
| 0 to =50 ppb FeNO | Mean SD: 1.4078969 ppb; Mean CV: 1.89% (95% CI: 1.29%; 2.48%) |
| Clinical Efficacy (FeNO Change with Therapy) | |
| Mean change in FeNO after corticosteroids | -13.7 ppb (-27.7%) with a mean SD of 17.8 (for patients with elevated baseline FeNO - ATS >25ppb for adults, >20ppb for children) |
| ACQ (Asthma Control Questionnaire) score change | Fell by -29.7% after corticosteroids (secondary outcome) |
| FEV1 (Forced Expiratory Volume in 1 second) change | Mean 10.1% change after corticosteroids (secondary outcome) |
Study Details:
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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.
- Clinical Precision Study (Test Set):
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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.
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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.
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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.
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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.
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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.
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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."
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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.
§ 862.3080 Breath nitric oxide test system.
(a)
Identification. A breath nitric oxide test system is a device intended to measure fractional nitric oxide in human breath. Measurement of changes in fractional nitric oxide concentration in expired breath aids in evaluating an asthma patient's response to anti-inflammatory therapy, as an adjunct to established clinical and laboratory assessments of asthma. A breath nitric oxide test system combines chemiluminescence detection of nitric oxide with a pneumotachograph, display, and dedicated software.(b)
Classification. Class II (special controls). The special control is FDA's guidance entitled “Class II Special Controls Guidance Document: Breath Nitric Oxide Test System.” See § 862.1(d) for the availability of this guidance document.