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K-jump Health Co., Ltd. Ultrasonic Nebulizer System includes a DC powered ceramic resonator and a fan that provides a source of mist for home health care use. The device is used with a pneumatic nebulizer to convert certain inhaled drugs into an aerosol form for inhalation by a patient. The device can be used with adult or pediatric patients.

The KN-9210 uses the ultrasound vibration technique in which a piezeoelectric ceramic installed as a generator of ultrasound wave when powered key pressed and system been powered on. The medicine solution on the semi-oval cup can be converted to mist through the water medium which propagated the ultrasound from resonator on the device. Then, a mini fan on the device drives the mist or aerosol through the air flow chamber and mouth piece installed on the top cover to the patient. The patient can use this aerosol for his/her respiratory therapy with two-safety valve installed on the mouthpiece which is standed on the top of drug ampoule.

The device consists of a piezeoelectric ceramic, a fan, a plastic body (including a top cover, a main body, a rear cover, an inlet filter, a filter cover, a nebulization chamber and an air-flow chamber), a medicine cup, a printed circuit board with electronic components, a DC socket, an AC adapter power source (or a rechargeable battery assembly as an optional power source), and a key for ON/OFF operation.

The provided submission is for an Ultrasonic Nebulizer System (Model KN-9210), which is a medical device and not an AI/ML software device. Therefore, the requested information regarding acceptance criteria and studies proving the device meets them, especially those related to AI/ML performance, is not directly applicable in the typical sense for this document.

However, based on the provided text, I can extract and infer information relevant to the device's performance characteristics and the non-clinical tests conducted to demonstrate substantial equivalence to predicate devices.

Here's a breakdown of the available information, adapted to the requested structure where possible, but noting the absence of AI-specific details:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a nebulizer, the acceptance criteria relate to its physical performance in delivering medication. The "reported device performance" are the results of the performance testing conducted.

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

• Sample Size for performance tests: Not explicitly stated. The document mentions tests were conducted on "three medicines" (Atrovent, Bricanyl, Pulmicort), implying at least three distinct test cases for the nebulization performance metrics. For biocompatibility and other engineering tests, typical sample sizes are generally smaller and defined by applicable standards.
• Data Provenance: Not explicitly stated, but the testing would have been conducted by or for K-jump Health Co., Ltd., likely in Taiwan (country of origin of the company). The studies are non-clinical, bench-top performance tests, making them prospective in the sense that they were specifically designed and executed to evaluate the device.

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

• This device is a mechanical/electronic medical device (nebulizer), not an AI/ML diagnostic tool requiring expert interpretation for "ground truth." The performance metrics (e.g., particle size, flow rates) are measured objectively by laboratory instruments and protocols, rather than through expert consensus.
• Hence, this criterion is Not Applicable in the context of this device and submission.

4. Adjudication Method for the Test Set

• Again, this criterion is Not Applicable for a hardware device like a nebulizer. Adjudication methods like 2+1 or 3+1 are used in studies where human readers review and provide consensus on findings (e.g., medical images for AI ground truth).

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 is Not Applicable. An MRMC study is relevant for AI/ML diagnostic tools that assist human readers. The K-jump Ultrasonic Nebulizer System is a therapeutic device that delivers medication; it does not involve human readers interpreting a "case" in the diagnostic sense.

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

• This is Not Applicable. This concept applies to AI/ML algorithms, not a physical medical device like a nebulizer.

7. The Type of Ground Truth Used

• For the performance testing, the "ground truth" would be established by objective measurements from calibrated laboratory equipment according to recognized standards (e.g., for particle size distribution, flow rates).
• For biocompatibility, the "ground truth" is determined by standardized laboratory tests for cytotoxicity, irritation, and sensitization, with results compared against pass/fail criteria from relevant international standards (e.g., ISO 10993).
• For EMC, Electrical, Mechanical, and Environmental Testing, the "ground truth" is compliance with relevant national and international safety and performance standards.

8. The Sample Size for the Training Set

• This is Not Applicable. As a physical medical device, there is no "training set" in the AI/ML sense. Design and development would follow engineering principles, not machine learning training.

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

• This is Not Applicable for the same reason as point 8.

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