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The NE-C801 Nebulizer Compressor System is intended to provide air to the pneumatic nebulizer in order to aerosolize medications for inhalation by the patient for respiratory disorders. The system is designed for use with pediatric (defined by the prescribed medication) and adult patients in the home, hospital, and sub-acute settings.

The Omron NE-C801 nebulizer compressor system is a standard nebulizer compressor system with an integral compressor and handheld, pneumatic nebulizer intended for general purpose use. It is powered by standard AC. This is a modification of the NE-C28 cleared under K060811.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Omron NE-C801 Nebulizer Compressor system:

It's crucial to understand that this document describes a 510(k) Pre-Market Notification for a modified device, the NE-C801, which is being compared to a predicate device, the NE-C28 (cleared under K060811). The primary goal of a 510(k) is to demonstrate substantial equivalence to a predicate device, not necessarily to independently prove de novo safety and effectiveness through extensive clinical trials.

The provided text therefore focuses on demonstrating that the modifications (minor design changes to the nebulizer, and making the compressor smaller and lighter) do not alter the fundamental safety or effectiveness parameters compared to the predicate. No clinical investigation was deemed necessary.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as a set of specific numerical thresholds the new device must meet to be considered successful. Instead, the performance testing aims to demonstrate equivalence to the predicate device within a 95% confidence interval. The "acceptance criteria" implicitly are that the performance of the NE-C801 is comparable to the NE-C28.

4. Adjudication Method for the Test Set

N/A. As the ground truth is based on physical scientific measurements, no human adjudication method was employed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is a physical performance comparability study of a medical device, not a study involving human readers or AI in a diagnostic context. Therefore, an MRMC study and effect size of human reader improvement with AI assistance are not applicable.

6. Standalone Performance Study (Algorithm Only)

Yes, in the context of device performance. The "performance testing" described in the document is a standalone evaluation of the NE-C801's ability to aerosolize medications and deliver particles of specific characteristics, without human intervention as part of the primary function being tested. It's an "algorithm only" equivalent in that it measures the device's intrinsic output.

7. Type of Ground Truth Used

The ground truth used is based on physical measurements and analytical chemistry/physics of the aerosolized medications. Specifically, it involves:

• Particle Characterization per Cascade Impactor
• Total Delivered Dose (ug)
• Total Delivered Dose fraction (%)
• Particle size (Mass Median Aerodynamic Diameter - MMAD) (Microns)
• Geometric Standard Deviation (GSD)
• Respirable Fraction (% Mass 0.5-5 microns)
• Total Respirable Dose (ug 0.5 -5.0 microns)
• Medication captured on USP Throat (ug and fraction %)
• Medication Retained in Device (ug and fraction %)
• Coarse Particle Fraction (%), Fine Particle Fraction (%), Ultra Fine Particle Fraction (%)
• Nebulization rate (g/ml)

8. Sample Size for the Training Set

N/A. This is not an AI/Machine Learning study. There is no concept of a "training set" in this context. The testing involved direct physical measurement of device performance.

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

N/A. As above, there is no training set for this type of device performance study.

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