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The disposable nebulizer set is used to administer various aerosol treatments to adult patients in hospital environments. It is not intended for transport use. The Disposable Nebulizer Set is for less than 24 hours cumulative use.

The disposal nebulizer set is used to administer various aerosol treatments to adult patients in hospital environments. It is not intended for transport use. It is intended for adult patients consistent with the indications for the aerosol medication The Disposable Nebulizer Set is for single use for less than 24 hours cumulative use

The disposal nebulizer set is designed and manufactured by SUZHOU WEIKANG MEDICAL APPARATUS CO., LTD. The disposal nebulizer sets are made of PVC; they are supplied as sterile. It is for single use for less than 24 hours cumulative use. The nebulizer set consists of a hollow tube connected to a nebulizer jar/bottle, which holds the liquid medication; a compressed gas source respiratory size aerosolized liquids into gasses that are delivered directly to the patient for breathing.

The Weikang Disposable Nebulizer Set is a light weight portable aerosol Nebulizer which uses a compressor that causes compressed air to flow at high velocity through a liquid medicine to turn it into an aerosol which is inhaled by the patient.

This FDA 510(k) summary describes the Suzhou Weikang Medical Apparatus Co., Ltd Disposable Nebulizer Set (K140237). It is a premarket notification for a medical device, which means the device is being compared to existing legally marketed predicate devices to show "substantial equivalence."

Based on the provided document, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document establishes substantial equivalence by comparing the proposed device's performance attributes to two predicate devices: Headstar Medical Small Volume Jet Nebulizer (K121770) and Miller (VixOne) (K926055). The acceptance criteria are implicit in the performance characteristics of the predicate devices. The proposed device aims to meet or be comparable to these established performance levels.

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

The document does not explicitly state a "test set" in the context of an AI/algorithm study. Instead, the "testing" involves a series of non-clinical studies (performance bench testing and biocompatibility testing) to demonstrate that the new device has "similar performance characteristics and technological characteristics" to the predicate devices.

• Sample Size for performance testing (Total Dose, Particle Size, Respirable Dose): Not explicitly stated in terms of number of runs or units tested, but numerical results with standard deviations are provided, implying multiple measurements were taken for each parameter.
• Data Provenance: The data appears to be prospective in the sense that it was generated by Suzhou Weikang Medical Apparatus Co., Ltd specifically for this 510(k) submission, comparing their new device's performance to the predicate devices. The country of origin for the testing itself is not explicitly stated, but the manufacturer is based in China.

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

This is not applicable to this document. The device is a medical apparatus (a nebulizer), not an AI algorithm. Therefore, there's no "ground truth" established by experts in the context of diagnostic interpretation or AI model validation. The ground truth for performance measures (e.g., total dose, particle size) is physical measurement against established laboratory standards.

4. Adjudication method for the test set:

This is not applicable as there is no diagnostic image/data interpretation by experts that would require 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:

This is not applicable. The device is a nebulizer, a physical medical apparatus, not an AI-powered diagnostic tool requiring human-in-the-loop performance studies.

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

This is not applicable as the device is not an algorithm.

7. The type of ground truth used:

For the performance characteristics (e.g., total dose, particle size, respirable dose), the "ground truth" is established through physical measurements and adherence to recognized scientific and engineering principles for nebulizer performance testing. For biocompatibility and sterilization, the ground truth is established by compliance with international standards (ISO 10993 series and ISO 11135-1).

8. The sample size for the training set:

This is not applicable. There is no AI/machine learning model, and thus no "training set."

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

This is not applicable as there is no AI/machine learning model.

Summary of the Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria is a series of non-clinical bench tests and compliance assessments described under "Summary of Non-Clinical studies". These studies evaluate the physical and material characteristics of the Suzhou Weikang Disposable Nebulizer Set.

• Biocompatibility: The device was tested for biocompatibility according to ISO 10993-5 (In vitro cytotoxicity) and ISO 10993-10 (Irritation and skin sensitization), and also complies generally with ISO 10993-1.
• Sterilization: The sterilization process (Ethylene Oxide) complies with ISO 11135-1, and residual ethylene oxide levels comply with ISO 10993-7.
• Performance Testing: The device's performance characteristics, such as total dose delivered, particle size (MMAD), geometric standard deviation, and total respirable dose for specific medications (Albuterol sulfate, Ipratropium bromide, Cromolyn sodium), were measured and compared to the values reported for the predicate device (Miller/VixOne K926055). The results showed comparable performance, demonstrating substantial equivalence in key therapeutic delivery metrics.
• Other characteristics: Manufacturing materials, intended use, mechanism, target population, anatomic site, environment of use, flow rate, and air pressure were also compared to the predicate devices and found to be sufficiently similar or equivalent.

The conclusion is that based on these non-clinical studies and comparisons, the proposed device is "Substantially Equivalent" (SE) to the legally marketed predicate devices, implying it is as safe and effective. No clinical studies were required to support this claim of substantial equivalence.

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Disposable tracheal tube is intended for oral or nasal intubation and for airway management.

The tracheal tubes are disposable and are supplied sterile. The tracheal tubes are available in a number of sizes/variants. All variants are primarily made from polyvinyl chloride. The tracheal tube without cuff is composed of a tubular body and a standard connector, and the cuffed tube is composed of tubular body, cuff, oneway valve, pilot balloon, inflating tube and standard connector. All variants have a Murphy eye. As the device functions in airway management/gas transport for anesthesia or resuscitation, it is required to be flexible and resistant to kinking. All variants have a radio-opaque line embedded into the tube which enables identification the device when the patient is X-rayed.

This document is a 510(k) Premarket Notification Submission for a Disposable Tracheal Tube. It outlines the device's indications for use, comparison to predicate devices, and performance data to support its substantial equivalence. The document is a regulatory submission filing and not a study report. Therefore, much of the requested information, such as sample sizes for test sets, data provenance, expert qualifications for ground truth, and details about clinical or comparative effectiveness studies, is either not applicable or not provided in the scope of this regulatory submission.

Here's a breakdown of the information that can be extracted and how it relates to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified. The document only states that "testing results demonstrate that the proposed devices meet the requirements of the standards listed above" for performance and biocompatibility. This refers to laboratory testing, not a clinical test set with human subjects for performance evaluation.
• Data Provenance: The device manufacturer, Suzhou Weikang Medical Apparatus Co., Ltd., is located in China. The testing would have been conducted by or for this manufacturer, likely in China or by accredited labs. The document does not specify the country of origin of the raw test data but implicitly it originates from the manufacturer's testing efforts. The testing is for premarket notification, implying developmental/verification testing, not necessarily a "retrospective or prospective" study in the clinical sense.

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

• Not Applicable. For a medical device like a tracheal tube, "ground truth" is established by adherence to recognized international standards and bench testing protocols as specified (e.g., ISO 5361, ISO 11990-1, ISO 10993). There isn't a "ground truth" established by experts in the context of diagnostic accuracy, but rather by objective physical and biological tests.

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

• Not Applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for diagnostic devices where human interpretation is involved and consensus is needed for a "ground truth" label. For physical device performance and biocompatibility testing, the results are objectively measured against predefined standard criteria.

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 disposable tracheal tube, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is entirely irrelevant to this product.

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

• Not Applicable. As stated above, this is not an AI algorithm but a physical medical device. No standalone algorithm performance was evaluated.

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

• Performance Standards and Biocompatibility Test Results: For this device, the "ground truth" is defined by the requirements outlined in international standards (ISO 5361:2012, ISO 11990-1:2011) for physical performance, and the results of specific biocompatibility tests (Cytotoxicity, Sensitization, Irritation) conducted according to ISO 10993-1. These are objective, measurable criteria, not subjective expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

• Not Applicable. This is a physical medical device, not an AI model that requires a training set.

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

• Not Applicable. As no training set is relevant for this device, no ground truth needed to be established for it.

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