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Vivatmo pro-S 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. Measurement of FeNO by Vivatmo pro-S 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.

Vivatmo pro-S is suitable for children, approximately 7-17 years, and adults 18 years and older.

Testing using the Vivatmo pro-S should only be done in a point-of-care healthcare setting under professional supervision. Vivatmo pro-S should not be used in critical care, emergency care or in anesthesiology.

The Vivatmo pro-S system is a automated, non-invasive (in-vitro diagnostic) medical device for professional environment for the quantitative measurement of FeNO (fractional exhaled Nitric Oxide) in human breath.

Measurement of changes in the fractional nitric oxide concentration in expired breath aids in evaluating a patient's response to anti-inflammatory therapy, as an adjunct to establish clinical and laboratory assessments of inflammatory processes such as asthma.

FeNO is recommended by the American Thoracic Society (ATS) in the diagnosis of eosinophilic airway inflammation and in determining the likelihood of responsiveness to anti-inflammatory pharmacological therapy in individuals with chronic respiratory symptoms possibly due to airway inflammation [ATS, 2011].

The Vivatmo pro-S device consists of the following main elements:

• Vivatmo pro-S handheld which holds the measuring module with electronics, display and a battery including software to drive the handheld.
• Vivatmo pro Oxycap/Vivatmo me Oxycap, which is a disposable mouthpiece to prepare the exhaled air for the measurement
• Vivatmo pro Level 0, a disposable mouthpiece to facilitate a measurement with 0 ppb FeNO for QC purpose (optional)

N/A

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Vivatmo 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 Vivatmo 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 measurements are to be used as an adjunct to established clinical assessments.

Vivatmo pro nitric oxide test is a portable, non-invasive device to measure fractional exhaled nitric oxide (FeNO) in human breath.

The provided text is a 510(k) summary for the Vivatmo pro device, a breath nitric oxide test system. It focuses on regulatory approval and substantial equivalence and does not contain detailed information about the acceptance criteria and the study that proves the device meets them. This type of information is typically found in the full 510(k) submission, which is not provided.

Therefore, I cannot extract the specific details requested in your prompt regarding acceptance criteria, study design, sample sizes, ground truth establishment, or multi-reader multi-case studies from the provided text. The document primarily confirms the FDA's determination of substantial equivalence.

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Fenom Pro 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 decreases in response to anti-inflammatory treatment. Fenom Pro measures fractional exhaled nitric oxide according to guidelines established by the American Thoracic Society.

Measurement of FENO by Fenom Pro is a non-invasive quantitative 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 measurements are to be used as an adjunct to established clinical assessments. Fenom Pro is suitable for adults and children 6 years and older.

Fenom Pro should be used 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 non-invasive point-of-care breath analyzer for the quantitative measurement of fractional exhaled nitric oxide (FENO) in expired human breath.

Fenom Pro is comprised of four major components. The main unit contains a touch screen interface for the user and houses the nitric oxide sensor and pneumatics needed to sample the patient's breath. The patient exhales into the Fenom Pro though a single use disposable mouthpiece which is attached to the handpiece. The handpiece is connected to the main unit via a breath tube.

For testing, the patient inhales to total lung capacity and then slowly exhales into the mouthpiece for 6 or 10 seconds, depending on the mode of operation. Approximately 28 seconds after a successful breath maneuver, the FENO concentration is displayed in parts per billion (ppb) on the device touch screen. The device has a daily quality control procedure to ensure consistent device performance.

The Fenom Pro device, a breath nitric oxide test system, was evaluated for performance against specified acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and data provenance:

   • The document states that "Clinical studies were performed to evaluate the clinical precision and clinical accuracy of the candidate device." However, specific sample sizes for these clinical studies are not provided in the summary.
   • The provenance of the data (e.g., country of origin, retrospective or prospective) is not explicitly mentioned.

3. Number of experts used to establish the ground truth for the test set and their qualifications: Not provided in the summary.

4. Adjudication method for the test set: Not provided in the summary.

5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: No MRMC study was mentioned. The device measures fractional exhaled nitric oxide (FENO) which is a quantitative measurement, not typically subject to subjective interpretation by multiple human readers in the same way as imaging studies. The indications for use state that FENO measurements are to be used as an adjunct to established clinical assessments, implying a standalone measurement rather than an AI-assisted human reading.

6. Standalone (algorithm only without human-in-the-loop performance) study: Yes, the device is described as measuring FENO quantitatively. The non-clinical and clinical studies performed (precision, accuracy, linearity, etc.) relate to the device's standalone performance in measuring FENO.

7. Type of ground truth used: For quantitative measurements like FENO, the ground truth would typically be established by highly accurate reference methods or calibration gases with known nitric oxide concentrations for non-clinical studies. For clinical studies, comparison to a gold standard FENO measurement device or clinical outcomes (e.g., response to anti-inflammatory treatment) would be used to establish clinical accuracy and precision. The summary implies that "studies were performed to evaluate performance with regards to the specificity (interference), precision, accuracy, linearity, effect of temperature and humidity, detection limit and stability" for non-clinical data, and "clinical precision and clinical accuracy" for clinical data. The exact nature of the "ground truth" (e.g., comparison to a specific reference method) for each of these studies is not detailed.

8. Sample size for the training set: Not applicable based on the provided information. This device is a measurement system and the information provided does not indicate the use of machine learning models requiring a specific "training set" in the common sense for AI/ML devices.

9. How the ground truth for the training set was established: Not applicable, as no training set for an AI/ML model is indicated.

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The NObreath® is a portable. non-invasive device for the measurement of Fractional Exhaled Nitric Oxide (FeNO) in human breath. The production of nitric oxide is often found to be increased in inflammatory conditions such as asthma. Measurement of FeNO by NObreath® 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 the therapeutic effect in patients with elevated FeNO levels.

The fractional NO concentration in expired breath (FeNO), can be measured by NObreath® according to guidelines for NO measurement established by the American Thoracic Society.

NObreath® is intended for children, 7- 17 years, and older. NObreath® 12 second test mode is for age 7 and up

NObreath® 10 second test mode is for ages 7-10 only who cannot successfully complete a 12 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 NObreath® cannot be used with infants or by children under the age of 7 as measurement requires patient cooperation.

NObreath® should not be used in critical care, emergency care or in anesthesiology.

NObreath® is a portable system for the non-invasive, quantitative measurement of the fraction of exhaled nitric oxide (NO) in expired human breath (FeNO). The NObreath® system is comprised of the main unit with AC adapter, a rechargeable battery, an electrochemical NO sensor, disposable patient mouthpiece with filter. The device can connect to the PC via a standard USB cable or wirelessly via Bluetooth.

For testing, the patient inhales deeply and slowly exhales for 10 or 12 seconds through the patient filter. In approximately 12 seconds the NO concentration is displayed in parts per billion (ppb). Results are processed using dedicated software. The device has built-in system control procedures and a calibration to be performed every 12 months.

Wireless Bluetooth Low Energy (BLE) is used as a means of communication between the monitor and FeNOchart™ software running on a PC. The FeNOchart™ software is a charting program that retrospectively collects data from the NObreath® monitor when it is not monitoring. It is not time critical, there are no alarms

The provided text describes the NObreath® device, a system for measuring Fractional Exhaled Nitric Oxide (FeNO). There is no acceptance criteria table or information related to an AI/ML-driven device in the provided text. The document is a 510(k) premarket notification summary for a medical device (NObreath®) which directly measures NO using an electrochemical sensor. Therefore, the questions related to AI/ML specific criteria (such as ground truth establishment for training, or MRMC studies) are not applicable to this device submission.

However, based on the information provided, here's a breakdown of the device's performance and supporting studies:

No acceptance criteria table for AI/ML device is provided, as this is not an AI/ML device.

The device performance data is presented as part of the clinical precision study.

Acceptance Criteria and Reported Device Performance (Table Based on Clinical Precision Study)

The "acceptance criteria" for a traditional medical device like NObreath® would typically be specified in terms of its analytical performance (accuracy, precision, measurement range, limit of detection) and clinical performance (how well it measures FeNO in a clinical setting). The document highlights the device's clinical precision.

Study Details:

1. Sample sizes used for the test set and data provenance:

   • Clinical Precision Study (Test Set):
     • Sample Size: 76 participants (24 pediatric, ages 7-17 years; 52 adults, 18+ years).
     • Data Provenance: Not explicitly stated, but given the sponsor (Bedfont Scientific Ltd) is based in England, the study was likely conducted in the UK or a similar regulatory environment. The study is retrospective in the sense that the data was collected for evaluation, but the measurements themselves are prospective in nature taken at the time of the study.
   • Clinical Efficacy Study (Longitudinal Study):
     • Sample Size: 186 patients (95 adults, 18+ years; 91 children, 7-17 years).
     • Data Provenance: Not explicitly stated, but likely from the same geographical region as the sponsor. This was a prospective longitudinal study with measurements at baseline and 2 weeks later.

2. Number of experts used to establish the ground truth for the test set and qualifications of those experts (e.g. radiologist with 10 years of experience):

   • This is not an AI/ML device, so "ground truth" for image interpretation by experts is not applicable in the typical sense.
   • For the clinical precision study, the device's own measurements are being evaluated for their agreement. "Ground truth" here is less about expert interpretation and more about the inherent biological variation and device measurement variability. The study involved the assistance of three healthcare professionals (HCPs) for collecting the six FeNO evaluations per participant, suggesting their role in operating the device and ensuring proper technique rather than establishing a diagnostic ground truth. Their qualifications are not specified beyond "HCPs."
   • For the clinical efficacy study, the "ground truth" for the effectiveness of a therapeutic agent (corticosteroids) is established by the observed fall in FeNO measurements by the device itself, alongside changes in established clinical and laboratory assessments (ACQ score, FEV1). These are objective clinical measures rather than expert consensus on a subjective interpretation.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable as this is not an AI/ML device requiring adjudication of interpretations. The clinical precision study aimed to capture user bias but not through an adjudication process of diagnostic outputs. Each participant had six measurements taken by HCPs, and the data was analyzed for within-subject precision.

4. 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:

   • No, this is not an AI-assisted device, so an MRMC study comparing human readers with and without AI assistance was not performed.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • This is a standalone diagnostic device. The performance data presented (precision and efficacy) are "standalone" in the sense that they represent the device's ability to measure FeNO. Human interaction is required for operation (patient breathing into the device, HCPs assisting), but there isn't an algorithm that operates independently to provide a diagnostic output without direct human interaction in the measurement process.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For Clinical Precision: The "ground truth" is typically the true underlying FeNO concentration, which is approximated by repeated measurements from the device itself. The study design acknowledges variability and aims to quantify it. It's more about characterizing instrument performance than a singular "truth" established by an external reference.
   • For Clinical Efficacy: The "ground truth" for demonstrating efficacy of FeNO measurement in monitoring therapy response is the physiological change in FeNO levels and correlation with established clinical outcomes data (ACQ, FEV1) following therapeutic intervention. This is an outcomes-based approach in a clinical trial context.

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device that requires a training set in the sense of machine learning. The device's electrochemical sensor and internal algorithms are based on established physical and chemical principles and traditional engineering calibration, not data-driven learning from a "training set."

8. How the ground truth for the training set was established:

   • Not applicable. As above, there is no AI/ML training set. The device would be calibrated using known gas concentrations, with precision and accuracy validated through bench testing using reference standards and then clinically validated.

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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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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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NIOX VERO® 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 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, 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. 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 approximately 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 exhale for 10 seconds. 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 provided text describes a Special 510(k) summary for the NIOX® VERO Airway Inflammation Monitor (K150233). This submission is specifically for the activation of existing Bluetooth technology on the predicate device (K133898). Therefore, the performance testing focuses on wireless functionality and its impact, not on the core diagnostic capabilities of measuring FeNO. The document states that the core performance characteristics (analytical limits, precision, accuracy, measurement range, linearity) are identical to the predicate device.

Here's an analysis based on the provided text, addressing your points:

1. A table of acceptance criteria and the reported device performance

Since this 510(k) is for activating Bluetooth, the acceptance criteria and performance for the core function (FeNO measurement) are referenced as being identical to the predicate device (K133898). The key performance criteria for the Bluetooth activation itself relate to wireless coexistence and safety.

2. Sample size used for the test set and the data provenance

The document does not specify a separate "test set" sample size for the Bluetooth activation. It refers to
"Verification and validation testing was previously performed for Bluetooth functionality prior to FDA clearance."
and "FCC Part 15B testing was repeated with the Bluetooth module active in the NIOX VERO."

The data provenance for the wireless testing is implied to be from the manufacturer's internal testing, conducted previously and then repeated for the US market activation. The country of origin for the internal testing is not explicitly stated, but the manufacturer is based in Sweden. Given the nature of Bluetooth standards and FCC regulations, such testing generally follows international or country-specific standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable for this type of submission. The testing described for Bluetooth activation does not involve expert-established ground truth in the way a clinical diagnostic study would. The ground truth for electrical and wireless performance is defined by industry standards and regulatory requirements (e.g., FCC regulations).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable for this type of submission. Adjudication methods are typically used in studies where clinical interpretations or diagnoses are being evaluated by multiple experts.

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

Not applicable. This device is a diagnostic tool for measuring FeNO, and the submission concerns the activation of wireless connectivity. It is not an AI-assisted diagnostic tool involving human reader interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device's core function (FeNO measurement) is standalone in the sense that it provides a quantitative measurement. The submission for Bluetooth activation itself is a re-validation of wireless functionality, which is a standalone technical performance. The text states:

"Verification and validation were previously performed to demonstrate that the USB cable communications functions are equivalent to the Bluetooth wireless communication operation."

This indicates that equivalence between wired and wireless communication, both standalone technical functions, was established.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For the core FeNO measurement specified as "identical to predicate," the ground truth for analytical performance (accuracy, precision, linearity) typically relies on reference methods or calibrated gas standards. This document doesn't detail how the predicate's ground truth was established, but it would not be based on expert consensus, pathology, or outcomes data.

For the Bluetooth activation, the "ground truth" for wireless coexistence and safety is compliance with regulatory standards and guidelines (e.g., FCC Part 15B, FDA Radio Frequency Wireless Technology in Medical Devices guidance).

8. The sample size for the training set

Not applicable for this type of device and submission. This is not a machine learning or AI-based device that would require training sets.

9. How the ground truth for the training set was established

Not applicable, as no training set is described or relevant for this submission.

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NIOX VERO® 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 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, 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. 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 approximately 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 anti-inflammatory 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 patient empties their lungs, inhales deeply through the patient filter to total lung capacity and then slowly exhale for 10 seconds. 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.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions "A comparison study was performed between the NIOX MINO and the NIOX VERO which demonstrate substantial equivalence in a clinical setting." However, the specific sample size for this clinical comparison study and the provenance (e.g., country of origin, retrospective or prospective) of the data are not provided in the supplied text.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the supplied text. The device measures Fractional exhaled Nitric Oxide (FeNO), and the ground truth for such measurements would typically be based on the device's analytical precision and accuracy using certified gas samples, rather than expert consensus on medical images or clinical judgment.

4. Adjudication Method for the Test Set

This information is not applicable to the type of device and study described and is not provided in the supplied text. Adjudication methods like 2+1 or 3+1 are typically used in studies where multiple human readers interpret data (e.g., images) and their interpretations need to be reconciled to establish a ground truth. For a device measuring a quantitative physiological parameter like FeNO, the "ground truth" is established by the accuracy and precision of the measurement itself against known standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. without AI Assistance

This information is not applicable and not provided in the supplied text. The NIOX VERO is a standalone medical device that measures FeNO. It is not an AI-assisted diagnostic tool that would be used by human readers to interpret complex data. Therefore, an MRMC study and the concept of human readers improving with AI assistance are not relevant to this device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the performance characteristics (Analytical limits, Precision, Accuracy, Measurement Range, Linearity) listed in the table under "Reported Device Performance (NIOX VERO)" are indicative of standalone performance as they describe the intrinsic measurement capabilities of the device itself. These tests were conducted using "Nitric Oxide gas samples at certified concentrations," which evaluates the device's ability to accurately measure known quantities of NO independently.

7. The Type of Ground Truth Used

The ground truth for the performance testing was established using Nitric Oxide gas samples at certified concentrations. This allows for the direct comparison of the device's readings against a known, accurate reference.

8. The Sample Size for the Training Set

This information is not provided in the supplied text. The document describes a "510(k) premarket notification" for an established medical device type (FeNO measurement systems). While there may be internal development and calibration (training) processes, the FDA submission focuses on showing substantial equivalence through specific performance criteria rather than detailing training set sizes for machine learning models.

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

This information is not explicitly provided in the supplied text. Similar to the test set, it is highly probable that the ground truth for any internal training or calibration of the device would also involve the use of Nitric Oxide gas samples at certified concentrations to ensure accurate and precise measurements. The document mentions "The sensor stabilization process has been modified. Instead of maintaining the sensor at a constant temperature, there is a compensation algorithm for temperature and humidity correction to the measurement result." This suggests calibration and potentially a training phase where data is collected and used to develop or refine such compensation algorithms, likely against known NO concentrations under varying environmental conditions.

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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 is a small, hand-held, portable system for the non-invasive, online, quantitative measurement of fractional nitric oxide (NO) concentration in expired human breath (FeNO) measured in parts per billion (ppb). The device is intended for routine clinical use and laboratory assessments of the patient's condition.

Measurement of changes in 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. 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 NO concentration in ppb. In order to verify the device's performance and reliability of measurements, there are builtin system control procedures and a special designed External Quality Test Program to be performed on a daily basis.

NIOX Panel is an optional software program accessory which provides an additional display for operating the NIOX MINO Airway Inflammation Monitor by allowing the user to operate the instrument from their personal computer (PC). Interaction with the NIOX Panel is performed with common human interface devices such as keyboards, mice, etc. A USB interface is used for communication with connected NIOX MINO instruments. Instrument supervision and measurement analysis is still performed by the NIOX MINO instrument, however. The NIOX Panel merely serves as an additional interface to the instrument thus, complementing the instrument's LCD screen.

Here's a breakdown of the acceptance criteria and study information for the NIOX® Panel, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on the NIOX® Panel as a software accessory that offers an alternative interface for the existing NIOX MINO® device. It asserts that the fundamental technological characteristics and measurement performance of the core device (NIOX MINO®) remain unchanged. Therefore, the "acceptance criteria" for the NIOX® Panel are implicitly tied to demonstrating that this new interface does not degrade the already established performance of the NIOX MINO®.

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

The document does not describe a clinical study or a specific test set with a sample size for the NIOX® Panel. This submission is a Special 510(k), which is typically used for modifications to a legally marketed device that do not significantly alter its fundamental safety or effectiveness. The core argument is that the NIOX® Panel is only an alternative interface and does not change the underlying measuring capabilities of the NIOX MINO®. Therefore, a new clinical performance study with a test set is not deemed necessary and is not reported.

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

Not applicable. As noted above, a new clinical performance study with a test set requiring expert-established ground truth is not described in this Special 510(k) submission.

4. Adjudication Method for the Test Set

Not applicable. No new test set requiring adjudication is described.

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

Not applicable. This device is not an AI-assisted diagnostic tool that would involve human readers interpreting cases. The NIOX® Panel is a display accessory for a quantitative breath test device.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

This pertains to the NIOX MINO® in general, rather than specifically the NIOX® Panel. The NIOX MINO® is a standalone device that provides a quantitative measurement (FeNO in ppb). The NIOX® Panel acts solely as an additional display interface; it doesn't represent a separate algorithm or standalone performance independent of the NIOX MINO®'s existing measurement capabilities. The original predicate device (NIOX MINO® K101034) would have demonstrated its standalone performance.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the original NIOX MINO® device, the ground truth for establishing its performance (precision, accuracy, linearity, etc.) would likely have involved:

• Reference standards/calibrators: Using gases with known, certified concentrations of nitric oxide.
• Comparison to established laboratory methods: Correlating FeNO measurements with gold-standard laboratory techniques for NO measurement.
• Clinical correlation: Demonstrating the device's ability to measure changes in FeNO in asthma patients responding to anti-inflammatory therapy, likely against clinical outcomes and other diagnostic assessments.

However, for the NIOX® Panel specifically, no new ground truth determination is mentioned beyond ensuring the interface correctly displays the data generated by the NIOX MINO® without alteration or error.

8. The Sample Size for the Training Set

Not applicable. This device does not involve machine learning or AI models with training sets.

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

Not applicable. This device does not involve machine learning or AI models with training sets.

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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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