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PharmaCaribe inhaled saline solutions are used in conjunction with a nebulizer. The contents of these vials are for the induction of sputum production where sputum production is indicated. Concentrations of 3%, 3.5%, 6%, 7%, and 10%

PharmaCaribe Sodium Chloride Solutions are homogeneous mixtures (complete solutions) and are composed of USP sterile water and sodium chloride only and provided in 3%, 3.5%, 6%, 7%, and 10% concentrations. They are packaged sterile in standard 5ml (4ml fill) flexible material vials. The vials have a tear-off top. They are marked NOT FOR INJECTION.

The provided document describes a 510(k) premarket notification for PharmaCaribe inhaled saline solutions. This is not a study proving device performance against acceptance criteria in the context of an AI/ML medical device. Instead, it is a submission for a medical device (saline solutions) demonstrating substantial equivalence to predicate devices already on the market.

Therefore, the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment, which are typical for studies validating AI/ML device performance, are not applicable to this document.

Summary of Device and Approval:

• Device Name: PharmaCaribe inhaled saline solutions 3%, 3.5%, 6%, 7%, and 10%
• Intended Use: For the induction of sputum production where sputum production is indicated, in conjunction with a nebulizer.
• Classification: Class II, Nebulizer (Direct Patient Interface), Product Code CAF
• Predicate Devices: DEY Laboratories - K972778 and Pari - K070498
• Approval Date: August 17, 2010
• Basis of Approval: Substantial equivalence to predicate devices. The device's manufacturing and testing processes (including pH, osmolality, appearance, sterility, identification of sodium and chloride, bacterial endotoxin, iron content, heavy metals content, sodium chloride assay, and stability testing) are identical or similar to the predicate devices and conform to USP monographs.

Non-Applicability of AI/ML Study Criteria:

The questions related to acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are specifically designed for evaluating the performance of AI/ML algorithms. Since the PharmaCaribe inhaled saline solutions are a pharmaceutical-like product (albeit regulated as a medical device) and not an AI/ML system, these criteria do not apply to this 510(k) submission. The "performance testing" referenced in the document refers to chemical and sterility testing to ensure the product meets established standards, not diagnostic or predictive performance.

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