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510(k) Data Aggregation
(24 days)
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.
| Acceptance Criteria (from Predicate/Identical) | Reported Device Performance (NIOX VERO) |
|---|---|
| Analytical limits at low levels (limit of detection): 5 ppb | Identical to predicate: 5 ppb |
| Precision (for values < 30 ppb): < 3 ppb of measured value | Identical to predicate: < 3 ppb of measured value |
| Precision (for values ≥ 30 ppb): < 10% of measured value | Identical to predicate: < 10% of measured value |
| Accuracy: +/- 5 ppb or max 10% | Identical to predicate: +/- 5 ppb or max 10% |
| Measurement Range: 5 - 300 ppb | Identical to predicate: 5 - 300 ppb |
| Linearity, reportable range: Squared correlation coefficient r² ≥ 0.998, slope 0.95 - 1.05, intercept ±3ppb | Identical to predicate: Squared correlation coefficient r² ≥ 0.998, slope 0.95 - 1.05, intercept ±3ppb |
| Wireless Coexistence/Safety: No risks from wireless interference in the clinical setting (as per FDA Radio Frequency Wireless Technology in Medical Devices guidance) | Wireless coexistence testing performed; demonstrated no additional risks from wireless interference. FCC Part 15B testing repeated with Bluetooth active. |
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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(321 days)
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
| Performance Characteristic | Acceptance Criteria (NIOX MINO predicate) | Reported Device Performance (NIOX VERO) |
|---|---|---|
| Analytical limits (LOD) | 5 ppb | 5 ppb |
| Precision | < 3 ppb for values < 30 ppb; < 10% for values ≥ 30 ppb | < 3 ppb for values < 30 ppb; < 10% for values ≥ 30 ppb |
| Accuracy | +/- 5 ppb or max 10% | +/- 5 ppb or max 10% |
| Measurement Range | 5 - 300 ppb | 5 - 300 ppb |
| Linearity | Squared correlation coefficient r² ≥ 0.998, slope 0.95 - 1.05, intercept ±3ppb | Squared correlation coefficient r² ≥ 0.998, slope 0.95 - 1.05, intercept ±3ppb |
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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(27 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 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®.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Comments |
|---|---|---|---|
| Technological Characteristics | Analytical principle of electrochemical detection remains the same. | The analytical principle remains the same. | The core measurement technology of the NIOX MINO® is unchanged. |
| NO sensor design and signal processing remains the same. | The NO sensor design and signal processing remain the same. | No changes to the sensor or how it converts signals. | |
| Principle for sample collection and handling inside the instrument remains the same. | The principle for sample collection and handling remains the same. | The physical interaction with the patient and sample preparation within the device are unaffected. | |
| Format of the measurement result remains unchanged. | The format of the measurement result remains unchanged. | The output (e.g., ppb) is the same. | |
| Measurement Performance | Precision specifications remain the same. | Specifications are the same. | Implicitly, the NIOX Panel does not negatively impact precision. |
| Linearity specifications remain the same. | Specifications are the same. | Implicitly, the NIOX Panel does not negatively impact linearity. | |
| Accuracy specifications remain the same. | Specifications are the same. | Implicitly, the NIOX Panel does not negatively impact accuracy. | |
| Detection limit specifications remain the same. | Specifications are the same. | Implicitly, the NIOX Panel does not negatively impact the detection limit. | |
| Intended Use | Intended Use remains unchanged. | The Intended Use for NIOX MINO when used with NIOX Panel remains unchanged. | The clinical purpose and patient population are not altered by the new display option. |
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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(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 | < 3 ppb of measured value < 30 ppb, < 10 % of measured value $\geq$ 30 ppb. Expressed as one standard deviation for replicate measurements with the same instrument, using a certified gas concentration of Nitric Oxide reference standard. | Within Technical Specification (K072816) |
| Accuracy | ± 5 ppb or max 10 %. Expressed as the upper 95% confidence limit, based on absolute differences for concentrations ≤ 50 ppb and relative differences for concentrations > 50 ppb, from certified gas concentration of Nitric Oxide reference standard. | Within Technical Specification (K072816) |
| Method comparison | < 10 ppb for values ≤ 50 ppb, < 20 % for values > 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).
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(153 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 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
| Characteristic | Acceptance Criteria (from text) | Reported Device Performance (NIOX MINO®) |
|---|---|---|
| Linearity | N/A (Predicate Device NIOX®: Integral linearity < 2.5 ppb) | Squared correlation coefficient $r^2 ≥ 0.998$ |
| Precision | N/A (Predicate Device NIOX®: Analytical precision < 2.5 ppb of measured value < 50 ppb; < 5 % of measured value > 50 ppb; Clinical precision < 2.5 ppb of measured value < 50 ppb) | Analytical precision: < 3 ppb of measured value < 30 ppb; < 10 % of measured value ≥ 30 ppb (Expressed as one standard deviation for replicate measurements with the same instrument, using a certified gas concentration of Nitric Oxide reference standard.) Clinical precision: < 3 ppb of measured value < 30 ppb (Clinical precision for values ≥ 30 ppb has not been established.) |
| Accuracy | N/A (Predicate Device NIOX®: Analytical accuracy ± 2.5 ppb of measured value < 50 ppb; ± 5% of measured value > 50 ppb) | Analytical Accuracy: ± 5 ppb or max 15% (Based on mean of absolute differences from certified gas concentration of Nitric Oxide reference standard. (95% CI)) |
| Method | N/A (Predicate Device NIOX®: No direct comparable criterion specified for method comparison with a different device) | ± 5 ppb for values < 50 ppb (Expressed as the difference, using one standard deviation, between a NIOX MINO FENO value and the corresponding FENO value measured with NIOX instrument from Aerocrine.) |
| Equivalence | The overall acceptance criteria are implicitly tied to demonstrating "substantial equivalence" to the predicate device (NIOX® Nitric Oxide Monitoring System, K021133) in terms of intended use and performance characteristics, as stated in the "Device Description" section. This includes laboratory and clinical tests. | "The performance characteristics for NIOX MINO Airway Inflammation Monitor and NIOX Nitric Oxide Monitoring System are substantially equivalent as shown in laboratory and clinical tests." The results from performance testing (linearity, precision, accuracy) "support substantial equivalence between NIOX MINO and NIOX." |
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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