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The AV Core System is a system of cannulated trephines and drills used to obtain and insert a contoured bone graft into a matched hole in the femoral head. The use of the system is indicated for patients suffering from Avascular necrosis, in which the head does not suffer from collapse or degenerative changes.

The AvCore System comprises of a series of trephines and purchased canulated drill bits of matched size, used to obtain a appropriate sized and contoured bone graft in the treatment of avascular necrosis of the femoral head. The device is classified under the nomenclature of drills, burs, Trephines & accessories ( compound, powered). The product code is 84HBF and regulation number 882:4305 and is a Class II device.

I'm sorry, but based on the provided text, there is no information available regarding the acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria.

The document is a 510(k) summary for the AvCore System, which is a set of trephines and drills used to obtain and insert bone grafts for avascular necrosis of the femoral head. The focus of the document is on establishing substantial equivalence to pre-amendment devices and other currently marketed trephines, rather than on reporting on specific performance studies or acceptance criteria for the AvCore System itself.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer the detailed questions about studies, sample sizes, ground truth, experts, or MRMC studies.

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The Euclid Reduction and Positioning System is an adjunct to any intramedullary rod to aid in both the reduction of a femur fracture and to aid in the targeting of the distal screws placed across the rod. It is considered to aid in any type femur fracture for which intramedullary rod fixation is indicated.

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I am unable to assist with this request. The provided text is a letter from the FDA regarding a medical device, but it does not contain the information needed to answer the questions about acceptance criteria and a study proving device performance. The letter only states that the device is substantially equivalent to previously marketed devices.

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