(107 days)
The Harvest Graft Delivery System is intended for the aspiration of bone marrow, autologous blood, plasma, or other body fluids. The 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 the aspirate(s), 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 Harvest Graft Delivery System consists of a Graft Syringe/Infusion Chamber with pre-seated polymer plug and removable plunger and syringe cap; a dual liquid applicator; female/female luer connector and push rod. A commercially available bone marrow aspirate needle is supplied separately for use with the system.
I am sorry, but based on the provided text, I cannot provide a table of acceptance criteria and reported device performance or information about a study proving the device meets acceptance criteria.
The document is a 510(k) Summary for the Harvest Graft Delivery System, which describes the device, its intended use, and states its substantial equivalence to predicate devices based on technological characteristics (similar design and configuration). It does not contain details of any specific performance studies with acceptance criteria, sample sizes, ground truth, or expert involvement.
The 510(k) process for this device (a Piston Syringe) relies on demonstrating substantial equivalence to legally marketed predicate devices, primarily based on design, intended use, and technological characteristics, rather than requiring extensive clinical performance studies with specific statistical acceptance criteria as might be seen for novel or higher-risk devices.
Therefore, I cannot answer the requested points (1-9) as the information is not present in the provided text.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).