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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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