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The GraftGun Universal Graft Delivery System (GDS®) is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site, via direct visualization or minimally invasive.

The GraftGun Universal Graft Delivery System (GDS®) consists of a sterile, single-use, disposable device, and non-sterile reusable Adapter Tips intended for the delivery of prepared allograft, autograft, or synthetic bone graft material to an orthopedic surgical site. The GraftGun Universal Graft Delivery System (GDS®) includes the GraftGun Dispensing Unit, Loading Device, Graft Tubes, and Adapter Tips.

The provided text describes a medical device, the GraftGun Universal Graft Delivery System (GDS®), and its 510(k) clearance process. However, this document does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an Artificial Intelligence (AI) or machine learning (ML) system.

The device described is a piston syringe used for delivering bone graft material. The performance testing mentioned (Compatibility Assessments, Sterilization Validations, Cleaning Validations, Biocompatibility Assessment, Package Performance, Shelf-Life Testing) are standard tests for mechanical medical devices to ensure their safety, functionality, and sterility. They are not related to AI/ML performance metrics such as sensitivity, specificity, AUC, or reader studies.

Therefore, I cannot fulfill your request for the specific details about AI/ML acceptance criteria and study data based on the provided text. The document is for a non-AI/ML device.

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