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When used with appropriate opening osteotomy system devices, plates and screws, Duowedge is intended to be used as a bone void filler in tibial osteotomies. Duowedge is to be used in combination with adequate post-operative immobilization.

The calcium phosphate ceramic Duowedge manufactured by KASIOS is designed to be used as a bone void filler tibial osteotomies. Duowedge is a synthetic bone substitute. It is a macroporous bioceramic, made of hydroxyapatite and beta tricalcium prosphate. When . it is nony site, Duowedge gradually and partially resorbs and is replaced with bone during the healing process. In addition, Duowedge is intended to be used with appropriate opening osteotomy system devices, plates and screws. Duowedge is for use in combination with adequated postoperative immobilization.

The provided text is a 510(k) summary for the Duowedge device by Kasios. It describes the device, its intended use, and its substantial equivalence to previously cleared bone substitutes. However, it does not contain any information about acceptance criteria, device performance, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance. The document is a regulatory submission for a bone substitute, not an AI/ML medical device.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and study details based on the provided text. The document primarily focuses on demonstrating substantial equivalence to predicate devices based on indications for use, materials, and design, rather than quantitative performance metrics from a clinical study for a new AI/ML product.

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