(569 days)
Fenom Pro is a portable, non-invasive device to measure fractional exhaled nitric oxide (FENO) in human breath. FENO is increased in some airway inflammatory processes, such as asthma, and decreases in response to anti-inflammatory treatment. Fenom Pro measures fractional exhaled nitric oxide according to guidelines established by the American Thoracic Society.
Measurement of FENO by Fenom Pro is a non-invasive quantitative 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 therapeutic effect in patients with elevated FENO measurements are to be used as an adjunct to established clinical assessments. Fenom Pro is suitable for adults and children 6 years and older.
Fenom Pro should be used in a point-of-care healthcare setting under professional supervision. Fenom Pro should not be used in critical care, emergency care or in anesthesiology.
Fenom Pro is a non-invasive point-of-care breath analyzer for the quantitative measurement of fractional exhaled nitric oxide (FENO) in expired human breath.
Fenom Pro is comprised of four major components. The main unit contains a touch screen interface for the user and houses the nitric oxide sensor and pneumatics needed to sample the patient's breath. The patient exhales into the Fenom Pro though a single use disposable mouthpiece which is attached to the handpiece. The handpiece is connected to the main unit via a breath tube.
For testing, the patient inhales to total lung capacity and then slowly exhales into the mouthpiece for 6 or 10 seconds, depending on the mode of operation. Approximately 28 seconds after a successful breath maneuver, the FENO concentration is displayed in parts per billion (ppb) on the device touch screen. The device has a daily quality control procedure to ensure consistent device performance.
The Fenom Pro device, a breath nitric oxide test system, was evaluated for performance against specified acceptance criteria.
- Table of Acceptance Criteria and Reported Device Performance:
| Criteria | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Precision | 50 ppb. | 50 ppb. |
| Accuracy | ± 5 ppb NO for concentrations ≤50 ppb. ± 10% for NO concentrations >50 ppb. | ± 5 ppb NO for concentrations ≤50 ppb. ± 10% for NO concentrations >50 ppb. |
| Linearity | Slope: 1.0 ± 0.05, r2: ≥ 0.998 | Slope: 1.0 ± 0.05, r2: ≥ 0.998 |
| Detection Level | 10 ppb | 10 ppb |
| Measurement Range | 10-200 ppb NO | 10-200 ppb NO |
| Analysis Time | Approximately 30 seconds | Approximately 30 seconds |
| Breath Sample Conditioning | Not explicitly stated as acceptance criteria, but a difference in technology was noted compared to the predicate | Not explicitly stated as accepted, but the device's technological difference is "None" compared to predicate's "Reduced humidity" |
| Test Principle | Not explicitly stated as acceptance criteria, but a difference in technology was noted compared to the predicate | Not explicitly stated as accepted, but the device uses "Amperometric Sensor Technology" compared to predicate's "Potentiometric Sensor Technology" |
| Measurement Mode | Not explicitly stated as acceptance criteria, but a difference in technology was noted compared to the predicate | Not explicitly stated as accepted, but the device has "6 second and 10 second breath maneuver" compared to predicate's "10 second breath maneuver" |
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Sample size used for the test set and data provenance:
- The document states that "Clinical studies were performed to evaluate the clinical precision and clinical accuracy of the candidate device." However, specific sample sizes for these clinical studies are not provided in the summary.
- The provenance of the data (e.g., country of origin, retrospective or prospective) is not explicitly mentioned.
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Number of experts used to establish the ground truth for the test set and their qualifications: Not provided in the summary.
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Adjudication method for the test set: Not provided in the summary.
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Multi-Reader Multi-Case (MRMC) comparative effectiveness study: No MRMC study was mentioned. The device measures fractional exhaled nitric oxide (FENO) which is a quantitative measurement, not typically subject to subjective interpretation by multiple human readers in the same way as imaging studies. The indications for use state that FENO measurements are to be used as an adjunct to established clinical assessments, implying a standalone measurement rather than an AI-assisted human reading.
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Standalone (algorithm only without human-in-the-loop performance) study: Yes, the device is described as measuring FENO quantitatively. The non-clinical and clinical studies performed (precision, accuracy, linearity, etc.) relate to the device's standalone performance in measuring FENO.
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Type of ground truth used: For quantitative measurements like FENO, the ground truth would typically be established by highly accurate reference methods or calibration gases with known nitric oxide concentrations for non-clinical studies. For clinical studies, comparison to a gold standard FENO measurement device or clinical outcomes (e.g., response to anti-inflammatory treatment) would be used to establish clinical accuracy and precision. The summary implies that "studies were performed to evaluate performance with regards to the specificity (interference), precision, accuracy, linearity, effect of temperature and humidity, detection limit and stability" for non-clinical data, and "clinical precision and clinical accuracy" for clinical data. The exact nature of the "ground truth" (e.g., comparison to a specific reference method) for each of these studies is not detailed.
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Sample size for the training set: Not applicable based on the provided information. This device is a measurement system and the information provided does not indicate the use of machine learning models requiring a specific "training set" in the common sense for AI/ML devices.
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How the ground truth for the training set was established: Not applicable, as no training set for an AI/ML model is indicated.
§ 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.