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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.

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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, NO3, 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 delivery system for nitric oxide and its compatibility with additional ventilators. The study discussed is a non-clinical test to establish substantial equivalence for the updated device rather than an AI-powered diagnostic tool, therefore many of the requested criteria are not applicable.

Here's an analysis of the provided information, focusing on the relevant sections and explicitly stating when information is not applicable (N/A) for this type of device and study:

1. A table of acceptance criteria and the 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)

• Sample Size for Test Set:
  • Five INOmax DSIR settings were used: 0 (baseline), 1, 5, 20, 40, and 80 ppm.
  • These settings were applied for each setting and mode of ventilation/patient cannula for the five additional respiratory care devices.
  • The "Backup mode" was also tested for each.
  • (Note: The document doesn't specify the number of times each setting/mode combination was tested or the duration of each test).
• Data Provenance: Not specified, but implied to be from laboratory testing related to the submitter (INO Therapeutics/Ikaria). The study is prospective in that it was conducted specifically for this submission.

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)

N/A. This was a non-clinical engineering and performance study of a medical device, not a diagnostic study requiring expert human interpretation of data for ground truth. The "ground truth" was the physical performance of the device against predefined technical specifications.

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

N/A. As this was a non-clinical performance study, there was no need for human adjudication of results in the way it's applied in diagnostic studies. The results were measured and recorded against established device specifications.

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

N/A. This study is not an MRMC comparative effectiveness study, nor does it involve AI assistance for human readers. It's a non-clinical compatibility and performance test of a medical device.

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

N/A. This device does not have an "algorithm only" component in the diagnostic sense that would be tested for standalone performance. The device itself is the "system" being tested.

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

The "ground truth" for this non-clinical study was the published specifications of the INOmax DSIR and the compatibility requirements for its operation with the selected ventilators. The testing aimed to demonstrate that the device performed within these established specifications.

8. The sample size for the training set

N/A. There is no mention of a training set as this is a non-clinical device performance study, not an AI or machine learning model development.

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

N/A. There is no training set for this type of non-clinical device performance study.

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 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. The second channel is the monitoring system, which includes a separate monitor CPU, the gas cells monitoring systems, and the user interface including the display and alarms. The dual channel approach to delivery and monitoring permits delivery independent of monitoring but also allows the monitoring system to shutdown INOmax delivery if it detects a fault in the monitoring system that could lead to the NO concentration becoming 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 and 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.

This document describes the INOmax DS delivery system, a device for delivering nitric oxide (NO) for inhalation. The submission is a 510(k) premarket notification, indicating the device is substantially equivalent to previously cleared predicate devices.

1. Table of Acceptance Criteria & Reported Device Performance

The acceptance criteria are implied by the "Testing" section, which states "The testing indicated the INOmax DS met its design input specifications, design output specifications and risk analysis requirements." The document also lists applicable standards it was designed to comply with. However, specific numerical acceptance criteria and corresponding reported performance values are not explicitly laid out in a table format in the provided text. Instead, the document focuses on demonstrating substantial equivalence to a predicate device and adherence to design specifications and standards.

The table below summarizes key specifications of the INOmax DS compared to its predicate, the INOvent Delivery System, which implicitly serves as the performance benchmark for substantial equivalence.

Note: The "acceptance criteria" above are derived from the specifications of the predicate device, the INOvent Delivery System, as the INOmax DS claims substantial equivalence. Differences are highlighted in bold within the "Reported Device Performance" column.

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

The document does not explicitly state a "test set" in the context of clinical data for algorithmic performance. This submission is for a medical device (nitric oxide delivery system) rather than an AI/ML algorithm that would typically involve test sets of patient data.

The "testing" mentioned refers to engineering validation and verification of the device's design specifications and compliance with standards. It also mentions "Validation of ventilators" in relation to the device's compatibility. Specific sample sizes for such validation tests are not provided in this summary.

Data provenance is not applicable in the typical sense of clinical retrospective/prospective data as this is a device submission.

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

Not applicable. This is not a study requiring expert-established ground truth for an AI/ML algorithm. The "ground truth" for this device relates to its adherence to engineering specifications and regulatory standards.

4. Adjudication Method for the Test Set

Not applicable, as there is no mention of a "test set" in the context of human interpretation or AI output 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

Not applicable. This device submission is for a medical device, not an AI/ML algorithm. Therefore, no MRMC study or AI assistance evaluation is mentioned.

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

Not applicable. This device is not an AI/ML algorithm. It is a physical device that delivers nitric oxide.

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

The "ground truth" for the INOmax DS is its adherence to:

• Design Input Specifications: Functional requirements and user needs.
• Design Output Specifications: Detailed engineering specifications.
• Risk Analysis Requirements: Ensuring identified risks are mitigated.
• Applicable Product Standards: Such as IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-1-8, CGA V-1, ASTM F-1462-93, and ASTM F-1054-87.
• FDA Guidance Document for Premarket Notification Submissions: Specifically for Nitric Oxide Delivery Apparatus, NO and NO2 Analyzers (Special Controls).
• Substantial Equivalence: Demonstrated by comparing its specifications and performance to the predicate devices (INOmax DS K061901, INOmax DS K070867, and Datex-Ohmeda INOvent Delivery System K974562).

8. The Sample Size for the Training Set

Not applicable. This device submission does not involve an AI/ML algorithm and therefore has no "training set."

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

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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