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Norian SRS Fast Set Putty is intended only for bony voids or defects that are not intrinsic to the stability of the bony structure. Norian SRS Fast Set Putty is intended to be placed into bony voids or gaps of the skeletal system (the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product 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. SRS Fast Set Putty components are supplied sterile in two separate containers. It is prepared for use by manually mixing two components within a cup using a spatula. The mixing cup and spatula are included in the device packaging. Once combined into a uniform consistency, the product can be shaped and contoured by hand. Norian SRS Fast Set Putty is gradually resorbed over time. This material is provided sterile and is for single use only.

Based on the provided text, the document is a 510(k) Summary for a medical device (Norian SRS Fast Set Putty) and the FDA's clearance letter. This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

It does not contain information about acceptance criteria for device performance studies, nor does it describe any specific study that proves the device meets such criteria.

The document primarily focuses on:

• Device classification and description.
• Indications for Use and Contraindications.
• Identification of a predicate device (Norian SRS Fast Set Putty, K041842).
• A statement of substantial equivalence to the predicate in terms of material composition, physical properties, and performance characteristics.

Therefore, I cannot fulfill the request to provide the detailed information about acceptance criteria and device performance studies, 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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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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