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The Neb-90™ Large Volume Medication Nebulizer is indicated for the continuous aerosol administration of respiratory medication (inhalable solution) including, but not necessarily limited to, beta adrenergic bronchodilator (albuterol sulfate) and/or a wetting agent such as sodium chloride solution (saline) that is used for the treatment of respiratory and related diseases and conditions including, but not necessarily limited to asthma, COPD, bronchiolitis and cystic fibrosis. The Neb-90™ Large Volume Medication Nebulizer is for use in hospital Emergency Department, ICU or other similar settings for delivery of aerosolized medication to patients undergoing severe respiratory distress.

The Nebulizer is a single patient/single use device which is filled with a fluid, typically respiratory medication and connected to a gas source via flexible tubing. The nebulizer works by Pavipng a cluid come into contact with the stream of gas. The gas shatters the liquid into small particles. These particles then impact a baffle that further reduces the size of the particles. The majority of the larger particles settle inside the nebulizer as a result of gravity and inertia, returning the mist to liquid to repeat the nebulization process. The smaller particles are then administered as the patient inhales. The treatment is completed when the majority of liquid has been nebulized.

The provided text describes a 510(k) summary for the Neb-90™ Large Volume Medication Nebulizer but does not include any acceptance criteria or details of a study demonstrating the device meets such criteria.

The document states that the Neb-90™ is a single-patient/single-use device for the continuous aerosol administration of respiratory medication. It also mentions that "Specific issues, as mentioned in 'CDRH Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators; October 1, 1993' are addressed herewith," but the document does not elaborate on what these issues are or how they were addressed with data.

Therefore, based on the provided input, I cannot generate the requested table or answer the questions regarding acceptance criteria and study details. The 510(k) summary focuses on device description, predicate devices, general device characteristics, and the FDA's clearance letter, but it omits the specific performance data and acceptance criteria that would typically be found in a study report.

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