Search Results

The Model 8960 Series Nebulizers have the same intended use as their predicate device, The Salter Model 8900 Nebulizer, which was cleared for marketing by 510(k) No. K870027. The nebulizer is a disposable device which is used where liquids are to be delivered to a patient in an aerosol form. The device is not life-supporting or life-sustaining, nor is it implanted . It does not use software, nor is it sterile. The device is for single patient use. It is intended to be used with accessories, such as masks and tubing which are industry standard devices used with nebulizers.

Each of the Salter Labs 8960 Series Nebulizers consists of a Nebulizer Top which is screwed onto a Nebulizer Cup. The bottom of the cup has a fitting to accept a source of nebulizing gas. Liquids to be nebulized are placed in the nebulizer cup. The nebulizer housing is then applied, and the supply line for the nebulizing gas source is then connected to the bottom of the nebulizer cup. After the pressurized nebulizing gas is applied to the nebulizer, the solution in the cup is nebulized and pushed from the unit in aerosol form that can be inhaled by the patient.

The provided text is a 510(k) summary for a medical device (nebulizer). It does not contain information about acceptance criteria, performance studies, or any of the other requested details regarding an AI/ML medical device.

The document describes a mechanical device (nebulizer) and compares it to a predicate device, focusing on its physical characteristics and intended use. There is no mention of algorithms, software, AI, or any data analysis that would require the information requested in your prompt (e.g., sample sizes, expert ground truth, adjudication methods, MRMC studies, training sets).

Therefore, I cannot fulfill your request based on the provided input.

Ask a specific question about this device