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The Intelligent Mesh Nebulizer designed to aerosolized liquid medications for inhalation by patient, the device may be used with pediatric (>4 years of age) and adult patients in the home, hospital and sub-acute care settings. It is not intended for use with Pentamidine.

The proposed device is a vibrating mesh nebulizer that uses low frequency vibration to create aerosol and delivers 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 device is a portable size, curvaceous body design that is convenient to hold, and ability to detect the amount of medications available. Which is battery powered, 3.7V d.c. internally lithium battery. The medication container capacity is 8ml maximum. The proposed device consists of two parts: physical device and APP software. For physical device, it is pushed by certain circuit frequency vibration to make piezoelectric ceramic vibrate harmony that caused high speed vibration of metal mesh. And the medicine liquid 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. For APP software, it consists of interactive games, Aerosol Flow rate adjustment, power off and information display which could enhance entertainment and users' adherence to the nebulizer during treatment. It could be connected to the physical device by bluetooth. Firstly, when users inhale and exhale, the flow pressure could trigger two single-way switches(inhalation switch and exhalation switch) seprately on atomizing cup, then it could transmit signal to CPU of the device by sensor and the signal will be transmitted to the APP further by bluetooth to control playing interactive games. Secondly, the APP could calculate atomizing time and dosage according to the information transmitted from physical device, and display them in the games. There are 2 models included, NEB001/NEB002, the two models have same intended use, mechanism of action, principle and specification. The only difference between two models is that the model NEB001 has two parts, Physical Device and App software, the NEB001 has the function of Bluetooth for connection between the physical device and App; the model NEB002 only has physical devcie.

The provided text is a 510(k) summary for the "Intelligent Mesh Nebulizer" and primarily focuses on demonstrating substantial equivalence to predicate devices based on non-clinical testing. It does not contain information about a study proving the device meets acceptance criteria related to AI/algorithm performance (e.g., accuracy, sensitivity, specificity, or human reader improvement with AI assistance).

The document specifically states:

• "No clinical study is included in this submission." (Page 8)
• The "Intelligent Mesh Nebulizer" uses an "APP software" that consists of "interactive games, Aerosol Flow rate adjustment, power off and information display which could enhance entertainment and users' adherence to the nebulizer during treatment." And it can be "connected to the physical device by bluetooth." (Page 5). This suggests the software component is more for user engagement and control rather than a diagnostic or analytical AI.
• The tests mentioned are primarily for electrical safety, biocompatibility, electromagnetic compatibility, software validation (general, not necessarily for AI performance), particle size distribution, wireless data integrity, and wireless coexistence.

Therefore, I cannot provide the requested information regarding AI algorithm acceptance criteria or a study proving its performance, as this information is not present in the provided text.

Based on the context of the document, the "acceptance criteria" discussed are related to the device's physical and functional performance as a nebulizer and its compliance with relevant medical device standards, not AI performance.

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