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The Disc-O-Tech Confidence EX High Viscosity Bone Cement is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancer, myeloma).

The Confidence EX High Viscosity Bone Cement is a radiopaque, self-curing, high viscosity PMMA bone cement. It is provided sterile, as a two-component system (22.5 g powder (polymer) and 9.2 g liquid (monomer)), which are mixed prior to use to form the cement. The powder component contains 30.07 % barium sulfate.

The provided text is a 510(k) summary for a medical device (bone cement), and it does not contain information typically found in a study proving a device meets acceptance criteria for an AI/software as a medical device (SaMD) product. The document focuses on establishing substantial equivalence for the bone cement itself, primarily based on material properties and intended use.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth, experts, or MRMC studies, as these concepts are not applicable to the content of this 510(k) summary. These details would be relevant for a software-based device that performs a diagnostic or prognostic function, not for a PMMA bone cement.

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