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The Ultrasonic Mesh Nebulizer designed to aerosolized liquid medications for inhalation by patient, the device may be used with pediatic (>4 years of age), defined by the prescribed medication, and adult patients in the home, hospital and sub-acute care settings.

It is not intended for use with Pentamidine.

The proposed devices are vibrating mesh nebulizers that use low frequency vibration to create aerosol and deliver aerosolized medication to the lower respiratory tract by using a vibrating mesh to create aerosol and provide fine particles to the patient's lungs. The mesh plate has holes to create low velocity aerosol.

The proposed devices are portable size, curvaceous body design that is convenient to hold, Which are battery powered, 3.7V d.c. internally lithium battery. The medication container capacity is 8ml maximum.

For devices, they are pushed by certain circuit frequency vibration to make piezoelectric ceramic vibrate harmony that caused high speed vibration of metal mesh. And the medicine liguid will be quickly popped through micro mesh hole of metal mesh plate to be countless micro atomizing particles. This will be further transferred by inhalation treatment using masks or mouthpieces to patients' respiratory system.

There are 3 models included, MY-123/MY-125/ the three models have same intended use, mechanism of action, principle and specification. The difference between three models is appearance.

The provided text describes a 510(k) premarket notification for an Ultrasonic Mesh Nebulizer (K201397). This submission focuses on demonstrating substantial equivalence to a predicate device (Intelligent Mesh Nebulizer, K171549) rather than proving the device meets acceptance criteria through a traditional clinical study with defined performance metrics for an AI/CAD/imaging device.

Therefore, the requested information regarding acceptance criteria, study design for proving device performance, sample sizes, expert involvement for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable in the context of this 510(k) submission.

The document primarily provides a comparison of the proposed device's characteristics and performance to a predicate device to demonstrate substantial equivalence. The "acceptance criteria" here are implicitly that the new device performs "as well as" the predicate device in terms of aerosol delivery characteristics and various safety tests.

Here's how the provided information aligns with your request, highlighting the differences:

1. Table of Acceptance Criteria and Reported Device Performance

Instead of clearly defined acceptance criteria with pass/fail thresholds for clinical performance (as would be typical for an AI/CAD device), the document presents a comparative table showing the performance characteristics of the Subject Device (Ultrasonic Mesh Nebulizer) against the Predicate Device (Intelligent Mesh Nebulizer).

The "acceptance" in this context is based on the new device being sufficiently similar to and performing comparably to the legally marketed predicate device across various parameters.

Conclusion from document: "The proposed devices are substantially equivalent to the predicate device. Based on the nonclinical tests performed, the subject devices are as safe, as effective, and performs as well as the legally marketed predicate device."

The remaining points are largely not applicable because this is a medical device substantial equivalence submission (510k) for a nebulizer, not a software/AI device that requires extensive clinical validation of diagnostic performance.

2. Sample sized used for the test set and the data provenance:

• This document refers to "nonclinical tests" (biocompatibility, electrical safety, EMC, software V&V, shelf life, cleaning/disinfection, human factors, particle size distribution). These are lab-based tests, not clinical test sets with patient data.
• The "particle test comparison" table presents data from performance testing, likely derived from multiple runs/measurements for each nebulizer model and drug type. Specific "sample sizes" in terms of patients or independent cases are not relevant here.
• Data provenance (country, retrospective/prospective) is not mentioned as this is not a clinical data study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. There is no "ground truth" derived from expert consensus on medical images or clinical outcomes in this submission. The "ground truth" for the nonclinical tests would be defined by the testing standards and procedures themselves.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. No expert adjudication process for a test set is described.

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:

• Not applicable. This is not an AI-assisted diagnostic device, so MRMC studies are not relevant.

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

• Not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not applicable in the AI/CAD sense. The "ground truth" for proving substantial equivalence of a nebulizer involves demonstrating compliance with recognized standards (e.g., ISO, IEC for safety, electrical, biocompatibility) and comparable physical/performance characteristics (e.g., particle size distribution, nebulization rate) to a predicate device.

8. The sample size for the training set:

• Not applicable. This device does not use a "training set" in the context of machine learning.

9. How the ground truth for the training set was established:

• Not applicable. (See #8)

Summary of what was done:

The manufacturer performed a series of non-clinical bench tests to demonstrate that their Ultrasonic Mesh Nebulizer (MY-123, MY-125, MY-126) is substantially equivalent to a legally marketed predicate device (Intelligent Mesh Nebulizer, K171549). These tests included:

• Biocompatibility testing
• Electrical Safety and Electromagnetic Compatibility (EMC) testing
• Software Verification and Validation Testing (for the device's embedded software, categorized as "moderate" level of concern)
• Simulated shelf life testing
• Battery cycle life testing
• Cleaning and Disinfection Validation
• Human factors validation testing
• Particle size distribution testing (using Salbutamol, Budesonide, and Ipratropium bromide, per FDA guidance for nebulizers). This is the primary "performance" test described, showing comparable MMAD, GSD, and particle fractions to the predicate.

The conclusion is based on a side-by-side comparison of these test results and technological characteristics with the predicate device, showing "no new issues of safety" and that the subject devices perform "as well as" the predicate. No clinical study was included in this submission.

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