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The INOmax® DSIR Plus delivers INOMAX® (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant on 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 ventilators and respiratory care devices that the INOmax DSIR Plus has been validated with.

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

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

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

The INOmax® DSIR Plus must only be used in accordance with the indications, warnings and precautions described in the nitric oxide drug packaging inserts and is indicated for use in term and near-term (>34weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension. INOmax DSIR Plus is indicated for a maximum of 14 days of use. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and secondary targeted clinical setting is the transport of neonates.

The INOmax DSR® Plus 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.

All revisions of INOmax DSm® Plus utilize component technology to deliver Nitric Oxide gas to the patient. The components consist of the Delivery System unit, the blender, a stand/cart and the NO gas tanks. In this revision of the INOmax DSIR® Plus, the significant changes to the device include the labeling and main circuit board.

The provided text describes a 510(k) premarket notification for the INOmax DSIR® Plus device, which is a nitric oxide administration apparatus. It focuses on demonstrating substantial equivalence to a predicate device (K200389) rather than an AI/ML-based device requiring a study to prove meeting acceptance criteria based on performance metrics like sensitivity, specificity, or AUC.

Therefore, the requested information regarding acceptance criteria, study design for proving device performance, sample sizes for test/training sets, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment (which are typical for AI/ML device evaluations) are not applicable to this submission.

The document explicitly states: "The subject of this premarket submission, INOmax DSm® Plus, did not require clinical studies to support substantial equivalence." This reinforces that the evaluation was based on non-clinical tests demonstrating design changes and continued safety/performance relative to the predicate, not on a clinical performance study with human subjects or AI-based diagnostic/prognostic output.

The "acceptance criteria" for this device, as implied by the submission, are largely related to engineering, safety, and performance as compared to the predicate device, and these were met through non-clinical testing.

Here's a breakdown of the relevant information provided, mapping it to your request where applicable, and noting where information is not present due to the nature of the submission:

Acceptance Criteria and Device Performance (Not Applicable in the AI/ML sense):

Detailed Breakdown per your request:

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

   • As shown in the table above, the "acceptance criteria" are implied by the non-clinical tests performed (e.g., meeting IEC standards, successful risk analysis, verification of functionality). The "reported performance" is that these tests were passed, supporting substantial equivalence. There are no quantitative performance metrics like sensitivity/specificity for a diagnostic AI.

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

   • Not applicable. This was not a data-driven performance study in the context of AI/ML. "Testing" refers to hardware, software, and system verification/validation against engineering specifications and recognized standards, not a clinical test set of patient data.

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):

   • Not applicable. There was no "ground truth" to establish in the context of an AI/ML diagnostic or prognostic system. The device's function is gas delivery and monitoring, not diagnosis.

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

   • Not applicable. No expert review or adjudication process was described or required 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:

   • No. This device is not an AI-assisted diagnostic tool.

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

   • Not applicable. The device itself is a medical apparatus, not an algorithm, and its performance is assessed via engineering and system validation, not standalone algorithmic evaluations.

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

   • Not applicable. No "ground truth" in the AI/ML sense was used. Device functionality and safety were verified against engineering specifications, simulated physiological conditions (e.g., gas flow and concentration measurements), and recognized standards.

8. The sample size for the training set:

   • Not applicable. There was no AI/ML training set.

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

   • Not applicable. There was no AI/ML training set.

In summary, the provided document is a 510(k) summary for a medical device that delivers and monitors nitric oxide. The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing (e.g., electrical safety, performance testing, software verification, biocompatibility), rather than clinical performance studies involving a test set with established ground truth, which would be typical for AI/ML-based diagnostic or prognostic devices.

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

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

The INOmax® DSIR Plus includes a backup NO delivery capability that provides a fixed flow of NO which along with user supplied 10 L/min of oxygen provides 20 ppm in the gas flow to a patients breath. 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 DSR® Plus 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 INOmax® DSIR Plus 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® DSIS Plus provides continuous integrated monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system.

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

The INOmax® DSIR Plus 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.

All revisions of INOmax DSm® Plus utilize component technology to deliver Nitric Oxide gas to the patient. The components consist of the Delivery System unit, the blender, a stand/cart and the NO gas tanks. In this revision of the INOmax DSm® Plus, the only changes to the device includes the labeling for compatibility with respiratory care device.

This document, K200389, is a 510(k) premarket notification for the INOmax DSIR Plus, a nitric oxide administration apparatus. It focuses on demonstrating substantial equivalence to a predicate device (K131686), specifically by adding compatibility with new ventilator and breathing devices.

Based on the provided text, the device performance assessment relies entirely on nonclinical (bench) testing and comparison to a previously cleared predicate device. There is no evidence of clinical studies involving human subjects or AI algorithms in this document. Therefore, many of the requested points regarding AI/MRMC studies, expert ground truth adjudication, and training/test set sample sizes are not applicable to the information presented.

Here's the breakdown of what can be extracted from the document:

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

The document does not provide a specific table of acceptance criteria with corresponding performance metrics like "accuracy > X%". Instead, it refers to a "Ventilator/Gas Delivery System Validation Test Protocol" used for the predicate device (K131686) and states that this same protocol, with "insignificant differences," was used for the INOmax DSIR Plus. The general acceptance criterion implied is that the device "performs within published specifications" and that "the hazards were mitigated" based on this protocol.

• Acceptance Criteria (Implied): Performance according to "published specifications" and mitigation of identified hazards, as demonstrated through the "Ventilator/Gas Delivery System Validation Test Protocol."
• Reported Device Performance: "Ultimately, the requirements necessary for the operation of the INOmax DSIR passed." and "This Bench Testing was conducted across all platforms to demonstrate that the INOmax DSIR® Plus performs within published specifications."

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: Not explicitly stated as a number of patient cases or images. The "test set" in this context refers to the bench testing conducted on the device's compatibility with a list of new ventilator and breathing devices. The document lists 11 specific additional ventilator devices that were tested for compatibility:
  • Covidien PB 980 (K131252)
  • GE Healthcare Carescape R860 (K142679)
  • Fisher & Paykel Healthcare RT330 Breathing Circuit and Optiflow Jr (Class I, 510(k) Exempt under 21 CFR 868.5340)
  • Bunnell Inc Life Pulse 204 (P850064)
  • Drager Perseus A500 (K133886)
  • Fisher & Paykel Healthcare Airvo 2 (K131895)
  • Drager Carina (K072885)
  • Maquet Servo u/n (K151814)
  • Hamilton C3 (K161450)
  • IMT Medical Bellavista (K163127)
  • Maquet Flow-i (K160665)
  • Bio-Med TV-100 (K173973)
  • Phillips V60 (K102985)
• Data Provenance: The data originates from bench testing (laboratory) rather than clinical patient data. Country of origin for the testing is not specified but is presumed to be associated with the manufacturer (Mallinckrodt Manufacturing, LLC, based in Madison, Wisconsin, USA). The testing is prospective in the sense of being conducted specifically for this submission, although it leverages a protocol from a previous clearance.

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)

Not applicable. This device is a hardware apparatus for administering nitric oxide, not an AI algorithm requiring expert human interpretation of medical images or data for ground truth. The "ground truth" for the nonclinical testing would be the engineering specifications and expected performance, verified through the validation protocol.

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

Not applicable, as no human expert adjudication of data (like medical images or clinical outcomes) was performed. The "adjudication" of the bench test results would be whether the device passed or failed the predefined engineering/performance criteria in the validation protocol.

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. This document explicitly states, "The subject of this premarket submission... did not require clinical studies to support substantial equivalence." This means no human-in-the-loop performance study, MRMC study, or AI assistance was involved.

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

No. This device is a physical medical device, not an AI algorithm.

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

The "ground truth" used for this device's validation was engineering specifications and performance criteria established in the "Ventilator/Gas Delivery System Validation Test Protocol," likely determined by design requirements and regulatory standards for medical devices of this type.

8. The sample size for the training set

Not applicable. There is no AI component or training set mentioned in this submission.

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

Not applicable. There is no AI component or training set mentioned in this submission.

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The INOmax DSIR® Plus MRI delivery system is indicated for delivery of INOMAX® (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant on of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. The INOmax DSIR® Plus MRI is indicated for use only with MR Conditional ventilators validated to be compatible, as identified in the device labeling.

The INOmax DSIR® Plus MRI is indicated for continuous integrated monitoring of inspired 02, NO2, and NO.

The INOmax DSIR® Plus MRI is considered MR Conditional with the use of 1.5 Tesla static magnetic field scanners ONLY in areas where the field strength is less than 100 gauss.

The target patient population is controlled by the drug labeling for INOMAX® and is currently neonates. The primary targeted clinical setting is a clinical 1.5 Tesla and 3.0 Tesla diagnostic imaging environment.

The INOmax DSIR® uses a "dual-channel" design to provide 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 specially designed injector module enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose 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 a comprehensive alarm system. The dual-channel approach to delivery and monitoring permits INOMAX® delivery independent of monitoring but also allows the monitoring system to shut down INOMAX® delivery if the monitored NO concentration exceeds 100 ppm for 12 consecutive seconds. The delivery system can also shut down delivery if it detects certain serious problems with the monitoring system.

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

The INOmax DSIR Plus MRI 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 of NO to a patient breathing circuit. The INOblender® can also be used for backup.

The provided document is a 510(k) summary for the INOmax DSIR® Plus MRI, a nitric oxide administration apparatus. It outlines the device description, intended use, technological characteristics, and a comparison to a predicate device, as well as a summary of nonclinical tests performed.

However, the document does not contain the specific information requested about acceptance criteria and a study proving the device meets those criteria in the context of typical AI/ML medical device submission requirements.

Here's why and what information can be extracted or deduced:

This document describes a hardware medical device, not an AI/ML powered software or diagnostic device. Therefore, the concepts of "acceptance criteria" and "device performance" as typically discussed for AI/ML models (e.g., sensitivity, specificity, AUC) are not directly applicable in the same way. The "performance" here refers to the device's functional operation meeting engineering specifications.

Let's address each point based on the available information:

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

• Acceptance Criteria (Deduced from testing goals): The document implies acceptance criteria are related to the device's functional performance:

  • O2 dilution: The device should not unacceptably dilute oxygen concentration.
  • Effect on delivered pressures: The device should not adversely affect ventilator delivered pressures.
  • INOmax DSIR® delivery accuracy: The device should accurately deliver Nitric Oxide.
  • NO2 generation: The device should not generate unacceptable levels of Nitrogen Dioxide.
  • MRI Compatibility: Device classified as MR Conditional for 1.5 Tesla and 3.0 Tesla static magnetic field scanners in areas where field strength is less than 100 gauss (via ASTM standards and other tests).
  • Electrical Safety & EMC: Conformity to IEC 60601-1 and IEC 60601-1-2.
  • Alarm Systems: Conformity to IEC 60601-1-8.
  • Software Functionality: Software version 3.1.2 meets specified requirements.
  • Usability: Meets human factors engineering requirements (ANSI/AAMI HE75).
  • Backup delivery: Provides fixed flow of 250 mL/min of NO.

• Reported Device Performance:

  • "The INOmax DSIR® performed within published specifications when used with each of the ventilators in both primary and backup delivery."
  • "The INOmax DSIR® Plus MRI meets its system level requirements and that the new/modified features function as specified."
  • Compliance with specific FDA recognized consensus standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, ASTM F2052-06, ASTM F2119-07, ASTM F2503-13).

Table of (Deduced) Acceptance Criteria and Performance:

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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.

The provided document describes the INOmax DSIR® (Delivery System), a device for delivering nitric oxide to patients. The submission is a 510(k) for a software update (version 3.0) and compatibility with two additional respiratory care devices (Hamilton C1 and T1 Ventilators).

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

1. Table of Acceptance Criteria and Reported Device Performance

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

The document describes testing for the new software version and compatibility with two new ventilators. The "test set" consisted of:

• Two additional respiratory care devices: Hamilton C1 Ventilator (K120574) and Hamilton T1 Ventilator (K120670).
• INOmax DSIR® settings: Five settings were used: 0 (baseline), 1, 5, 20, 40, and 80 ppm, for each setting and mode of ventilation, as well as the Backup mode.

The data provenance is non-clinical testing, performed in a controlled laboratory setting (likely within the company or a certified testing facility). There is no indication of country of origin of the data, but the company is based in Madison, Wisconsin, USA. The testing is prospective in the sense that it was conducted specifically to support this 510(k) submission.

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

There is no mention of "experts" being used to establish ground truth in the context of the device's technical performance. The "ground truth" for this engineering validation would be the physical measurements taken by calibrated instruments, and the functionality verification against predetermined specifications. The text does not refer to human experts evaluating the "ground truth" of the device's performance characteristics.

4. Adjudication Method for the Test Set

Not applicable. This was a technical performance verification study, not a study involving human interpretation where adjudication would typically be used to resolve discrepancies in expert opinions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "The subject of this premarket submission, INOmax DSix®, with updated software and interfaced to each of the selected respiratory care devices, did not require clinical studies to support substantial equivalence."

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

Yes, this was effectively a standalone performance evaluation of the device. The testing described assesses the device's ability to accurately deliver nitric oxide, monitor gases, and function with specific ventilators, without human intervention being part of the performance measurement itself (though human users operate the system). The tests focused on the device's intrinsic mechanical and software performance.

7. The Type of Ground Truth Used

The ground truth used for the performance testing was instrumental measurements of various parameters (e.g., O2 dilution, delivered pressures, NO delivery accuracy, NO2 generation) and functional verification against predetermined specifications for software features and alarms.

8. The Sample Size for the Training Set

Not applicable. This device is a hardware/software system, not an AI/ML algorithm that requires a "training set" in the conventional sense. The "software update" refers to deterministic code changes and feature enhancements, not a learned model.

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

Not applicable, as there is no "training set" in the context of AI/ML. The "ground truth" for the device's design and functionality would be established through engineering specifications, previous predicate device performance, and compliance with recognized standards.

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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.

Here's an analysis of the provided text regarding the INOmax DSIR device, focusing on acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text describes a compatibility study rather than a traditional performance study with explicit numerical acceptance criteria for accuracy metrics. The study aims to demonstrate substantial equivalence by confirming compatibility with additional respiratory care devices. Therefore, the "acceptance criteria" are implied to be the device performing within its published specifications and meeting the four necessary requirements for compatibility.

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

• Sample Size: The text states, "Five INOmax DSIR® settings were used [0 (baseline), 1, 5, 20, 40, and 80 ppm] for each setting and mode of ventilation, as well as the Backup mode." It also mentions "both devices were set up and calibrated... and tested using the settings established for each respiratory care device test." The "new respiratory care devices" are the Drager Apollo Anesthesia Ventilator and the CareFusion ReVel Ventilator.
  • This implies testing across different modes of ventilation (which are not specifically enumerated, but would be several for each ventilator) and these 6 concentrations for each mode, for both primary and backup delivery, across two different new ventilators.
  • While specific case numbers aren't given in a medical imaging sense, the "sample size" here refers to the extensive set of configurations and parameters tested: 2 ventilators * (multiple modes) * 6 NO concentrations * 2 delivery types (primary/backup).
• Data Provenance: The study is nonclinical (laboratory testing) and was conducted by the submitter (INO Therapeutics doing business as Ikaria). The country of origin is not explicitly stated but can be inferred to be the USA, where the company is based and where the 510(k) submission was made. The study is prospective as it involves active testing of the device under specific conditions.

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

This type of nonclinical, engineering-focused study does not typically involve human experts establishing "ground truth" in the way a clinical diagnostic study would. The "ground truth" in this context is the objectively measured performance of the device against its own published specifications and the expected behavior of the ventilators. The measurements would be taken by trained technicians or engineers following established protocols. No information is provided about expert qualifications or numbers beyond "manufacturer's recommendations" for setup and calibration.

4. Adjudication Method (for the test set)

No formal adjudication method (like 2+1 or 3+1 consensus) is described, as this is not a study involving human interpretation of clinical data. The "adjudication" is based on objective measurements and comparison against established specifications. "Any anomalies found" were recorded, implying a review of results by the testing personnel.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is a nonclinical, engineering compatibility test, not a clinical study involving human readers or cases.

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

Yes, this was a standalone performance study in the sense that it evaluated the performance of the device (INOmax DSIR®) itself when interfaced with two specific ventilators. There was no human-in-the-loop component being evaluated for its diagnostic or therapeutic effectiveness; rather, the device's ability to maintain its intended performance characteristics in a new configuration was assessed.

7. The Type of Ground Truth Used

The ground truth used was objective performance measurements of the INOmax DSIR® against its published specifications and the expected operational parameters of the ventilators (e.g., delivered oxygen concentration, pressure, NO concentration, NO2 generation).

8. The Sample Size for the Training Set

No training set is mentioned or applicable. This is a conformance and compatibility test, not a machine learning study.

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 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 text describes the INOmax DS delivery system and its acceptance criteria, primarily focusing on its compatibility with the Vapotherm Precision Flow system. It does not contain information about a study proving the device meets the acceptance criteria in the typical sense of a clinical statistical study for AI/machine learning devices. Instead, it describes non-clinical engineering tests.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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