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FibriJet® Graft Delivery System is intended for the delivery of hydrated allograft, autograft or synthetic bone graft material to an orthopedic surgical site. In addition, it is designed to facilitate the premixing of bone graft materials with fluids such as I.V. fluids, blood, plasma concentrate, platelet rich plasma, bone marrow or other specified blood components deemed necessary by the clinical use requirements.

The FibriJet® Graft Delivery System consists of the Graft Delivery Device, a dual liquid applicator, a blending connector and cups and lids. The Graft Delivery Device itself consists of a syringe barrel, end cap, plunger and funnel.

This 510(k) premarket notification for the FibriJet® Graft Delivery System does not contain the acceptance criteria or a study that proves the device meets specific performance acceptance criteria.

The document is a submission for regulatory clearance, primarily focusing on demonstrating substantial equivalence to predicate devices. It describes the device, its intended use, and provides contact information. It does not include:

• A table of acceptance criteria and reported device performance: There are no specific performance metrics (like delivery accuracy, consistency, force required, etc.) or corresponding acceptance limits mentioned.
• A study demonstrating performance: The document does not describe any clinical or non-clinical study that evaluated the device's performance against predefined acceptance criteria. Therefore, information regarding sample size, data provenance, ground truth establishment, expert involvement, or comparative effectiveness studies is absent.

The FDA's response (pages 1-2) confirms that they have reviewed the submission and found the device substantially equivalent. This type of clearance typically relies on comparing the new device's design, materials, and intended use to existing, legally marketed predicate devices, rather than requiring extensive de novo performance studies with specific acceptance criteria, especially for a Class II device like a piston syringe.

In summary, as per the provided text, the information requested in your bullet points regarding acceptance criteria and performance study results is not available. The document is a regulatory submission for substantial equivalence based on technological characteristics similar to predicate devices, not a detailed performance study report.

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