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CONCORD Plus™ Radiopaque 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 cancers, myeloma).

The CONCORD Plus™ Radiopaque Bone Cement is a high-viscosity, radiopaque, self-curing, PMMA bone cement. It is provided sterile, as a two component system, a liquid component and a powder component which are mixed together prior to use to form the cement. The bone cement is intended for single use only.

I am sorry, but based on the provided text, there is no information available regarding an AI device, its acceptance criteria, or a study proving it meets those criteria.

The document is a 510(k) premarket notification for a medical device called "CONCORD Plus™ Radiopaque Bone Cement." This is a physical bone cement, not an AI or software-as-a-medical-device.

Therefore, I cannot provide the requested information in the table format or answer the questions related to AI device performance, sample sizes, ground truth establishment, or expert reviews. The text discusses the bone cement's physical and chemical properties, sterilization methods, and comparison to predicate devices, all of which are irrelevant to AI device evaluation.

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