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The Avitus® DragonWing Large Volume Autograft Delivery System is intended to be used for the delivery of autograft or hydrated allograft bone graft material to an orthopaedic surgical site.

The Avitus® Dragonwing™ Large Volume Autograft Delivery System is designed to deliver bone autograft or hydrated allograft material to an orthopaedic surgical site. The device delivers approximately up to 5cc of bone graft material per each reloadable five-channel cartridge. Each system comes with the following:

• · 2 x Graft Cartridge Features 5 graft channels, a latching lid, and connection points to the Delivery Cannula.
• · 1 x Bone Scoop Accessory Used to add graft to the Graft Cartridge channels.
• · 1 x Pack Tool Accessory Used to compress graft into the Graft Cartridge channels.
• · 1 x Delivery Cannula Features a handle frame which connects to a loaded Graft Cartridge and a straight-tipped cannula through which graft material is delivered to the orthopaedic surgical site.
• · 1 x Delivery Plunger Features a plunger rod and handle. During graft delivery, the Delivery Plunger is pushed through a Graft Cartridge channel to deploy graft material to the orthopaedic surgical site.

The provided text describes a 510(k) premarket notification for a medical device called the "Avitus® DragonWing Large Volume Autograft Delivery System." It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML-based medical device.

The document discusses:

• The device's name, regulation number, and product code.
• The intended use of the device (delivery of autograft or hydrated allograft bone graft material).
• A comparison to a predicate device (Spinal Surgical Strategies, LLC Bi-Portal Bone Graft Delivery Device cleared under K142661).
• Technological characteristics like materials, mechanism of operation, recommended graft volume, bone graft exit hole configuration, and sterilization method.
• Non-clinical testing performed: device performance testing (using cadaveric bone graft material), sterilization validation, package integrity testing, shelf-life testing, and biocompatibility testing.
• A explicit statement that no clinical testing was performed for this submission.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study that proves the device meets the acceptance criteria for an AI/ML device, as this document pertains to a physical medical device (syringe/delivery system) and does not involve AI or ML.

If you have a document describing an AI/ML medical device, please provide that text, and I will be happy to extract the relevant information.

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