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The INOmax® DS delivery system delivers INOmax® (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. It uses a specially designed injector module, which enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with most ventilators.

The INOmax® DS provides continuous integrated monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system.

The INOmax® DS incorporates a battery that provides up to 6 hours of uninterrupted NO delivery in the absence of an external power source.

The INOmax® DS includes a backup NO delivery capability that provides a fixed flow of 250 mL/min of NO which along with user supplied 10 L/min of oxygen provides 20 ppm in the gas flow to a patients breathing circuit. It may also use the INOblender® for backup.

The target patient population is controlled by the drug labeling for INOmax® and is currently neonates. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and secondary targeted clinical setting is the transport of neonates.

The INOmax DSIR® uses a "dual-channel" design to ensure the safe delivery of INOmax®. The first channel has the delivery CPU, the flow controller and the injector module to ensure the accurate delivery of NO. The second channel is the monitoring system, which includes a separate monitor CPU, the gas cells (NO, NO2, and O2 cells) and the user interface including the display and alarms. The dual-channel approach to delivery and monitoring permits INOmax® delivery independent of monitoring but also allows the monitoring system to shutdown INOmax delivery if it detects a fault in the delivery system such that the NO concentration could become greater than 100 ppm. The delivery system can also shut down delivery if it detects certain serious problems with the monitoring system.

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes software and labeling modifications to the INOmax DSIR, focusing on alarm thresholds and compatibility with new respiratory care devices. The acceptance criteria are implicitly met by successful verification testing. The performance is described by how the modified alarms function and successful compatibility testing.

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

• Test Set Sample Size: The document does not specify a numerical sample size for the "test set" in terms of cases or patients. Instead, it refers to testing conducted with:
  • Five INOmax DSIR® settings: 0 (baseline), 5, 20, 40, and 80 ppm, "for each setting and mode of ventilation." This implies a systematic study across different operational parameters.
  • Three new respiratory care devices: Fisher & Paykal Infant Circuit Nasal Cannula (K020332), Fisher and Paykal Optiflow Breathing Circuit (K983112), and A-Plus Medical Babi Plus Bubble CPAP (K110471).
• Data Provenance: The testing described is non-clinical and conducted by the manufacturer, INO Therapeutics/Ikaria. The data is thus prospective internal testing data. The country of origin is not explicitly stated for the testing, but the company is based in Madison, Wisconsin, USA.

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 testing described is non-clinical performance and compatibility testing of a medical device, not a diagnostic algorithm that relies on expert interpretation for ground truth establishment.

4. Adjudication Method for the Test Set:

This information is not provided and is not applicable to the type of non-clinical device testing described. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple experts evaluate cases and a consensus or tie-breaking mechanism is needed for ground truth.

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:

No, an MRMC comparative effectiveness study was not done. This document describes the premarket notification for a medical device (nitric oxide delivery system), not an AI-based diagnostic tool or system designed to assist human readers.

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

The device itself is a standalone system for delivering nitric oxide and monitoring gases. The document describes "software verification" and "performance testing" of the device, which inherently represents its standalone (without human intervention once settings are applied) functionality for its intended purpose. The modifications discussed pertain to the internal logic and alarm triggers of this standalone system.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance is established by:

• Technical Specifications/Requirements: The device is tested against its established system-level requirements and specifications, as well as recognized consensus standards (e.g., IEC 60601 series).
• Physical Measurements: For performance aspects like NO delivery accuracy, measured values from the INOmax DSIR® are recorded and compared against known input settings.
• Functional Verification: For alarms and compatibility, the "ground truth" is whether the alarm triggers as expected under specified conditions or if the integration with other devices functions without issues and meets predefined operational criteria (e.g., no detrimental O2 dilution, no adverse effect on respiratory care device).

8. The Sample Size for the Training Set:

The concept of a "training set" is not applicable to this document. The INOmax DSIR® is a hardware device with embedded software; it does not utilize machine learning or AI that requires a training set in the conventional sense. The "training" for the software's development would implicitly come from the extensive design, development, and iterative testing processes, but not from a distinct, labeled "training set" of data.

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

As there is no "training set" in the context of machine learning, the question of how its ground truth was established is not applicable. The "ground truth" for the device's design and functionality is derived from engineering specifications, medical device standards, risk analysis, and clinical requirements for patient safety and efficacy.

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The INOmax DS delivery system delivers INOmax® (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. It uses a specially designed injector module, which enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with most ventilators.

The INOmax DS provides continuous integrated monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system.

The INOmax DS incorporates a battery that provides up to 6 hours of uninterrupted NO delivery in the absence of an external power source.

The INOmax DS includes a backup NO delivery capability that provides a fixed flow of 250 mL/min of NO which along with user supplied 10 L/min of oxygen provides 20 ppm in the gas flow to a patients breathing circuit. It may also use the INOblender for backup.

The target patient population is controlled by the drug labeling for INOmax and is currently neonates. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and secondary targeted clinical setting is the transport of neonates.

The INOmax DSIR uses a "dual-channel" design to ensure the safe delivery of INOmax. The first channel has the delivery CPU, the flow controller and the injector module to ensure the accurate delivery of NO. The second channel is the monitoring system, which includes a separate monitor CPU, the gas cells (NO, NO2, and O2 cells) and the user interface including the display and alarms. The dual-channel approach to delivery and monitoring permits INOmax delivery independent of monitoring but also allows the monitoring system to shutdown INOmax delivery if it detects a fault in the delivery system such that the NO concentration could become greater than 100 ppm.

The provided document describes the INOmax DSIR, a nitric oxide delivery system, and its compatibility with additional respiratory care devices. The submission focuses on non-clinical testing to demonstrate substantial equivalence, rather than a study involving clinical outcomes or diagnostic accuracy. Therefore, information related to observer performance studies (e.g., MRMC studies, standalone performance), ground truth establishment for diagnostic tasks, expert qualifications, and adjudication methods is not applicable to this submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document describes non-clinical testing involving the INOmax DSIR and three specific respiratory care devices:

• (K102775) Hamilton C2
• (K070513) Hamilton G5
• (K100011) Fisher & Paykel Healthcare Bubble CPAP System

The testing involved using six INOmax DSIR settings: [0 (baseline), 1, 5, 20, 40] ppm (the sixth value is cut off but implied to be another concentration in ppm). The document states, "The three respiratory care devices were set up and calibrated according to the manufacturer's recommendations, and tested using the settings established for each respiratory care device test." This suggests a systematic testing approach across different settings for each device. However, a specific numerical "sample size" in terms of number of patient cases or repeated measurements for statistical analysis is not detailed in the provided text.

The data provenance is prospective non-clinical testing conducted by INO Therapeutics/Ikaria, likely at their facilities, to evaluate compatibility and performance. There is no indication of country of origin of patient data as no patient data was used.

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

Not applicable. This was a non-clinical device compatibility and performance study, not a diagnostic accuracy study requiring expert-established ground truth. The "ground truth" was the expected performance according to published specifications and manufacturer recommendations for the devices.

4. Adjudication Method for the Test Set

Not applicable. This was a non-clinical device compatibility and performance study, not a diagnostic accuracy study requiring adjudication of expert interpretations.

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. No MRMC study was conducted, as this submission concerns the hardware and software performance of a nitric oxide delivery system and its compatibility with other respiratory devices, not a diagnostic algorithm involving human readers or AI.

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

Not applicable. The INOmax DSIR is a medical device for delivering and monitoring nitric oxide, not a standalone diagnostic algorithm. Its performance was tested as a standalone system and in conjunction with other respiratory care devices.

7. The Type of Ground Truth Used

The "ground truth" for this non-clinical testing was based on:

• Manufacturer's specifications: The INOmax DSIR was expected to "perform within published specifications."
• Manufacturer's recommendations: The respiratory care devices were set up and calibrated "according to the manufacturer's recommendations."
• Expected compatibility: The overall aim was to conclude that the INOmax DSIR and the three respiratory care devices are compatible.

8. The Sample Size for the Training Set

Not applicable. This device is a hardware and software system for medical gas delivery and monitoring, not a machine learning model that requires a training set.

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

Not applicable, as there was no training set.

Ask a specific question about this device

The INOmax DS delivery system delivers INOmax® (nitric oxide of inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. It uses a specially designed injector module, which enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with most ventilators.

The INOmax DS provides continuous integrated monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system.

The INOmax DS incorporates a battery that provides up to 6 hours of uninterrupted NO delivery in the absence of an external power source.

The INOmax DS includes a backup NO delivery capability that provides a fixed flow of 250 mL/min of NO which along with user supplied 10 L/min of oxygen provides 20 ppm in the gas flow to a patients breathing circuit. It may also use the INOblender for backup.

The target patient population is controlled by the drug labeling for INOmax and is currently neonates. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and secondary targeted clinical setting is the transport of neonates.

The INO Therapeutics INOmax DS represents the continuing evolution of the Datex-Ohmeda (now GE Healthcare) INOvent Delivery System design. Its published performance specifications are not significantly different from the INOvent. The INOmax DS design incorporates a reconfiguration of hardware, electronic circuitry and software resulting in a more compact, stylish, modern, user-friendly and easier manufactured product.

The INOmax DS delivery system delivers INOmax® (nitric oxide of inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. It uses a specially designed iniector module, which enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with most ventilators.

The INOmax DS provides continuous integrated monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system. The INOmax DS incorporates a battery that provides up to 6 hours of uninterrupted NO delivery in the absence of an external power source.

The INOmax DS includes a backup NO delivery capability that provides a fixed flow of 250 mL/min of NO which along with user supplied 10 L/min of oxygen provides 20 ppm in the gas flow to a patients breathing circuit. It may also use the INOblender for backup.

The provided text describes the INOmax DS (Delivery System), a nitric oxide administration apparatus. However, it explicitly states that clinical studies were not required to support substantial equivalence for this device. Therefore, information regarding acceptance criteria derived from clinical studies, comparative effectiveness studies, or clinical ground truth establishment is not available within the provided document.

The document primarily focuses on non-clinical tests and the device's technological equivalence to a predicate device.

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

Acceptance Criteria and Device Performance

Since clinical studies were not required for this 510(k) submission, there are no specific performance acceptance criteria or reported device performance metrics from clinical trials mentioned. The manufacturer's conclusion is that the INOmax DS is "as safe, as effective, and performance is substantially equivalent to the predicate device."

Other Information

Due to the lack of clinical studies, much of the requested information is not present in the provided document.

2. Sample sizes used for the test set and the data provenance: Not applicable, as no clinical test set for performance evaluation is mentioned. Non-clinical testing details (e.g., number of units tested, specific data provenance) are not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical test set requiring expert ground truth is mentioned.
4. Adjudication method for the test set: Not applicable, as no clinical test set is mentioned.
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 nitric oxide delivery system, not an AI-assisted diagnostic tool. No MRMC study was conducted or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device for nitric oxide delivery, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no clinical ground truth establishment is mentioned. The primary basis for equivalence is technological similarity and compliance with voluntary standards and internal quality assurance measures, rather than a clinical ground truth.
8. The sample size for the training set: Not applicable, as this is a medical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

The INOmax DS delivery system delivers INOmax® (nitric oxide of inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. It uses a specially designed injector module, which enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with most ventilators.

The INOmax DS provides continuous integrated monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system.

The INOmax DS incorporates a battery that provides up to 6 hours of uninterrupted NO delivery in the absence of an external power source.

The INOmax DS includes a backup NO delivery capability that provides a fixed flow of 250 mL/min of NO which along with user supplied 10 L/min of oxygen provides 20 ppm in the gas flow to a patients breathing circuit. It may also use the INOblender for backup.

The target patient population is controlled by the drug labeling for INOmax and is currently neonates. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and secondary targeted clinical setting is the transport of neonates.

The INOmax DS Delivery System provides a constant dose of INOmax (nitric oxide) therapy gas into the inspiratory limb of the ventilator circuit. The INOmax DS Delivery System uses a "dual-channel" design to ensure the safe delivery of INOmax.

The first channel has the delivery CPU, the flow controller and the injector module to ensure the accurate delivery of NO. The second channel is the monitoring system, which includes a separate monitor CPU, the gas cells (NO, NO2 and O2 cells) and the user interface including the display and alarms. The dual-channel approach to delivery and monitoring permits INOmax delivery independent of monitoring but also allows the monitoring system to shutdown INOmax delivery if it detects a fault in the delivery system such that the NO concentration could become greater than 100 ppm. INOmax drug is stored as a gas mixture of NO/N2 in an aluminum cylinder at a nominal pressure of 2200 psig.

The cylinder is attached to a high pressure requlator which incorporates a pressure gauge that indicates cylinder pressure when the cylinder valve is open. The cylinder regulator is attached via tubing to the INOmax DS Delivery System using one of the two NO/NO2 quick connect inlets on the back of the machine.

The INOmax enters the back of the INOmax DS Delivery System, passes through a filter, then a safety shutoff valve, which is open under normal operations.

An injector module is placed in the ventilator gas flow between the ventilator inspiratory outlet and the humidifier. Based on the ventilator flow, the INOmax cylinder concentration and set INOmax dose, the proportional solenoid delivers INOmax into the ventilator circuit via the injector module. This allows the INOmax DS Delivery System to deliver a constant dose of INOmax regardless of the ventilator flow pattern or breath rate.

A flow sensor inside the INOmax DS Delivery Systém also monitors the NO flow out of the machine. A check valve is included prior to the INOmax DS Delivery System drug outlet to prevent pressure effects from the ventilator breathing circuit interfering with the NO flow sensor reading.

The INOmax DS Delivery System gas monitoring system provides monitored values for inspired NO, NO2, and O2 The sample gas is withdrawn from the breathing circuit and goes through a water trap to remove excess water, a zero valve, a sample pump and finally a sample flow sensor to the gas monitoring cells. The zero valve allows the gas cells to be zeroed (during low calibration) without having to disconnect the sample line from the breathing circuit. The pump and sample flow sensor ensure a constant sample gas flow rate is maintained to the monitoring cells.

The gas monitoring cells are electrochemical; they are specific to each gas and provide an electronic signal, which is proportional to the concentration of gas present.

If the delivery system does go into shutdown, the INOmax DS Delivery System has an integrated backup function which provides a fixed flow of INOmax (0.25L/min) into the injector module using a pneumatic on/off switch and a restrictor built into the delivery side of the system. This fixed flow of INOmax will provide 20 ppm of NO when the continuous ventilator gas flow is 10 L/min. The backup is only for short term use until a replacement delivery system can be obtained. An alarm will warn the user if the backup system is turned on while the main delivery system is in use for INOmax delivery.

The provided text describes a medical device, the INOmax DS (Delivery System), and its regulatory submission (K0909258). However, it does not contain the specific details required to complete your request for acceptance criteria and the comprehensive study information.

The document is a 510(k) summary for a medical device (nitric oxide administration apparatus). A 510(k) submission typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive clinical study data with detailed acceptance criteria for diagnostic performance metrics like accuracy, sensitivity, or specificity, as would be common for AI/ML devices.

Here's a breakdown of what can be extracted and what is missing, based on your requested points:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: The document mentions that "Testing indicated the INOmax DS Delivery System met its design input specifications, design output specifications and risk analysis requirements." (page 4) and that "The INOmax DS Delivery System was designed to comply with the applicable portions of the following product standards" (page 5, listing IEC, ASTM, and FDA guidance documents). There are also specific performance specifications for gas monitoring and NO delivery (pages 1-2).
• Reported Device Performance: The document provides specifications for the INOmax DS in comparison to a predicate device (INOvent Delivery System). These are more akin to design specifications rather than performance results from a clinical study for diagnostic accuracy.

What's Missing for a comprehensive table:
The document does not explicitly state "acceptance criteria" in a pass/fail quantifiable sense for a study evaluating diagnostic performance. It talks about meeting design specifications and complying with standards, which are different. It also does not provide specific numerical results from a study that can be directly compared against acceptance criteria for metrics like sensitivity, specificity, or accuracy, as would be relevant for an AI/ML device.

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

• Sample Size for Test Set: This information is not provided. The document mentions "Validation of ventilators" as part of testing (page 4), but no details on the number of cases or data points, or how the test set was constituted.
• Data Provenance: This information is not provided. There's no mention of country of origin, or if the data was retrospective or prospective.

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

• This information is not provided. The device is an administration and monitoring system, not one that requires human expert interpretation for ground truth in the way an AI diagnostic tool would.

4. Adjudication method for the test set

• This information is not provided. Not applicable in the context of this device and the type of testing 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

• Such a study was not done and is not applicable. This device is not an AI diagnostic tool that assists human readers.

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

• This concept is not applicable in the context of this device. The device is a system for delivering and monitoring nitric oxide; its "performance" is about accurate gas delivery, measurement, and alarms, not AI algorithm output.

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

• "Ground truth" as understood for diagnostic AI/ML devices (e.g., pathology for disease presence) is not applicable here. The "ground truth" for this device's performance would be the actual concentration of gases, flow rates, and system functionality as measured by calibrated instruments and against established engineering specifications and physical principles.

8. The sample size for the training set

• This information is not provided. The document describes a medical device, not an AI/ML algorithm that is "trained" on a dataset in the typical sense.

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

• This information is not provided. Not applicable as per point 8.

Summary of what the document does provide regarding "testing":

The document states:

• "Testing indicated the INOmax DS Delivery System met its design input specifications, design output specifications and risk analysis requirements." (page 4)
• "Testing completed included: Validation of ventilators." (page 4)
• The device was designed to comply with several product standards (IEC, ASTM, FDA guidance) (page 5).
• It provides a comparison of specifications between the INOmax DS and a predicate device, for features like battery backup duration, physical dimensions, ventilator compatibility, NO delivery resolution/accuracy, and gas monitoring resolution/accuracy (pages 1-2). For example, it lists INOmax DS NO accuracy as "+/- 20% indicated or 2 ppm whichever greater" and NO accuracy for gas monitoring as "+/- 20% of reading +0.5 ppm" (page 1-2). These could be interpreted as performance metrics, but they are stated specifications rather than results from a specific study.

Conclusion:

The provided K0909258 document is a 510(k) summary for a medical device that delivers and monitors Nitric Oxide. It focuses on demonstrating substantial equivalence to predicate devices and adherence to design specifications and relevant standards. It is not a submission for an AI/ML diagnostic or assistive device and therefore does not contain the detailed clinical study data, acceptance criteria for diagnostic metrics, or information about ground truth establishment, expert adjudication, or reader studies that your request asks for. The "testing" mentioned is likely engineering verification and validation testing to ensure the device performs according to its technical specifications and safety requirements, rather than a clinical study establishing diagnostic performance against a ground truth.

Ask a specific question about this device

The INOmax DS delivery system delivers INOmax® (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. It uses a specially designed injector module, which enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with most ventilators.

The INOmax DS provides continuous integrated monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system.

The INOmax DS incorporates a battery that provides up to 6 hours of uninterrupted NO delivery in the absence of an external power source.

The INOmax DS includes a backup NO delivery capability that provides a fixed flow of 250 mL/min of NO which along with user supplied 10 L/min of oxygen provides 20 ppm in the gas flow to a patients breathing circuit. It may also use the INOblender for backup.

The target patient population is controlled by the drug labeling for INOmax and is currently neonates. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and secondary targeted clinical setting is the transport of neonates.

The INOmax DS (Delivery System) provides a constant dose of INOmax (nitric oxide) therapy gas into the inspiratory limb of the ventilator circuit. The INOmax DS (Delivery System) uses a "dual-channel" design to ensure the safe delivery of INOmax.

The first channel has the delivery CPU, the flow controller and the injector module to ensure the accurate delivery of NO. The second channel is the monitoring system, which includes a separate monitor CPU, the gas cells (NO, NO2 and O2 cells) and the user interface including the display and alarms. The dual-channel approach to delivery and monitoring permits INOmax delivery independent of monitoring but also allows the monitoring system to shutdown INOmax delivery if it detects a fault in the delivery system such that the NO concentration could become greater than 100 ppm. INOmax drug is stored as a gas mixture of NO/N2 in an aluminum cylinder at a nominal pressure of 2200 psig.

The cylinder is attached to a high pressure regulator which incorporates a pressure gauge that indicates cylinder pressure when the cylinder valve is open. The cylinder requlator is attached via tubing to the INOmax DS (Delivery System) using one of the two NO/NO2 quick connect inlets on the back of the machine.

The INOmax enters the back of the INOmax DS (Delivery System), passes through a filter, then a safety shutoff valve, which is open under normal operations.

An injector module is placed in the ventilator gas flow between the ventilator inspiratory outlet and the humidifier. Based on the ventilator flow, the INOmax cylinder concentration and set INOmax dose, the proportional solenoid delivers INOmax into the ventilator circuit via the injector module. This allows the INOmax DS (Delivery Svstem) to deliver a constant dose of INOmax regardless of the ventilator flow pattern or breath rate.

A flow sensor inside the INOmax DS (Delivery System) also monitors the NO flow out of the machine. A check valve is included prior to the INOmax DS (Delivery System) drug outlet to prevent pressure effects from the ventilator breathing circuit interfering with the NO flow sensor reading.

The INOmax DS (Delivery System) gas monitoring system provides monitored values for inspired NO, NO2, and O2 The sample gas is withdrawn from the breathing circuit and goes through a water trap to remove excess water, a zero valve, a sample pump and finally a sample flow sensor to the gas monitoring cells. The zero valve allows the gas cells to be zeroed (during low calibration) without having to disconnect the sample line from the breathing circuit. The pump and sample flow sensor ensure a constant sample gas flow rate is maintained to the monitoring cells.

The gas monitoring cells are electrochemical; they are specific to each gas and provide an electronic signal, which is proportional to the concentration of gas present.

If the delivery system does go into shutdown, the INOmax DS (Delivery System) has an integrated backup function which provides a fixed flow of INOmax (0.25L/min) into the injector module using a pneumatic on/off switch and a restrictor built into the delivery side of the system. This fixed flow of INOmax will provide 20 ppm of NO when the continuous ventilator gas flow is 10 L/min. The backup is only for short term use until a replacement delivery system can be obtained. An alarm will warn the user if the backup system is turned on while the main delivery system is in use for INOmax delivery.

This document describes the INOmax DS (Delivery System), a nitric oxide administration apparatus. However, it does not contain information about acceptance criteria or a study that specifically proves the device meets acceptance criteria in the context of diagnostic accuracy, which is typically what those terms imply for AI/ML devices.

Instead, this submission is a 510(k) for a medical device (not an AI/ML algorithm) that relies on demonstrating substantial equivalence to a predicate device. The "acceptance criteria" here are more akin to engineering specifications and performance characteristics compared against the predicate device, rather than diagnostic performance metrics. The "study" refers to engineering testing and validation to ensure the device meets its design specifications and complies with relevant standards.

Therefore, I cannot populate the requested table and sections as they would apply to an AI/ML diagnostic device. I will extract the relevant information regarding performance specifications and testing as presented for this hardware device.

Here's the breakdown of what is available in the provided text:

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

The document provides a comparison table between the INOvent Delivery System (predicate) and the INOmax DS (Delivery System). These are more akin to performance specifications than acceptance criteria in a diagnostic sense.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document describes engineering and software validation, not a clinical study with a "test set" in the context of diagnostic performance.

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

This information is not provided and is not relevant for this type of device submission, which focuses on hardware and software function, not diagnostic interpretation.

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

This information is not provided and is not relevant for this type of device submission.

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

An MRMC study was not done. This device is a hardware delivery system, not an AI/ML diagnostic tool that assists human readers.

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

This is not applicable as the device is a hardware delivery system, not an algorithm.

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

The "ground truth" for this device's performance validation is its design input specifications and risk analysis requirements. The testing confirmed that the device performed according to these engineering specifications and safety requirements, and in compliance with applicable standards.

8. The sample size for the training set

This information is not provided and not applicable. This is not an AI/ML device that requires a "training set."

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

This is not applicable as the device is a hardware delivery system, not an AI/ML algorithm.

Ask a specific question about this device

The INOmax DS delivery system delivers INOmax® (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. It uses a specially designed injector module, which enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with most ventilators.

The INOmax DS provides continuous integrated monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system.

The INOmax DS incorporates a battery that provides up to 6 hours of uninterrupted NO delivery in the absence of an external power source.

The INOmax DS includes a backup NO delivery capability that provides a fixed flow of 250 mL/min of NO which along with user supplied 10 L/min of oxygen provides 20 ppm in the gas flow to a patients breathing circuit. It may also use the INOblender for backup.

The target patient population is controlled by the drug labeling for INOmax and is currently neonates. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and secondary targeted clinical setting is the transport of neonates.

The INOmax DS provides a constant dose of INOmax (nitric oxide) therapy gas into the inspiratory limb of the ventilator circuit. The INOmax DS uses a "dual-channel" design to ensure the safe delivery of INOmax.

The first channel has the delivery CPU, the flow controller and the injector module to ensure the accurate delivery of NO. The second channel is the monitoring system, which includes a separate monitor CPU, the gas cells (NO, NO2 and O2 cells) and the user interface including the display and alarms. The dual-channel approach to delivery and monitoring permits INOmax delivery independent of monitoring but also allows the monitoring system to shutdown INOmax delivery if it detects a fault in the delivery system such that the NO concentration could become greater than 100 ppm. INOmax drug is stored as a gas mixture of NO/N2 in an aluminum cylinder at a nominal pressure of 2200 psig.

The cylinder is attached to a high pressure regulator which incorporates a pressure gauge that indicates cylinder pressure when the cylinder valve is open. The cylinder regulator is attached via tubing to the INOmax DS using one of the two NO/NO2 quick connect inlets on the back of the machine.

The INOmax enters the back of the INOmax DS, passes through a filter, then a safety shutoff valve, which is open under normal operations.

An injector module is placed in the ventilator gas flow between the ventilator inspiratory outlet and the humidifier. Based on the ventilator flow, the INOmax cylinder concentration and set INOmax dose, the proportional solenoid delivers INOmax into the ventilator circuit via the injector module. This allows the INOmax DS to deliver a constant dose of INOmax regardless of the ventilator flow pattern or breath rate.

A flow sensor inside the INOmax DS also monitors the NO flow out of the machine. A check valve is included prior to the INOmax DS drug outlet to prevent pressure effects from the ventilator breathing circuit interfering with the NO flow sensor reading.

The INOmax DS gas monitoring system provides monitored values for inspired NO, NO2, and O2. The sample gas is withdrawn from the breathing circuit and goes through a water trap to remove excess water, a zero valve, a sample pump and finally a sample flow sensor to the gas monitoring cells. The zero valve allows the gas cells to be zeroed (during low calibration) without having to disconnect the sample line from the breathing circuit. The pump and sample flow sensor ensure a constant sample gas flow rate is maintained to the monitoring cells.

The gas monitoring cells are electrochemical; they are specific to each gas and provide an electronic signal, which is proportional to the concentration of gas present.

If the delivery system does go into shut down, the INOmax DS has an integrated backup function which provides a fixed flow of INOmax (0.25L/min) into the injector module using a pneumatic on/off switch and a restrictor built into the delivery side of the system. This fixed flow of INOmax will provide 20 ppm of NO when the continuous ventilator gas flow is 10 Limin. The backup is only for short term use until a replacement delivery system can be obtained. An alarm will warn the user if the backup system is turned on while the main delivery system is in use for INOmax delivery.

The provided document is a 510(k) summary for the INOmax DS (Delivery System), indicating its substantial equivalence to previously cleared predicate devices. It describes the device's technical specifications and intended use, but it does not contain information about a study that establishes acceptance criteria through performance metrics like sensitivity, specificity, or accuracy, nor does it detail a study involving human readers or expert consensus for ground truth.

Instead, the document focuses on demonstrating that the INOmax DS meets various engineering and safety standards, and that its performance is comparable to predicate devices. The "acceptance criteria" here are primarily framed as compliance with design specifications and relevant medical device standards.

Here's an attempt to extract the requested information based on the provided text, recognizing that much of it is not explicitly present for a typical AI/diagnostic device study.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the design input and output specifications, and compliance with various standards. The "performance" is described in terms of the device's functional capabilities and its similarity to predicate devices.

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

The document states "Testing indicated the INOmax DS met its design input specifications, design output specifications and risk analysis requirements. Testing completed included: Validation of ventilators." However, it does not specify:

• The exact sample size for the ventilator validation or other electrical/mechanical tests.
• The data provenance (e.g., country of origin, retrospective/prospective). This type of device's "testing" is typically bench testing and laboratory validation, not clinical data collection on patients in the way a diagnostic AI would be.

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 device is an electro-mechanical gas delivery system, not a diagnostic tool requiring expert interpretation of images or other clinical data for "ground truth" establishment in the typical sense of AI/medical imaging studies. Ground truth here would be established by reference instruments and engineering standards.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not provided and is not applicable for this type of device validation. Adjudication methods are typically used in clinical studies comparing human interpretations.

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

No, an MRMC study was not done. This document describes a device for delivering therapeutic gas, not an AI-powered diagnostic tool that assists human readers.

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

Yes, implicitly. The device is a "standalone" system in that it performs its functions (gas delivery, monitoring) automatically based on user settings and its internal algorithms. Its performance is evaluated against engineering specifications and predicate devices, not typically in a human-in-the-loop context for a diagnostic output. The "testing" mentioned ("Validation of ventilators") would inherently be a standalone evaluation of the device's ability to interface and deliver gas with various ventilators.

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

For this type of device, the "ground truth" for performance evaluations would be:

• Reference measurements: From calibrated scientific instruments for gas concentrations (NO, NO2, O2), flow rates, pressure, etc.
• Engineering specifications: The device is designed to meet specific numerical parameters, and testing validates these parameters using metrology.
• Standard compliance: Adherence to national and international medical device standards (e.g., IEC 60601 series, ASTM, CGA).
• Predicate device performance: Functional equivalence to prior cleared devices serves as a benchmark.

8. The Sample Size for the Training Set

This information is not applicable and not provided. This is not an AI/machine learning device that requires a "training set." Its functionality is based on established physical principles and control algorithms, not learned patterns from data.

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

This information is not applicable as there is no training set for this device.

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The INOmax DS delivery system delivers INOmax® (nitric oxide of inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. It uses a specially designed injector module, which enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with most ventilators.

The INOmax DS provides continuous integrated monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system.

The INOmax DS incorporates a battery that provides up to 6 hours of uninterrupted NO delivery in the absence of an external power source.

The INOmax DS includes a backup NO delivery capability that provides a fixed flow of 250 mL/min of NO which along with user supplied 10 L/min of oxygen provides 20 ppm in the gas flow to a patients breathing circuit. It may also use the INOblender for backup.

The target patient population is controlled by the drug labeling for INOmax and is currently neonates. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and secondary targeted clinical setting is the transport of neonates.

The INOmax DS provides a constant dose of INOmax (nitric oxide) therapy gas into the inspiratory limb of the ventilator circuit. The INOmax DS uses a "dual-channel" design to ensure the safe delivery of INOmax. The first channel has the delivery CPU, the flow controller and the injector module to ensure the accurate delivery of NO. The second channel is the monitoring system, which includes a separate monitor CPU, the gas cells (NO, NO2 and O2 cells) and the user interface including the display and alarms. The dual-channel approach to delivery and monitoring permits INOmax delivery independent of monitoring but also allows the monitoring system to shutdown INOmax delivery if it detects a fault in the delivery system such that the NO concentration could become greater than 100 ppm. INOmax drug is stored as a gas mixture of NO/N2 in an aluminum cylinder at a nominal pressure of 2200 psig. The cylinder is attached to a high pressure regulator which incorporates a pressure gauge that indicates cylinder pressure when the cylinder valve is open. The cylinder regulator is attached via tubing to the INOmax DS using one of the two NO/NO2 quick connect inlets on the back of the machine. The INOmax enters the back of the INOmax DS, passes through a filter, then a safety shutoff valve, which is open under normal operations. An injector module is placed in the ventilator gas flow between the ventilator inspiratory outlet and the humidifier. Based on the ventilator flow, the INOmax cylinder concentration and set INOmax dose, the proportional solenoid delivers INOmax into the ventilator circuit via the injector module. This allows the INOmax DS to deliver a constant dose of INOmax regardless of the ventilator flow pattern or breath rate. A flow sensor inside the INOmax DS also monitors the NO flow out of the machine. A check valve is included prior to the INOmax DS drug outlet to prevent pressure effects from the ventilator breathing circuit interfering with the NO flow sensor reading. The INOmax DS gas monitoring system provides monitored values for inspired NO, NO2, and O2 The sample gas is withdrawn from the breathing circuit and goes through a water trap to remove excess water, a zero valve, a sample pump and finally a sample flow sensor to the gas monitoring cells. The zero valve allows the gas cells to be zeroed (during low calibration) without having to disconnect the sample line from the breathing circuit. The pump and sample flow sensor ensure a constant sample gas flow rate is maintained to the monitoring cells. The gas monitoring cells are electrochemical; they are specific to each gas and provide an electronic signal, which is proportional to the concentration of the gas present. If the delivery system does go into shut down, the INOmax DS has an integrated backup function which provides a fixed flow of INOmax (0.25L/min) into the injector module using a pneumatic on/off switch and a restrictor built into the delivery side of the system. This fixed flow of INOmax will provide 20 ppm of NO when the continuous ventilator gas flow is 10 L/min. The backup is only for short term use until a replacement delivery system can be obtained. An alarm will warn the user if the backup system is turned on while the main delivery system is in use for INOmax delivery.

The provided document describes the INOmax DS (Delivery System), a device for delivering nitric oxide (NO) therapy, primarily to neonates. The document is a 510(k) summary for a premarket notification (K070867). It details the device's characteristics, its similarities to a predicate device, and the testing conducted to ensure its compliance with design specifications and applicable standards.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly present a table of acceptance criteria with corresponding performance metrics in a pass/fail format typical of many medical device studies for software algorithms. Instead, it describes compliance with various standards and design specifications. The performance is primarily characterized by comparing the INOmax DS to its predicate device (INOvent Delivery System) and outlining its features.

However, based on the narrative, we can infer some key performance aspects and their intended or reported capabilities:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document refers to "Testing" that indicated the INOmax DS met its design input, output, and risk analysis requirements. It also states "Validation of ventilators" was performed, and "newly validated ventilators have been qualified with the INOmax DS."

• Sample Size for Test Set: Not explicitly stated for any specific test. The phrase "Validation of ventilators" implies a test set of ventilators, but the number is not given.
• Data Provenance: Not specified. Given the nature of a 510(k) submission in the US, the testing would generally be expected to be conducted under a US-based quality system, but the geographic origin of the specific test data is not detailed.
• Retrospective or Prospective: Not specified. Given the nature of device validation, these would typically be prospective tests conducted on the manufactured device.

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

This information is not applicable to this type of device submission. The INOmax DS is a physical medical device (gas delivery system), not an AI/software algorithm that requires expert interpretation for establishing ground truth in a diagnostic or image-based context. The "ground truth" for this device would be established by physical measurements against engineering specifications and validated standards.

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

This information is not applicable. Adjudication methods like '2+1' or '3+1' are typically used in clinical studies or for establishing ground truth from multiple expert readings in diagnostic imaging or similar fields. For a device like the INOmax DS, performance is verified through objective measurements and engineering standards, not through adjudication of expert opinions.

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 information is not applicable. An MRMC study is designed to evaluate the performance of diagnostic systems (often AI-assisted) by comparing multiple human readers' interpretations of multiple cases. The INOmax DS is a therapeutic gas delivery system, not a diagnostic imaging or AI-based diagnostic tool.

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

This information is not applicable. The INOmax DS is a physical device with integrated hardware and software for gas delivery and monitoring. It is not an "algorithm only" device, nor is its performance typically evaluated in a standalone "algorithm only" context, as it functions as a complete system with human interaction (setting dose, monitoring, etc.).

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

For this device, the "ground truth" is derived from:

• Engineering Specifications: The device's performance against its own design input and output specifications.
• Physical Measurements: Quantifiable measurements of gas concentration, flow rates, battery life, and alarm functions.
• Compliance with Standards: Verification against established industry and regulatory standards (e.g., IEC, ASTM, FDA guidance documents).

8. The sample size for the training set

This information is not applicable. The INOmax DS is not an AI/machine learning device that requires a "training set" in the conventional sense. The device's operation is based on predefined algorithms and control logic, not learned patterns from data.

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

This information is not applicable for the same reasons as in point 8.

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The INOmax DS delivery system delivers INOmax® (nitric oxide of inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. It uses a specially designed injector module, which enables tracking of the ventilator wayeforms and the delivery of a synchronized and proportional dose of NO. It may be used with most ventilators.

The INOmax DS provides continuous integrated monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system.

The INOmax DS incorporates a battery that provides up to 6 hours of uninterrupted NO delivery in the absence of an external power source.

The INOmax DS includes a backup NO delivery capability that provides a fixed flow of 250 mL/min of NO which along with user supplied 10 L/min of oxygen provides 20 ppm in the gas flow to a patients breathing circuit. It may also use the INOblender for backup.

The target patient population is controlled by the drug labeling for INOmax and is currently neonates. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and secondary targeted clinical setting is the transport of neonates.

The INOmax DS provides a constant dose of INOmax (nitric oxide) therapy gas into the inspiratory limb of the ventilator circuit. The INOmax DS uses a "dual-channel" design to ensure the safe delivery of INOmax.

The first channel has the delivery CPU, the flow controller and the injector module to ensure the accurate delivery of NO. The second channel is the monitoring system, which includes a separate monitor CPU, the gas cells (NO, NO2, and O2 cells) and the user interface including the display and alarms. The dual-channel approach to delivery and monitoring permits INOmax delivery independent of monitoring but also allows the monitoring system to shutdown INOmax delivery if it detects a fault in the delivery system such that the NO concentration could become greater than 100 ppm. INOmax drug is stored as a gas mixture of NO/N2 in an aluminum cylinder at a nominal pressure of 2200 psig.

The cylinder is attached to a high pressure regulator which incorporates a pressure gauge that indicates cylinder pressure when the cylinder valve is open. The cylinder regulator is attached via tubing to the INOmax DS using one of the two NO/N2 quick connect inlets on the back of the machine.

The INOmax enters the back of the INOmax DS, passes through a filter. then a safety shutoff valve, which is open under normal operation.

An injector module is placed in the ventilator gas flow between the ventilator inspiratory outlet and the humidifier. Based on the ventilator flow, the INOmax cylinder concentration and set INOmax dose, the proportional solenoid delivers INOmax into the ventilator circuit via the injector module. This allows the INOmax DS to deliver a constant dose of INOmax regardless of the ventilator flow pattern or breath rate.

A flow sensor inside the INOmax DS also monitors the NO flow out of the machine. A check valve is included prior to the INOmax DS drug outlet to prevent pressure effects from the ventilator breathing circuit interfering with the NO flow sensor reading.

The INOmax DS gas monitoring system provides monitored values for inspired NO, NO2, and O2. The sample gas is withdrawn form the breathing circuit and goes through a water trap to remove excess water, a zero valve, a sample pump and finally a sample flow sensor to the gas monitoring cells. The zero valve allows the gas cells to be zeroed (during low calibration) without having to disconnect the sample line from the breathing circuit. The pump and sample flow sensor ensure a constant sample gas flow rate is maintained to the monitoring cells.

The gas monitoring cells are electrochemical; they are specific to each gas and provide an electronic signal, which is proportional to the concentration of the gas present.

If the delivery system does go into shut down, the INOmax DS has an integrated backup function which provides a fixed flow of INOmax (0.25L/min) into the injector module using a pneumatic on/off switch and a restrictor built into the delivery side of the system. This fixed flow of INOmax will provide 20 ppm of NO when the continuous ventilator gas flow is 10 L/min. The backup is only for short term use until a replacement delivery system can be obtained. An alarm will warn the user if the backup system is turned on while the main delivery system is in use for INOmax delivery.

The INOmax DS is a Nitric Oxide Administration Apparatus designed to deliver INOmax (nitric oxide for inhalation) therapy gas to neonates in clinical settings such as the Neonatal Intensive Care Unit (NICU) and during transport. The device ensures a constant concentration of nitric oxide (NO) as set by the user, throughout the inspired breath, utilizing a dual-channel design for delivery and monitoring. It also includes integrated monitoring of O2, NO2, and NO, and a comprehensive alarm system. A key safety feature is a 6-hour battery backup and a fixed-flow backup NO delivery capability.

Here's an analysis of its acceptance criteria and the study proving it:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify a "test set" in the context of clinical or patient data. The testing described includes:

• Performance bench testing
• Integrity testing
• Environmental and mechanical testing
• Validation against ventilators testing
• Product standards certification testing

These are technical engineering and laboratory tests, not tests with a human patient cohort. Therefore, concepts like sample size, country of origin, retrospective/prospective data provenance (for patient data) are not applicable here. The data provenance would be from internal lab testing by INC Therapeutics.

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

This is not applicable as the device is a piece of medical equipment (Nitric Oxide Administration Apparatus). The "ground truth" for its performance is established through objective engineering specifications, performance standards (e.g., IEC 60601-1), and comparisons to a predicate device's measured performance. Validation is against these technical specifications, not against expert medical diagnoses or interpretations.

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

This is not applicable for the type of technical performance testing described. Adjudication methods are typically used in clinical studies for ambiguous cases, often involving multiple experts to reach a consensus on diagnostic interpretations. The performance of the INOmax DS is measured against defined technical parameters and standards.

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 is not applicable. The INOmax DS is a medical device for delivering therapy gas and monitoring physiological parameters, not an AI-powered diagnostic tool requiring human reader interpretation of images or other data. Therefore, an MRMC study and analysis of human reader improvement with AI assistance are irrelevant to this device.

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

This is not applicable as the device is not an algorithm or AI system. It is a standalone medical device that performs its intended function independently, delivering nitric oxide and monitoring gases. While a human operator sets parameters and monitors the device, the core function (gas delivery, monitoring, alarms) is performed by the device itself (algorithm only without human-in-the-loop performance is a concept for AI driven diagnostics).

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

The "ground truth" for the INOmax DS's performance is based on:

• Design input specifications: Pre-defined technical requirements for the device.
• Design output specifications: The technical characteristics and performance generated by the design process.
• Risk analysis requirements: Ensuring safety and mitigating identified risks.
• Applicable product standards: Compliance with industry standards like FDA Guidance, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-1-8, CGA V-1, ASTM F-1462-93, ASTM F-1054-87.
• Predicate device performance: Comparison to the established performance of the Ohmeda INOvent Delivery System.

These are primarily objective, quantitative engineering and regulatory criteria, rather than clinical 'ground truth' derived from patient outcomes or pathology.

8. The sample size for the training set

This is not applicable. The INOmax DS is a hardware-based medical device with integrated software/firmware for control and monitoring, not a machine learning or AI model. Therefore, there is no "training set" in the context of data used to train an algorithm.

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

This is not applicable for the reasons outlined in point 8. The device's functionality is designed, engineered, and then verified against its specifications and relevant standards through testing.

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