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SmartSet HV Bone Cement is indicated for the fixation of prostheses to living bone in orthopaedic musculoskeletal surgical procedures for rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma or other conditions, and revision of previous arthroplasty.

SmartSet GHV Gentamicin Bone Cement is indicated for use in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.

SmartMix Cemvac is a vacuum mixing and syringe delivery system pre-packed with bone cement powder and liquid. The device is available in a single 60g or 80g unit. This submission adds SmartMix Cemvac pre-filled with SmartSet HV Bone Cement and SmartMix Cemvac pre-filled with SmartSet GHV Gentamicin Bone Cement to the SmartMix Cemvac line.

The provided document is a 510(k) summary for a bone cement mixing and delivery system. It describes the device, its intended use, and its substantial equivalence to previously cleared devices. However, this document does not contain any information about acceptance criteria or a study proving device performance against such criteria for a diagnostic AI/ML device.

The document states: "Based on the similarities of design, materials, intended use and testing results, SmartMix Cemvac pre-filled with SmartSet HV Bone Cement and SmartMix Cemvac pre-filled with SmartSet GHV Gentamicin Bone Cement are substantially equivalent to the same bone cements, packaged in traditional bone cement packaging." This indicates that the regulatory clearance was based on demonstrating equivalence to existing legally marketed devices, rather than a performance study against specific diagnostic acceptance criteria.

Therefore, I cannot provide the requested information for an AI/ML device based on the given input.

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