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The Ultrasonic Nebulizer is intended to transform liquid medications into aerosol form for patient inhalation. The device can be used by adult or pediatric patients for respiratory treatment in the home, hospital or healthcare environment.

The Ultrasonic Nebulizer is a small, compact, and battery powered potable nebulizer which transforms liquid medicines into aerosol form and delivers directly to patient for inhalation. It makes patient's respiratory treatment easier and more convenient.

Here's an analysis of the K-jump® Ultrasonic Nebulizer based on the provided text, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not contain a specific table of "acceptance criteria" for performance that would typically be found in a detailed validation study. Instead, the document focuses on demonstrating substantial equivalence to a predicate device by comparing technological characteristics and compliance with general safety and performance standards.

However, we can infer some performance characteristics and compliance requirements:

Important Note: The document emphasizes "similar performance" and "compliance with equivalent safety standards" rather than showing specific quantitative performance targets met by the K-jump device and then presenting raw data to prove those targets were met. This is typical for a 510(k) submission where substantial equivalence to a legally marketed predicate device is being demonstrated.

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

The provided document does not specify a sample size for a "test set" in the context of clinical or performance data for this device. The submission relies on demonstrating compliance with recognized standards and similarity in technological characteristics to a predicate device.

• Sample size for test set: Not specified/applicable in this document's context.
• Data Provenance: The document does not describe patient or clinical data that would have a provenance (e.g., country of origin, retrospective/prospective). The data presented for the K-jump device are engineering specifications and compliance declarations.

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

Not applicable. The document does not describe a study involving expert-established ground truth for a test set. This type of submission focuses on engineering specifications and regulatory compliance, not typically on diagnostic accuracy or interpretation by human experts.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of a test set requiring adjudication in this document.

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 device is an ultrasonic nebulizer, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is outside the scope of this submission.

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

Not applicable. This device is a medical apparatus, not an algorithm, so "standalone" algorithm performance is not relevant.

7. The Type of Ground Truth Used

Not applicable. The "ground truth" concept (e.g., pathology, outcomes data) is not relevant for this type of device submission, which focuses on device functionality, safety, and equivalence to a predicate. The "truth" here is established through engineering testing and compliance with recognized standards.

8. The Sample Size for the Training Set

Not applicable. The K-jump Ultrasonic Nebulizer is a physical medical device, not an AI or machine learning algorithm. Therefore, there is no "training set."

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

Not applicable, as there is no training set for this device.

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The ultrasonic mesh nebulizer model NE403 is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize medications for inhalation by the patient. The device may be used by adult patients at home, hospital & sub-acute care settings.

Nebulizer NE403 is a mesh screen ultrasonic nebulizer which was used ultrasonic Vibrating Mesh Technology ( VMT). The device creates aerosols of liquid medication by ejection of droplets from a mesh vibrated at ultrasonic frequencies. As with other mesh screen ultrasonic nebulizers, the mesh is caused to vibrate by fluidic contact with a ultrasonic piezoelectric member that is energized by application of a high frequency alternating voltage. The VMT nebulizer is portable and quiet. This nebulizer is powered by four AA alkaline batteries or a cable connecting to an AC adapter. Nebulizer NE403 consists of several function units: liquid medication containment, liquid nebulization and ejection, nebulized medicine (brume) channel (breathing parts), power supply, operating and display unit. liquid medication is poured into medicinde container, transformed into something like brume, which is inhaled by patient via breathing parts, thus, the intended use of device is achieved.

The provided text describes a 510(k) submission for a medical device, the Nebulizer NE403. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study data with specific acceptance criteria in the format you requested.

Therefore, many of the requested details about acceptance criteria derived from clinical performance studies, such as effect size of AI assistance or ground truth establishment for a training set, are not applicable to this document. The submission explicitly states that no clinical tests were conducted for substantial equivalence.

However, I can extract information related to non-clinical testing and the comparison to the predicate device.

Here's a breakdown of the available information based on your request:

1. A table of acceptance criteria and the reported device performance:

Since no clinical acceptance criteria are provided, and the submission focuses on non-clinical testing and substantial equivalence, the "acceptance criteria" can be inferred as meeting the requirements of the listed voluntary design standards and demonstrating comparable performance to the predicate device in specific non-clinical tests.

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

• Sample Size for Test Set: Not applicable in the context of a clinical test set. Non-clinical tests were performed on the device itself and its components. The document doesn't specify the "sample size" of devices or components tested for each non-clinical criterion.
• Data Provenance: The non-clinical testing was conducted by the manufacturer, Foshan Gaunying Electronics Co.,Ltd., or outsourced as part of their design validation. The context is a regulatory submission for a device manufactured in China. This is retrospective data from internal testing and compliance work.

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

• Not Applicable. No clinical test set requiring expert-established ground truth was part of this 510(k) submission. Non-clinical tests are validated against engineering specifications, standards, and comparison to a predicate device.

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

• Not Applicable. There was no clinical test set or subjective assessment requiring an adjudication method.

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 device is a nebulizer, a physical medical device for drug delivery, not an AI-assisted diagnostic tool.

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

• Not Applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

• For Non-Clinical Tests: The "ground truth" for the non-clinical tests was based on engineering specifications, recognized international and national standards (IEC 60601-1, IEC 60601-1-2, EN 13544-1), and the performance characteristics of the legally marketed predicate device (Omron Micro Air Vibrating Mesh Nebulizer, K062263). For biocompatibility, it was adherence to ISO 10993 standards.

8. The sample size for the training set:

• Not Applicable. There was no "training set" in the context of machine learning or an AI algorithm.

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

• Not Applicable. As above, no training set was involved.

Summary from the document:

The Nebulizer NE403 demonstrates substantial equivalence through non-clinical testing by:

• Meeting design requirements and conforming to voluntary design standards.
• Showing comparable aerosol performance, dose variability, and particle size variability to the predicate device (Omron Micro Air Vibrating Mesh Nebulizer, K062263).
• Demonstrating biocompatibility according to ISO standards for patient-contacting parts.
• Having the same intended use and fundamental technological characteristics as the predicate device.

The study presented here is a 510(k) premarket notification which relies on demonstrating substantial equivalence to a predicate device, not on extensive clinical trials with detailed acceptance criteria for diagnostic performance as would be seen with AI or imaging devices.

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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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The HL100 Ultrasonic Nebulizer System utillizes the state-of-the-art elecctrospray technology that sprays liquid medication in aerosol form and deliveries it directly to the adult and pediatric patients who suffer from asthma, Chronic Obstructive Pulmonary Disease (COPD) such as emphysema and chronic bronchitis, or other respiratory diseases that are characterized by obstruction to air flow for breathing.

The Health and Life Model HL100 is a mesh screen ultrasonic nebulizer that operates in an identical fashion as other mesh screen ultrasonic nebulizers, including the referenced predicate device. The device creates aerosols of liquid medication of droplets from a mesh (aperture plate) vibrated at ultrasonic frequencies. As with other mesh screen ultrasonic nebulizers, the mesh is caused to vibrate by fluidic contact with a ultrasonic piezoelectric member that is energized by application of a high frequency alternating voltage. The HL100 Ultrasonic Nebulizer System consists primarily of a Main Unit and a Medication Chamber. The Main Unit and the Medication Chamber are single patient re-usable. The Main Unit contains all control circuitry and is powered by a cable connecting to a 115 VAC power source with the AC adapter or two AA alkaline batteries. No medication comes into contact with the Main Unit, only the Medication Chamber. The patient interface consists of a mouthpiece or an optional mask. When the device is turned on, the ultrasonic piezoelectric member vibrates, causing the mesh to vibrate. Liquid medication in the reservoir is caused to be aerosolized by the vibrating mesh into the patient interface where the aerosol particles can be inhaled by the patient.

The provided text describes a 510(k) summary for the Health and Life Model HL100 Ultrasonic Nebulizer System. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as it is not an AI/ML device.

The document primarily focuses on establishing substantial equivalence to a predicate device (Omron Model NE-U22V MicroAir Nebulizer K062263) through non-clinical tests.

Here's a breakdown of why an AI/ML framework cannot be applied:

• Device Type: The HL100 is a physical medical device (ultrasonic nebulizer) that mechanically aerosolizes medication. It does not use algorithms, AI, or machine learning for any part of its function or diagnosis.
• Study Type: The submission explicitly states: "Nonclinical tests have been performed comparing the HL100 Ultrasonic Nebulizer System to the predicate device and have shown that the performance of the HL100 Ultrasonic Nebulizer System is substantially equivalent to the performance of the predicate device. No clinical tests were conducted." This means no human subject data was collected or analyzed in the manner required for an AI/ML device study.
• Lack of AI/ML Specific Information: The document contains no mention of:
  • Algorithms, models, or software
  • Performance metrics like sensitivity, specificity, AUC, or accuracy typically used for AI/ML.
  • Training data, test sets, ground truth establishment by experts, or adjudication methods.
  • Multi-reader multi-case (MRMC) studies or standalone algorithm performance.

Therefore, I cannot populate the requested table or answer the specific questions related to AI/ML device studies because the provided document describes a conventional medical device demonstrated to be substantially equivalent via non-clinical performance comparisons, not an AI/ML product.

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