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The HOMED Mesh Nebulizer is an ultrasonic vibrating mesh nebulizer system designed to aerosolize physician-prescribed liquid medications for inhalation to a patient except for Pentamidine. The device may be used with patients 5 years and older in the home, hospital, and sub-acute care settings.

The HOMED Mesh Nebulizer is a small, handheld, internally powered general purpose nebulizer which utilizes vibrating mesh technology to generate aerosol.

The document provided outlines the K170886 510(k) premarket notification for the HOMED Mesh Nebulizer, comparing it to a predicate device, the Omron NE-U22 (K062263). The study described focuses on demonstrating substantial equivalence, primarily through non-clinical performance testing related to aerosol particle characterization, rather than human-in-the-loop clinical studies.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the HOMED Mesh Nebulizer are primarily established through comparative testing against a predicate device (Omron NE-U22). The goal is to demonstrate "substantial equivalence" in terms of performance and safety.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the nebulizer's performance are primarily based on demonstrating comparable performance to the predicate device across various aerosol characteristics (MMAD, GSD, different particle doses, total delivered dose) for different medications and flow rates. This is explicitly stated in "Summary of Non-Clinical Performance Testing" and demonstrated by Tables 3 and 4 where the proposed device's performance values consistently fall within or are very similar to the ranges reported for the predicate device, or are directly compared to show "very similar" results.

Study Details:

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

• Sample Size: The document does not specify exact sample sizes for the particle characterization tests (e.g., how many nebulizer units were tested, or how many runs were performed for each medication/flow rate). It presents 95% confidence intervals for the results, implying repeat measurements were taken.
• Data Provenance: The data appears to be from non-clinical laboratory testing ("We performed a number of non-clinical tests") conducted by the manufacturer, Shenzhen Homed Medical Device Co,.Ltd., presumably in China (the manufacturer's location is in Shenzhen, PRC). The data is prospective as it's generated specifically for this premarket submission to demonstrate equivalence.

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

• This information is not applicable in this context. The "ground truth" for nebulizer performance in this 510(k) submission is established by objective physical measurements using standardized cascade impaction techniques and comparison to the predicate device's measured performance. There are no human experts "establishing ground truth" in the way a radiologist might for an AI image analysis system.

4. Adjudication Method for the Test Set:

• This is not applicable. As the "ground truth" is based on objective physical measurements, there is no need for expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, an MRMC study was NOT done. This submission is for a medical device (nebulizer) that delivers medication, not an AI or imaging diagnostic device that involves human interpretation of cases. The study focuses on the physical performance characteristics of the nebulizer, not on improving human reader performance.

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

• This question is partially applicable given the software component ("Software driven - Yes - firmware"). The software verification and validation testing ("Software Verification and Validation Testing") was conducted. The specific performance of the software (firmware) is related to its control of the vibrating mesh module (e.g., maintaining 117 kHz frequency, nebulization rate, power consumption) and LED indicators. While an explicit "standalone performance study" in the context of diagnostic accuracy isn't mentioned, the software V&V and the overall device performance (particle characterization) inherently demonstrate the algorithm's correct function in controlling the nebulization process. The "Level of Concern" for the software is "moderate," indicating that software failure could lead to a delay in appropriate medical care.

7. The Type of Ground Truth Used:

• The ground truth for the device's technical performance (e.g., particle size, delivered dose) is based on objective, standardized laboratory measurements using a cascade impactor, following established protocols (e.g., "Particle Characterization per Cascade Impactor").
• For other aspects like electrical safety and biocompatibility, the ground truth is established by compliance with recognized consensus standards (e.g., IEC 60601-1, ISO 10993-1).

8. The Sample Size for the Training Set:

• This is not applicable. This document describes a 510(k) submission for a physical medical device (nebulizer), not an AI/Machine Learning model that requires a "training set" in the conventional sense. The "firmware" is mentioned, implying some level of software control, but it's not an adaptive learning algorithm.

9. How the Ground Truth for the Training Set was Established:

• This is not applicable for the same reason as point 8. There is no training set for an AI model. For the device's development and manufacturing, the "ground truth" for its design and desired performance would have been established through engineering specifications, previous research, and predicate device analysis.

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