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Norian SRS Fast Set Putty is indicated only for filling bony voids or gaps that are not intrinsic to the stability of the bony structure. The putty is to be gently packed into bony voids or gaps of the skeletal system including the extremities, spine, and pelvis. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. SRS Fast Set Putty provides a bone void filler that resorbs and is replaced with bone during the healing process.

Norian SRS Fast Set Putty is a self-setting calcium phosphate 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.

The provided text is a 510(k) summary for the Norian SRS® Fast Set Putty, a medical device. This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner typically described for AI/ML devices or diagnostic accuracy studies.

The document is a premarket notification to the FDA, demonstrating substantial equivalence to previously marketed devices. It confirms the device's classification, describes its components and indications for use, and states that documentation was provided to show substantial equivalence. There is no information regarding a study with a test set, ground truth, expert review, or statistical performance metrics.

Therefore, I cannot provide the requested information in the table format or specific details about a study, as such a study is not described or referenced in the provided text. The context of this document is a regulatory submission for a physical medical device (bone void filler) based on substantial equivalence, not an AI/ML algorithm or a diagnostic test with performance criteria.

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