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The NeoPAP System is intended to provide continuous positive airway pressure (CPAP) for use in hospitals to treat newborns and infants, weighing less than 5 kg, with RDS or who are recovering from RDS. (Respiratory Distress Syndrome).

The Children's Medical Ventures LLC NeoPAP System provides nasal CPAP (continuous positive airway pressure) as a non-invasive method of breathing support for infants and newborns with compromised respiratory systems who weigh less than 5 kg.

The NeoPAP System provides CPAP therapy delivered to patient through a nasal cannula or mask. The system has a feature called Baby-Trak which actively regulates pressure at all times by monitoring pressure at patient's nose and adjusting flow from oxygen and air gas supplies using proportional solenoids. The Baby-Trak feature eliminates the need for a closely-fitted patient interface that can damage fragile tissues.

In addition to CPAP mode, the NeoPAP System offers a constant flow mode where the device delivers a fixed flow of humidified air/oxygen mixture through the nasal prongs or mask. There is also a resuscitation mode where the device delivers a fixed flow of unhumidified air/oxygen through the resuscitation port for use with a resuscitation or hyperinflation bag. The percentage of oxygen can be adjusted while in any mode by using a rotary knob on the user interface.

The NeoPAP System alarms when pressure levels or oxygen concentration are above or below alarm limits. The system also detects occlusion, disconnect, and other alarm conditions. The system displays a real-time bar graph that indicates delivered pressure.

The provided document describes the NeoPAP System, a medical device for providing continuous positive airway pressure (CPAP) to newborns and infants. It focuses on demonstrating substantial equivalence to a predicate device (Guardian Neonate CPAP / Humidification System, K040862) after modifications.

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

1. Table of Acceptance Criteria and Reported Device Performance

The submission states that "All tests that were created for the modified NeoPAP System had passing results with acceptance criteria successfully met, which demonstrates the safety & effectiveness of the system." However, the specific quantitative acceptance criteria and detailed performance results for each test are not explicitly listed in the provided text. The document primarily focuses on what was tested and the conclusion that criteria were met, rather than presenting the criteria and performance data in a tabular format.

A general summary of some "performance aspects" that are implied to meet criteria through comparison to the predicate device would be:

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

The document mentions "Design verification tests," "Formal test protocols," "bench verification testing," "clinical simulation (usability testing)." However, it does not provide specific sample sizes for any of these test sets. It also does not specify the data provenance (e.g., country of origin, retrospective/prospective) for any of the testing conducted. The "clinical simulation" implies prospective testing, but details are absent.

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

The document mentions "clinical simulation (usability testing confirmed that the NeoPAP System performs equivalently to the predicate device (Guardian Neonate CPAP / Humidification System, K040862))." However, it does not specify the number of experts involved in this usability testing or their qualifications. It also doesn't explicitly state that they established the "ground truth" in a formal sense, but rather that they confirmed equivalence.

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

The document does not specify any adjudication method used for the test set.

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 section is not applicable as the NeoPAP System is a medical device (CPAP system) and not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance was not performed.

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

This section is not applicable as the NeoPAP System is a physical medical device (CPAP system) with embedded software, not a standalone algorithm. The "algorithm" (software) functions as part of the overall device. The software was tested through "software code reviews, software unit testing, software integration testing," which represent standalone testing of the software components.

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

The concept of "ground truth" as typically defined for AI/diagnostic studies (e.g., pathology for disease diagnosis) is not directly applicable here. The "truth" for this device's performance is established by:

• Engineering specifications and standards conformance: For safety, electrical, mechanical, environmental, and biocompatibility aspects.
• Functional performance testing: Verifying that the device operates as intended (e.g., delivers correct pressure, flow, O2 concentration, alarms correctly).
• Equivalence to predicate: The "ground truth" for the modified device's effectiveness appears to be its performance being equivalent to the legally marketed predicate device (K040862) through "clinical simulation (usability testing)."

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or AI. This is a medical device submission focused on verification and validation of a hardware and software system, not a data-driven AI model that requires training data.

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

As there is no mention of a "training set" for an AI model, this question is not applicable.

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