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The Side Draft Neb-U-Mist Nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. This device is for single patient use and is not intended for reprocessing.

The Hudson RCI Side Draft Neb-U-Mist® Nebulizer is a non-sterile, single patient use. Disposable Small Volume Nebulizer device designed to be used for intermittent aerosol therapy to deliver hydrating agents or other prescribed inclutions for inhalation. The Hudson RCI Side Draft Neb-U-Mist® Nebulizers intended to treat bronchial spasms, or airway obstruction, associated with diseases such as asthma, chronic bronchitis, and emphysema.

The Hudson RCI Side Draft Neb-U-Mist® Nebulizer employs the Bernoulli Effect in order to transform the solution of liquid medication into tiny particles that can in order to transform the belation on the Bernoulli Effect - the phenomenon be carried in a gad mixture to with increased stream velocity in a fluid – causes the lowering of lateral pressure around the stream of gas to draw liquid up a the lowering of lateral peaches the top of the capillary tube it comes into contact with the stream of gas, it is then shattered into small particles (approximately 3 to 5 microns). These particles are then forced against a baffle (approximately o to o microne) of the particles that will be delivered to the patient that rouses the larger particles. The larger particles settle inside the Nebulizer by removing the largor particles, returning mist to liquid to repeat nebulization process. The smaller particles are then administered as the patient inhales.

The document provided describes a 510(k) submission for the "Side Draft Neb-U-Mist Nebulizer" and its substantial equivalence to a predicate device. This type of submission focuses on comparing a new device to an already legally marketed device (predicate device) and demonstrating that it is as safe and effective. It does not typically involve a clinical study in the same way a pre-market approval (PMA) application would for a novel device.

Here's an analysis of the provided text in relation to your request:

Acceptance Criteria and Reported Device Performance

The core acceptance criterion for substantial equivalence in this context is that the new device performs similarly to the predicate device, particularly in critical functions. For a nebulizer, this primarily concerns particle size generation and residual volume.

Study Details

Given this is a 510(k) submission based on substantial equivalence to a predicate device, the "study" is primarily a bench-top comparative test, not a clinical trial with human subjects.

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

   • Sample Size: The document does not specify the exact number of nebulizers tested for particle size and residual volume. It broadly states "Particle Size testing... was performed on both devices" and "Residual testing for both the predicate and proposed devices demonstrated...". Typically, such tests involve multiple units of each device for statistical robustness, but the specific number isn't mentioned.
   • Data Provenance: The tests were conducted internally by Hudson Respiratory Care, Inc. The data is retrospective in the sense that it's a comparison to an existing device, but the tests themselves were likely performed prospectively for the purpose of this 510(k) submission. No country of origin for data is stated, but the company is based in California, USA.

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

   • Not applicable. For technological characteristics like particle size and residual volume, the "ground truth" is established through objective measurement methods using laboratory equipment (e.g., laser diffraction for particle size, gravimetric analysis for residual volume). It does not involve expert consensus in the same way clinical image interpretation or diagnosis would.

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

   • Not applicable. Adjudication methods like 2+1 are used for subjective interpretations (e.g., evaluating medical images) where human experts might disagree. Bench-top performance tests are objective and quantitative; data is analyzed statistically, not adjudicated by experts.

4. 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:

   • No, an MRMC study was not done. This is a mechanical device (nebulizer) and the submission focuses on its physical performance characteristics, not on diagnostic accuracy involving human readers or AI assistance.

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

   • Not applicable. There is no "algorithm" in this context. This is a medical device, not a software or AI product.

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

   • Objective Measurement Data. The "ground truth" for the performance characteristics (particle size, residual volume) is derived from direct, quantitative measurements obtained in a laboratory setting using standardized testing protocols.

7. The sample size for the training set:

   • Not applicable. There is no "training set" in the context of an AI/ML model for this device. The development and testing are based on engineering design and bench-top performance evaluation.

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

   • Not applicable. As there is no training set or AI/ML component, this question does not apply.

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