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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

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).

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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 NIOX MINO User Manual and the NIOX MINO Quality Control Test User Manual, by trained 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® Airway Inflammation Monitor is a hand held device intended to measure fractional exhaled nitric oxide in human breath in ppb levels (parts per billion), complying with 21 CFR 862.3080.

Here's an analysis of the acceptance criteria and study information for the NIOX MINO® device based on the provided text, structured according to your requested points:

Acceptance Criteria and Device Performance for NIOX MINO®

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: The document does not explicitly state the specific sample size (number of patients or measurements) used for the clinical or non-clinical test sets. It mentions "Multi-center clinical studies" and "Extensive performance testing," but no numerical figures are provided for the number of participants or cases.
• Data Provenance: The manufacturer, Aerocrine AB, is located in Sweden. The clinical studies were described as "Multi-center clinical studies," suggesting locations potentially beyond Sweden, but specific countries are not mentioned. The studies were designed to "validate the intended use and verify substantial equivalence," which implies a prospective data collection for evaluation of the new device.

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

The document does not provide information on the number of experts used or their specific qualifications for establishing ground truth within the context of the clinical studies. The device measures "fractional exhaled nitric oxide in human breath," and the "guidelines for NO measurement established by the American Thoracic Society" are mentioned. Therefore, the ground truth for NO measurements would likely be based on these established protocols, rather than expert consensus on interpreting an image or complex diagnostic output.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for the test set. Given the nature of the device measuring a physiological parameter (FENO), the "ground truth" would generally be derived from direct measurements according to established protocols, not from expert interpretation requiring adjudication.

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 question is not applicable to this device. The NIOX MINO® is an airway inflammation monitor that measures a biomarker (FENO) directly from breath. It is not an AI-based diagnostic imaging or interpretive aid that would involve "human readers" or "AI assistance" in the typical sense of medical imaging MRMC studies. The device provides a quantitative measurement, not an interpretation that human readers would perform.

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

This question is not applicable in the context of an AI algorithm. The NIOX MINO® is a standalone device in the sense that it performs the measurement independently. However, it's not an "algorithm only" device; it's a physical monitoring system. The device's performance is inherently its standalone performance, as it takes a measurement and displays a value. The clinical studies evaluated the performance of this device in its intended use.

7. The Type of Ground Truth Used

The ground truth for the device's measurements is the actual concentration of nitric oxide (NO) in human breath, as measured by a highly accurate reference method or standard. The document mentions:

• "certified gas concentration of Nitric Oxide reference standard" for analytical precision and accuracy.
• "corresponding FENO value measured with NIOX instrument from Aerocrine" for method comparison, implying the predicate device serves as a reference.
• Implicitly, the "guidelines for NO measurement established by the American Thoracic Society" define the correct methodology for obtaining FENO values in a clinical setting.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of an AI/machine learning model. The NIOX MINO® is a medical device that measures a physiological marker, not a software algorithm that is trained on a dataset. Therefore, the concept of a training set as understood in AI development is not directly applicable here. The device's internal calibration and operating parameters would be established during its design and manufacturing.

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

As explained in point 8, the concept of a "training set" for an AI model is not applicable. The device's accuracy and precision (its "ground truth" performance) are established through testing against certified gas standards and comparison with a predicate device, as detailed in Table 5-1 and the "Non-clinical studies performed" section.

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