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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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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.

The Symphony Graft Delivery System Syringe is designed specifically to collect, mix and deliver bone graft materials to a surgical site. The Graft Chamber component of the Symphony GDS can be provided either empty or pre-filled with human allograft

The provided text describes the 510(k) summary for the Symphony Graft Delivery System (K012738), which is a device intended for the delivery of bone graft materials. However, the document does not contain information about acceptance criteria, device performance metrics, or any study involving human readers or ground truth establishment.

The "PERFORMANCE DATA" section only states that the resins used for the device components meet biocompatibility requirements (Tripartite Biocompatibility Guidance for Medical Devices, Pharmacopeia XXII, Class VI, and FDA modified ISO 10993-1 tests). This is a statement about material safety and biocompatibility, not about the performance of the device in its intended use (delivery of graft material).

Therefore, I cannot provide the requested information from the given text. The text does not describe a study that proves the device meets specific performance acceptance criteria related to its function of delivering bone graft materials.

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device