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Pall Medical's Dental Unit Waterline Filtration system safely and effectively reduces bacteriological contaminants and endotoxins, and waterborne particulate matter from dental waterlines. The system consists of reusable filter housings and disposable filter elements. This point-of-use system is designed to retrolit existing dental waterlines.

Pall Medical's Dental Unit Waterline Filtration system with Air Water Syringe Housing and Filtration Membrane. The system consists of reusable filter housings and disposable filter elements.

Unfortunately, this document does not contain the information requested regarding acceptance criteria and a study proving device performance.

The document is an FDA 510(k) clearance letter for the "Pall Dental Filtration System with Air Water Syringe Housing and Filter Membrane." This letter indicates that the device has been found substantially equivalent to a legally marketed predicate device, allowing it to be marketed.

However, the letter does not include any technical details about performance studies, acceptance criteria, sample sizes, ground truth establishment, or expert involvement. These details would typically be found in the 510(k) submission itself, which is not provided here.

Therefore, I cannot fulfill your request to create a table of acceptance criteria and reported device performance or answer the specific questions about the study design, as this information is absent from the provided text.

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