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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.

Device Description

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.

AI/ML Overview

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:

Study Category	Acceptance Criteria	Reported Device Performance	Pass/Fail (based on stated performance)
Accuracy	For 15 ppb: +/- 5 ppb	Across 5 environmental conditions for 2 devices and 5 replicates each, all results for 15 ppb target concentration were within +/- 5 ppb. (e.g., Ambient T/RH: GP18 had upper 95% error limit of 0.17ppb and lower of -1.97ppb; GP35 had upper 0.44ppb and lower -3.84ppb).	Pass
	For 75 ppb & 200 ppb: +/- 10%	Across 5 environmental conditions for 2 devices and 5 replicates each, all results for 75 ppb and 200 ppb target concentrations were within +/- 10%. (e.g., Ambient T/RH: GP18 had upper 1.83% and lower -2.12% for 75ppb; High T/Low RH: GP35 had upper -1.63% and lower -3.38% for 200ppb).	Pass
Precision (Repeatability)	Not explicitly stated as a pass/fail criterion in the table, but reported as SD (ppb) and %CV.	For 10 ppb: SDs ranged from 1.1 to 1.9 ppb.
For 25 ppb: SDs ranged from 1.2 to 2.3 ppb.
For 75 ppb: %CVs ranged from 3.2% to 7.1%.
For 200 ppb: %CVs ranged from 3.0% to 7.3%.	N/A (Data Reported)
Precision (Within-Device)	Not explicitly stated as a pass/fail criterion in the table, but reported as SD (ppb) and %CV.	For 10 ppb: SDs ranged from 1.2 to 2.3 ppb.
For 25 ppb: SDs ranged from 1.2 to 3.3 ppb.
For 75 ppb: %CVs ranged from 4.3% to 7.5%.
For 200 ppb: %CVs ranged from 3.4% to 8.5%.	N/A (Data Reported)
Linearity	Slope between 0.95 and 1.05 and R (correlation coefficient) presumably close to 1.0.	Device GammaPrime42: Slope 1.03, Intercept 2.32, R 0.999.
Device GammaPrime49: Slope 1.02, Intercept 0.231, R 0.999.
Combined: Slope 1.02, Intercept 1.27, R 0.998.	Pass
Limit of Detection (LoD)	0.9873 for all HCP pairs), and all bias analyses demonstrated very high quantitative agreement.	Pass (Implied)
Clinical Precision (Within-subject Variability)	Less than 5 ppb by mean standard deviation for FeNO values below 50 ppb.
%CVs for FeNO values greater than 50 ppb were maintained at less than 10%, "unless sample size was small."	Across both clinical precision studies and all age groups:

For FeNO = 50ppb: Mean CVs were generally less than 10%. Exceptions also occurred with small N (e.g., 5-17 Visit 1 75-

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