(28 days)
The Aeroneb® Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhulple patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb® Professional Nebulizer System is suitable for use in adult and pediatric patients.
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This document is a 510(k) premarket notification decision letter from the FDA regarding the Aeroneb Professional Nebulizer System. It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, this document does not contain information about acceptance criteria, device performance testing, study design (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance), or training set details typically associated with AI/ML-based medical devices or complex diagnostic systems that require such extensive validation studies.
The Aeroneb Professional Nebulizer System is a medical device (nebulizer) that delivers aerosolized medications. Its substantial equivalence determination is based on manufacturing, performance specifications (likely particle size, delivery rate, durability), and safety related to its intended use, not on complex data-driven diagnostic or interpretative capabilities that would require the kind of clinical validation study described in the prompt.
Therefore, I cannot provide the requested information from the provided text. The document does not describe the type of study that would involve:
- A table of acceptance criteria and reported device performance related to a diagnostic or interpretative function.
- Sample sizes for test sets or training sets in the context of machine learning.
- Ground truth established by experts, adjudication methods, or MRMC studies.
- Standalone algorithm performance.
The submission is for a traditional medical device (nebulizer) where performance is typically assessed through engineering tests, biocompatibility, and perhaps limited clinical trials demonstrating drug delivery effectiveness or safety, but not statistical performance on diagnostic tasks that rely on "ground truth" derived from expert consensus or pathology, as seen in AI/ML validation.
§ 868.5630 Nebulizer.
(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).