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The Symphony Graft Delivery System is indicated for the delivery of allograft, autograft, or synthetic bone graft materials to an orthopedic surgical site. In addition, it is designed to facilitate pre-mixing of bone graft materials with I.V. fluids, blood, plasma, platelet rich plasma, bone marrow or other specific blood component(s) as deemed necessary by the clinical use requirements.

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The provided text does not contain information about acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, or specific study types (MRMC or standalone) related to an AI/ML device.

The document is a 510(k) summary and an FDA clearance letter for a medical device called the "Symphony Graft Delivery System." It describes the intended use and materials of the device, and states that "All medical grade materials have undergone biocompatibility testing in accordance with US Pharmacopoeia XXII Class VI guidelines." This indicates that biocompatibility testing was performed for the materials used in the device to ensure they meet safety standards.

However, the information requested in your prompt (especially related to AI/ML device performance metrics, reader studies, ground truth establishment, and training data) is not present in this regulatory document, as the device described is a physical medical instrument (a piston syringe for delivering bone graft materials) and not an AI/ML powered diagnostic or assistive device.

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