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Fast Set Putty is indicated for repairing or filling craniofacial defects and craniotomy cuts with a surface area no larger than 25cm². Fast Set Putty is also indicated for the restoration or augmentation of bony contours of the craniofacial skeleton, including the fronto-orbital, malar and mental areas.

Fast Set Putty is a putty-like calcium phosphate bone cement characterized by a rapid in situ setting time. The Fast Set Putty components are supplied sterile in two separate containers. The putty is intraoperatively prepared by manually mixing the components within a cup using a spatula. Once complete, the putty can be shaped and contoured by hand.

This document is a 510(k) summary for the Synthes (USA) Fast Set Putty, a calcium phosphate bone cement. It addresses the substantial equivalence to a predicate device and provides details on its intended use and material. However, it does not contain information regarding an acceptance criteria table, a study proving device meets acceptance criteria, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

Therefore, I cannot provide the requested information from the provided text. The document is primarily a regulatory submission for market clearance, focusing on safety and efficacy based on substantial equivalence, rather than a detailed performance study report.

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