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NIOX VERO® measures Nitric Oxide (NO) in human breath. Nitric Oxide is frequently increased in some airway inflammatory processes such as asthma. The fractional NO concentration in expired breath (FeNO), can be measured by NIOX VERO according to guidelines for NO measurement established by the American Thoracic Society.

Measurement of FeNO by NIOX VERO is a quantitative, non-invasive, simple and safe 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. NIOX VERO is suitable for children, 7- 17 years, and adults 18 years and older.

NIOX VERO 10 second test mode is for age 7 and up
NIOX VERO 6 second test mode is for ages 7-10 only who cannot successfully complete a 10 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 NIOX VERO is intended for prescription use and should only be used as directed in the NIOX VERO User Manual by trained healthcare professionals. NIOX VERO cannot be used with infants or by children under the age of 7 as measurement requires patient cooperation.

NIOX VERO should not be used in critical care, emergency care or in anesthesiology.

NIOX VERO is a portable system for the non-invasive, quantitative measurement of the fraction of exhaled nitric oxide (NO) in expired human breath (FeNO). NO levels increase during allergic airway inflammation. Measurement of changes in FeNO concentration is used in evaluating a patient's response to antiinflammatory therapy, as an adjunct to established clinical and laboratory assessments.

The NIOX VERO system is comprised of the NIOX VERO unit with AC adapter, a rechargeable battery, an electrochemical NO sensor, disposable patient filters, and an exchangeable handle containing an internal NO scrubber filter. The NIOX Panel is an optional PC application for operation of the NIOX VERO from a PC and access to electronic medical record systems. The device can connect to the PC via a standard USB cable or wirelessly via Bluetooth.

The patient empties their lungs, inhales deeply through the patient filter to total lung capacity and then slowly exhales for 10 seconds. A 6 second mode is available for children aged 7 – 10 who cannot perform a 10 second exhalation. In approximately one minute, the NO concentration is displayed in parts per billion (ppb).

The NIOX VERO unit includes a sampling and gas conditioning system and a man-machine interface (MMI). The instrument controls the inhaled sample appropriately via the electronics and software program. Filtering of inhaled air elimination from ambient NO levels. A built-in flow control keeps exhalation standardized at 50 ml/s so that it is standardized for all patients. The sample enters an electromechanical sensor and interacts with an electrolyte. A chemical reaction takes place where electrons are generated proportional to the number of NO molecules.

Results are processed using dedicated software. In order to verify the device's performance and reliability of measurements, there are built-in system control procedures and a Quality Control procedure to be performed on a daily basis.

The Circassia NIOX VERO device measures the fractional nitric oxide concentration in expired breath (FeNO) to evaluate an asthma patient's response to anti-inflammatory therapy. The 510(k) submission (K170983) is specifically for the activation of an existing 6-second measurement mode for children aged 7-10, in addition to the previously cleared 10-second mode.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the NIOX VERO are compared against the predicate device (NIOX VERO, K150233), and for the 6-second mode, the performance was found to be identical to these established criteria.

2. Sample Size and Data Provenance

• Test Set (Clinical Study AER-047):
  • Sample Size: 43 male and female subjects.
  • Data Provenance: Not explicitly stated, but the study was described as a "single-center" study. This suggests the data originated from one specific location. It was a "single-visit, point-of-care clinical validation study," indicating it was a prospective study.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

This information is not provided in the document. The study focuses on comparing the 6s mode against the 10s mode in children for their ability to successfully perform the test and maintain similar analytical performance characteristics, rather than expert-adjudicated ground truth for a diagnostic outcome.

4. Adjudication Method (Test Set)

This information is not provided. The clinical study described in the document is a validation study demonstrating the feasibility and performance equivalence of the 6s mode. It does not appear to involve a diagnostic outcome requiring expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC study was not conducted as this device measures a quantitative physiological biomarker (FeNO). The study performed was a clinical validation to demonstrate the equivalence of the 6s measurement mode. The device does not involve human readers interpreting images, so the concept of "human readers improve with AI vs without AI" is not applicable.

6. Standalone Performance (Algorithm Only)

Yes, a standalone (algorithm only) performance assessment was done. The performance bench testing (precision, accuracy, linearity) of the NIOX VERO in 6s mode was conducted independently and demonstrated to be within the specifications of the original NIOX VERO performance. This refers to the device's inherent ability to accurately measure FeNO, irrespective of human interaction beyond operating the device as intended.

7. Type of Ground Truth Used

• Clinical Study (AER-047): The "ground truth" for the clinical study was the successful completion and measurement of FeNO for the 6-second mode in children aged 7-10, and the comparison of these measurements to the established performance characteristics of the 10-second mode. It was about patient cooperation and the device's ability to consistently provide measurements in this cohort.
• Bench Testing: The ground truth for bench testing (precision, accuracy, linearity) was established by using certified calibration gas of known concentrations (5ppb, 25ppb, 75ppb, and 200ppb) as reference standards.

8. Sample Size for the Training Set

This information is not applicable and therefore not provided. The NIOX VERO is a measurement device, not an AI/ML-driven diagnostic algorithm that requires a training set in the conventional sense. The "6s measurement mode" was an existing functionality in the predicate device, not a newly developed algorithm requiring extensive training data.

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

This information is not applicable as there is no mention of a training set for an AI/ML algorithm. The device measures a physical parameter using electrochemical sensing.

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