(235 days)
The ILI nebulizer is used to administer various aerosol treatments to adult and pediatric patients in both the homecare and healthcare settings. Its use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a Small Volume Nebulizer is disposable, single-patient-use and intended for use with pediatric (5 years and older) and adult patient.
The JLI nebulizer is a small volume jet nebulizer designed to deliver aerosolized medications for inhalation to the respiratory system, the compressed air is forced into the nebulizer through a nozzle cover, where it accelerates and emerges at a high velocity, creating a vacuum (Venturi effect), in the process the liquid medicine is converted into small droplets called aerosol by impacting upon a rigid baffle, the aerosol may be used for inhalation treatment of a physician's prescription. The JLI nebulizer is disposable, single-patient-use.
The provided text describes the 510(k) premarket notification for the JLI nebulizer, asserting its substantial equivalence to a predicate device (BESMED Jet Nebulizer Bottle Set). However, it does not contain information about an AI/ML-driven medical device. The document details the non-clinical performance and biocompatibility testing of a nebulizer, a hardware device used to administer aerosol treatments.
Therefore, I cannot extract the requested information about acceptance criteria, study design, ground truth establishment, or expert involvement as these details are specific to the evaluation of AI/ML software performance, not hardware nebulizers.
The document discusses:
- Acceptance Criteria for the Nebulizer: This is implied through the comparison of aerosol particle characteristics (MMAD, GSD, Respirable fraction, Total dose) between the JLI nebulizer and the predicate device. The goal is to show "not significant statistical difference" and "substantial equivalence."
- Performance Study: Non-clinical tests were conducted for aerosol characterization using three drugs (Albuterol sulfate, Ipratropium bromide, Budesonide) at two sampling rates (28 L/min and 12 L/min).
- Sample Size for Test Set: For aerosol characterization, the data shows means and standard deviations, implying multiple runs for each drug and sampling rate. For example, for Albuterol sulfate at 28 L/min, the data
7.4990±0.5384indicates a sample size was used to calculate the mean and standard deviation. While the exact number of runs isn't explicitly stated as "N=X", it's implied that there were sufficient runs to provide statistical averages. - Data Provenance: The tests were non-clinical, likely performed in a lab setting by the manufacturer or a contracted lab. The document does not specify country of origin for the performance data beyond the manufacturer being in China. It is explicitly stated that "Substantial equivalence does not depend on clinical test data," meaning no patient data was used.
- Ground Truth: For aerosol characterization, the 'ground truth' is the quantitative measurements of aerosol properties (MMAD, GSD, etc.) obtained through validated laboratory testing methods (e.g., in accordance with USP 40 Aerosols, Nasal Sprays, Metered-Dose Inhalers, and Dry Powder Inhalers). There are no human experts, adjudication, or MRMC studies involved because it's a hardware performance test, not an AI diagnostic tool.
- Training Set: Not applicable, as this is a hardware device, not an AI/ML algorithm.
In summary, the provided document does not pertain to an AI/ML device and thus the specific questions about AI/ML acceptance criteria and study design elements (like expert readers, MRMC, training sets, etc.) cannot be answered from this text.
§ 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).