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GC Elite Cement 100 is a zinc phosphate cement used for cementation of crowns, bridges and inlays.

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The provided document is a 510(k) premarket notification letter for a dental cement (GC Elite Cement 100). It establishes substantial equivalence to a predicate device, allowing it to be marketed.

However, this document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria related to a medical device's performance in terms of diagnostic accuracy or clinical outcomes.

The letter from the FDA primarily addresses regulatory aspects, classification, and general controls for the device. It indicates that the device is a "Dental Cement" and provides its "Indications For Use" which is for "cementation of crowns, bridges and inlays."

Therefore, I cannot provide the requested information from the given text as it does not describe device performance criteria, a study, or any of the detailed aspects about clinical performance evaluation that your request asks for (e.g., sample size, data provenance, expert qualifications, ground truth, MRMC study, standalone performance, training set details).

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