(141 days)
NIOX MINO measures Nitric Oxide (NO) in human breath. Nitric Oxide is frequently increased in some inflammatory processes such as asthma. The fractional NO concentration in expired breath (FENO), can be measured by NIOX MINO according to guidelines for NO measurement established by the American Thoracic Society.
Measurement of FENO by NIOX MINO 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 MINO is suitable for children, approximately 7 - 17 years, and adults 18 years and older.
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. NIOX MINO should only be used as directed in the User Manual and by physicians, nurses, respiratory therapists and laboratory technicians. NIOX MINO cannot be used with infants or by children approximately under the age of 7, as measurement requires patient cooperation. NIOX MINO should not be used in critical care, emergency care or in anaesthesiology.
NIOX MINO is a small, hand-held, portable system for the non-invasive, online, quantitative measurement of the fractional nitric oxide (NO) concentration in expired human breath (FENO) measured in parts per billion levels (ppb). The device is intended for routine clinical use and is suitable for point of care settings.
Measurement of changes in the FENO concentration is used in evaluating an asthma patient's response to anti-inflammatory therapy, as an adjunct to established clinical and laboratory assessments of asthma. All results are to be interpreted in conjunction with other clinical and laboratory assessments of the patient's condition.
The NIOX MINO unit includes a sampling and gas conditioning system and a man-machine interface (MMI). The user is guided by the built-in touch-screen display through the breathing maneuver by use of the interactive MMI. The valves and pumps of the instrument are automatically controlled to handle the inhaled sample appropriately via the instrument electronics and software program. Filtering of inhaled air eliminates contamination from ambient NO levels. A built-in flow control keeps exhalation standardized at 50 ml/s.
Results are processed using dedicated software and are expressed as the Nitric Oxide concentration in parts per billion (ppb).
To be able to verify the performance of the device and reliability of measurements, there are built-in system control procedures and a special designed External Quality Control Test Program, to be performed on a daily basis.
Here's a breakdown of the acceptance criteria and the study information for the Aerocrine NIOX MINO device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Parameter | Specification Tolerance Limits and Definition | Reported Device Performance (Implied) |
|---|---|---|
| Linearity | Squared correlation coefficient $r^2 > 0.998$, slope 0.95 – 1.05, intercept ±3 ppb. Determination based on the regression analysis using standard gas reference samples at seven different concentration levels covering the operating measurement range. | Within Technical Specification (K072816) |
| Lowest Detection Limit | 5 ppb. Determination by analyzing gas concentrations around and below the detection limit. | 5 ppb (lowest detectable level) |
| Precision | 50 ppb, from certified gas concentration of Nitric Oxide reference standard. | Within Technical Specification (K072816) |
| Method comparison | 50 ppb. Expressed as the difference between a NIOX MINO FENO value and the corresponding FENO value measured with NIOX instrument from Aerocrine. | Within Technical Specification (K072816) |
Note: The document explicitly states, "The results from performed Validation, Verification and Testing conclude that the performance of the modified version of NIOX MINO is within the Technical Specification, initially established for NIOX MINO in application K072816." This implies that the device met these criteria, but specific numerical results for the modified device are not provided beyond the stated specifications themselves.
2. Sample Size Used for the Test Set and Data Provenance
The document mentions a "clinical study, named AER-039," which was used for "Clinical validation and method comparison." However, it does not specify the sample size for this study or any other test set.
The study is described as a "randomized, single-centre study." No country of origin is explicitly stated, but the company is based in Sweden with a US address, suggesting the clinical study could have been conducted in either region, or elsewhere. It is a prospective study as it's a clinical validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The study AER-039 focuses on agreement between two devices rather than establishing ground truth against "expert" assessment for individual patient conditions.
4. Adjudication Method for the Test Set
This information is not provided in the document. The study AER-039 aims to determine agreement between two devices, not to adjudicate conflicting expert opinions on a diagnosis or condition.
5. 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
This device, the NIOX MINO, is an airway inflammation monitor that measures fractional nitric oxide (FENO) concentration in expired breath. It is a standalone measurement device and does not involve "human readers" or "AI assistance" in interpreting images or other data. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers is not applicable to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself is a standalone measurement system. The performance criteria (linearity, precision, accuracy, detection limit) are evaluated for the device without human intervention in the measurement process. The "Method comparison" study (AER-039) compares the standalone performance of the NIOX MINO -09 device against the NIOX Flex Nitric Oxide Monitoring system.
7. The Type of Ground Truth Used
For the laboratory performance parameters (Linearity, Lowest Detection Limit, Precision, Accuracy), the ground truth was based on certified gas reference samples of NO in N2 of known concentrations.
For the "Method comparison" (AER-039), the "ground truth" was effectively the measurement from a predicate device, the NIOX Flex Nitric Oxide Monitoring system. The study aimed to determine the agreement between the two devices.
8. The Sample Size for the Training Set
This information is not applicable/not provided for this device. The NIOX MINO is not an AI/ML device that requires a "training set" in the conventional sense. Its functionality is based on electrochemical detection and established physical/chemical principles, not learned from data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" in the context of an AI/ML algorithm. The device's calibration and verification are done using certified reference standards (as described in point 7).
§ 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.