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Fenom Pro™ Nitric Oxide Test 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 often decreases in response to anti-inflammatory treatment of FeNO by Fenom Pro™ 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 therapeutic effect in patients with elevated FeNO levels. FeNO measurements are to be used as an adjunct to established clinical assessments. Fenom Pro™ is suitable for children, approximately 7-17 years, and adults 18 years and older.

Testing using the Fenom Pro™ should only be done 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 point-of-care breath analyzer that uses solid-state electrochemical technology to measure the fraction of exhaled nitric oxide (FeNO), a marker for airway inflammation, in human exhaled breath. Measurement of FeNO by Fenom Pro is a quantitative and non-invasive method to indicate therapeutic effects of anti-inflammatory pharmacological therapy in patients with elevated FeNO levels. Fenom Pro™ is suitable for children, approximately 7-17 years, and adults 18 years and older.

Fenom Pro uses solid state, potentiometric, sensor technology sensitive to nitric oxides (NO) compounds. The solid state sensor is fluidly preceded by a reactive filter material that renders (oxidizes) potentially confounding species such as carbon monoxide (CO), ammonia (NH4), and methanol (CH4O) inactive, or inert, to the NO sensor. Fenom Pro provides visual and audible feedback during its use. The visual and audible feedback is especially important during the FeNO measurement such that the user can modulate their breath speed within the flow parameters required by the American Thoracic Society (ATS) and the European Respiratory Society (ERS) standards.

Fenom Pro is comprised of four major components. The main unit contains a touch screen interface for the use as well as houses the nitric oxide sensor and pneumatics needed to sample the patient's breath. The patient interfaces with Fenom though the mouthpiece which is attached to the handpiece. The handpiece is connected to the main unit via a breath tube. The handpiece contains a breath conditioning cartridge which prepares the breath sample from the patient for proper analysis in the main unit. Both the mouthpiece and the breath conditioning cartridge are consumables.

Here's an analysis of the provided text, extracting the acceptance criteria and the study details for the Fenom Pro™ Nitric Oxide Test.

Device: Fenom Pro™ Nitric Oxide Test (K182874)
Intended Use: Portable, non-invasive device to measure fractional exhaled nitric oxide (FeNO) in human breath. FeNO measurements are used as an adjunct to established clinical assessments to indicate therapeutic effect in patients with elevated FeNO levels after anti-inflammatory pharmacological therapy. Suitable for children (approx. 7-17 years) and adults (18+ years).

1. Table of Acceptance Criteria and Reported Device Performance

The provided document details non-clinical (analytical) and clinical studies. We will parse the acceptance criteria and performance from these sections.

Non-Clinical (Analytical) Performance:

Clinical Performance:

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

• Non-Clinical (Analytical):

  • Accuracy and Environmental Testing: 2 devices, 3 concentrations (15, 75, 200 ppb), 5 replicates per concentration, 5 environmental conditions. Total of 150 tests.
  • Precision: 5 devices, 5 operating days, 2 sessions per day, 4 runs per session, 2 replicates per concentration (10, 25, 75, 200 ppb). This calculates to 80 replicates per sample per device according to CLSI EP05-A3.
  • Linearity: 2 devices, 8 NO concentration levels (5, 10, 15, 30, 50, 100, 150, 200 ppb), 5 replicates per concentration. Total 80 tests.
  • Limit of Detection: 2 devices, 0 ppb (60 replicates), 5 ppb (30 replicates), 10 ppb (30 replicates) over three days. Total 120 replicates.
  • Interference (Other Gases): Tested in a laboratory setting. No specific number of tests/replicates provided, but states "The applicable concentration of each substance was generated... and the sensor signal was measured."
  • Interference (Exogenous Substances): Minimum of 10 volunteers per substance (7 substances). This means at least 70 volunteers.
  • Data Provenance: The document does not explicitly state the country of origin for the non-clinical data. It is implied to be laboratory-based and likely retrospective as it's presented as completed tests.

• Clinical:

  • Clinical Precision (User Bias Study): 127 subjects (44 pediatric, 83 adults). Each subject yielded 6 evaluations (2 Fenom Pro measurements with assistance of 3 HCPs). Data provenance not explicitly stated (e.g., country), but implied prospective data collection for this study.
  • Clinical Precision (Within-subject Variability/Longitudinal Study): 82 subjects (37 pediatric, 45 adults). Each subject provided replicate (n=2) FeNO measurements at Visit 1 (baseline) and Visit 2 (after approx. two weeks). Data provenance not explicitly stated, but implied prospective data collection.
  • Clinical Efficacy (Concordance Study): 82 subjects in longitudinal study (matches the precision study's subject count) - 37 pediatric, 45 adults. 80 subjects for regression analysis (due to missing asthma symptom scores for 2 subjects). Data provenance not explicitly stated, but implied prospective data collection.

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

• Non-Clinical Studies:
  • Accuracy, Precision, Linearity, LoD: Ground truth was established using calibrated reference instruments/methods. Specifically, a chemiluminescence device calibrated against a NIST (National Institute of Standards and Technology) traceable NO tank was used to measure the actual concentration of nitric oxide in simulated breath mixtures. This does not involve human experts in the same way as, for example, image interpretation.
  • Interference (Other Gases): Ground truth was based on the controlled generation of specific gas concentrations and measurement by the device.
  • Interference (Exogenous Substances): The ground truth for this was the subjects' baseline Fenom Pro levels before exposure to the substances, acting as their own control for comparison.
• Clinical Studies:
  • Clinical Precision (User Bias Study) and Clinical Precision (Within-subject Variability/Longitudinal Study): The ground truth was effectively the FeNO measurements themselves, as performed by the device. The study evaluated agreement between HCPs and within subjects. The study used three healthcare professionals (HCPs) to assist with measurements. Their specific qualifications (e.g., type of healthcare professional, years of experience) are not provided in the summary.
  • Clinical Efficacy (Concordance Study): The "ground truth" for showing clinical efficacy was the change in FeNO, which was correlated with changes in established asthma-related outcome measures (spirometry - FEV1, and asthma questionnaires - ACQ/pACQ). These established measures themselves serve as the comparative ground truth. The expertise in interpreting FEV1 and ACQ/pACQ would be inherent in the clinicians applying these standard assessments but is not explicitly detailed as part of "ground truth establishment" for the device's performance.

4. Adjudication Method for the Test Set

• Non-Clinical Studies: No adjudication method is applicable as these are instrumental measurements against calibrated standards.
• Clinical Studies: No formal adjudication method involving multiple experts resolving discrepancies is described for the clinical studies. The "user bias" study quantifies bias between HCPs rather than adjudicating a "true" FeNO value. The other clinical studies compare the device's output to standard clinical measures rather than relying on a panel for ground truth adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This device is a breath test system, not an imaging AI system that assists human readers (like radiologists). Therefore, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study focusing on human reader improvement with AI assistance is not applicable to this device.

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

The Fenom Pro™ is a point-of-care device that directly measures FeNO. Its non-clinical (analytical) performance tests (Accuracy, Precision, Linearity, LoD, Interference) are essentially standalone performance of the device's measurement algorithm/sensor. While human operators perform the physical test, the output (FeNO value) is generated by the device's internal algorithms from the sensor data, without human interpretation or intervention in the measurement result itself.

The "user bias" clinical study specifically explores human-in-the-loop variance (i.e., how different operators' assistance impacts measurements), which is a crucial aspect for a point-of-care device. However, the core measurement itself, once the breath sample is collected, is standalone.

7. The Type of Ground Truth Used

• Non-Clinical (Analytical) Studies:
  • Calibrated Reference Standard: For Accuracy, Precision, and Linearity, the ground truth was established using a chemiluminescence device calibrated against a NIST traceable NO tank measuring specific concentrations of nitric oxide mixed in simulated breath.
  • Controlled Input: For Limit of Detection and Interference (other gases), known, controlled concentrations of gases were presented to the device.
  • Self-reference (Baseline): For Interference (Exogenous Substances), each subject's own baseline Fenom Pro measurement before exposure served as the ground truth for evaluating the impact of the substances.
• Clinical Studies:
  • Comparative Assessment: For the Clinical Efficacy study, the "ground truth" for demonstrating the device's utility was established by comparison with established clinical assessments: FEV1 (spirometry) and ACQ/pACQ (asthma questionnaires).
  • Internal Consistency: For the Clinical Precision studies, the "ground truth" was essentially the device's own measurement output, and the studies focused on the consistency and variability of these measurements across different operators and occasions.

8. The Sample Size for the Training Set

The document does not explicitly describe a "training set" in the context of an machine learning model that would require separate training data. The device appears to be a physical sensor-based measurement system rather than a machine learning algorithm that learns from a dataset.

The listed studies refer to:

• Non-clinical testing: Performed on a limited number of devices (e.g., 2 devices for accuracy, 5 for precision) against controlled gas mixtures. This is instrument verification/validation, not AI model training.
• Clinical studies: These are validation studies on human subjects to demonstrate performance characteristics like precision and concordance with established clinical measures, after the device's design is largely finalized. They do not constitute a "training set" for an AI algorithm.

Therefore, the concept of a "training set sample size" as typically understood for AI/ML devices is not applicable here.

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

As explained in point 8, a "training set" for an AI/ML model is not applicable to this device description. The device's fundamental measurement principle relies on solid-state electrochemical sensor technology, calibrated using reference standards in a laboratory setting, rather than being "trained" on a large dataset of patient results.

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