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FIRST FILL R.C.S. is to be used for permanent obturation of root canals of teeth in combination with root canal points.

FIRST FILL R.C.S. is to be used for permanent obturation of root canals of teeth in combination with root canal points. The resins used in First Fill RCS are the common dental methacrylate resins.

The provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) summary for a dental root canal sealant (FIRST FILL R.C.S.) seeking substantial equivalence to a predicate device.

Specifically, the document states:

• No acceptance criteria: The document does not define any specific performance metrics or thresholds that the device needed to meet.
• No performance study: There is no description of a study conducted to assess the performance of FIRST FILL R.C.S. against any criteria. The basis for clearance is substantial equivalence.
• Substantial Equivalence: The primary information provided is that Jeneric/Pentron, Inc. believes FIRST FILL R.C.S. is "substantially equivalent to Ultradent's EndoRez Root Canal Sealant, K992097" and that the FDA concurred with this determination based on the premarket notification. The materials are noted as "common dental methacrylate resins" and "Cytotoxicity results have been submitted in Section 15.0" (though Section 15.0 is not provided).

Therefore, I cannot populate the requested table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment, as this information is not present in the provided text.

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