Search Results

The Avitus(TM) Bone Harvester is intended to harvest cancellous bone and marrow.

The proposed device is a manual surgical instrument that cuts cancellous bone by manual actuation of the cutting tip. The cap contains a barbed nozzle that connects to standard sized suction tubing (tube with an ID of 6-10 mm) to connect to a vacuum source, wherein the vacuum source has a static maximum pressure between 150 mmHg. The proposed device can be connected to a waste canister that leads to standard operating room wall suction or to an external pump. With the device connected to a vacuum source, when actuated in bone the cutting tip carves, scrapes and cuts cancellous bone and collects the bone graft inside the handle. The suction pulls the bone marrow from the cutting tip and into the bone reservoir inside the handle. The cap contains a filter that prevents material from escaping the handle into the suction system by utilizing a physical sieve to keep bone particulate in the handle. After harvesting, the bone graft can be retrieved from the handle.

I am sorry, but the provided text does not contain the acceptance criteria or a study proving the device meets acceptance criteria in the format requested. The document is an FDA 510(k) premarket notification letter for the Avitus™ Bone Harvester, detailing its substantial equivalence to a predicate device and its intended use. It mentions non-clinical testing for load evaluation and tip breakage, and biocompatibility testing, but it does not provide specific acceptance criteria values or detailed study results with the requested parameters.

Therefore, I cannot fulfill your request for the table of acceptance criteria, detailed study information, sample sizes, ground truth establishment, or multi-reader multi-case study results.

Ask a specific question about this device