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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.

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