(197 days)
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.
§ 878.4820 Surgical instrument motors and accessories/attachments.
(a)
Identification. Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.