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Prilane is indicated as part of a system to repair fractured dental porcelain and to bond all porcelain restorations. The system involves etching the porcelain and then applying a small amount of Prilane to the etched surface.

Prilane is a silane coupler, a device that when applied to inorganic surfaces such as dental porcelain, will chemically bond to the porcelain and will then bond to the organic thermoset resins that are commonly used as luting agents and restorative materials in dentistry. The above results in: Improved adhesion. Increased composite wet & dry strength. Increased composite wet & dry flexural strength. Prilane is a clear, low viscosity liquid having a pH of 6. Prilane is a prehydrolized silane. The hydrolization involves adding a small amount of water (.125%) to the silane. The hydrolization reaction causes the silane to be both organic and inorganic reactive. The silane material is Dow Corning Z-6030 which is -methacryloxypropyctrimethoxy silane.

The document provided is a 510(k) summary for the device "Prilane," a silane coupler used in dentistry. It states the intended uses and compares Prilane to legally marketed predicate devices.

However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies. The provided text is purely a regulatory submission outlining the device's description, intended use, and substantial equivalence to existing products, without any performance data or a study report.

Therefore, I cannot fulfill your request for the table of acceptance criteria and device performance, nor can I provide details on the study that proves the device meets acceptance criteria, as this information is absent in the document.

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