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A hand-held nebulizer to aerosolize commonly prescribed liquid drugs (except pentamadine) for inhalation by patients in the Home, Hospital and Nursing Home settings - anywhere aerosolized drug delivery is utilized.

The Inspired Medical Products Sidestream Nebulizer is identical to the Medic-Aid Sidestream Nebulizer cleared under K924123.
Made of three components - top, baffle, base.
Materials in contact with patient - polypropylene.
Provided clean, non-sterile.

The provided text is a 510(k) premarket notification for a medical device called the "Sidestream Drug Nebulizer." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with defined acceptance criteria and performance studies in the way an AI/ML device might.

Therefore, the document does not contain information about acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML device. Specifically:

• It does not mention a test set, training set, ground truth, expert consensus, MRMC studies, or standalone performance results.
• It does not involve detailed performance metrics like sensitivity, specificity, or accuracy that would be associated with AI/ML diagnostic tools.

Instead, the document's purpose is to demonstrate that the new "Sidestream Drug Nebulizer" is substantially equivalent to existing predicate devices (Medic-Aid Sidestream Nebulizers K924123 and K914152B) based on comparable intended use, environment of use, patient population, design, materials, and performance standards. The key finding is stated as: "There are no differences in performance, safety, or efficacy between the intended device and the predicates."

If this were an AI/ML device, the acceptance criteria and study information would be crucial. However, for this traditional medical device submission, the "study" is a comparison to predicates, and the "acceptance criteria" are satisfied by demonstrating this substantial equivalence.

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