(116 days)
The Flex-Thread™ Distal Fibula Intramedullary Nail System is intended for use in the fixation of fibula fractures and osteotomies.
The Flex-Thread™ Distal Fibula Intramedullary Nail System is comprised of an intramedullary fixation device with a flexible threaded tip to engage the proximal portion of a fibula and cortical screws to further enhance stability and fixation of the fibula.
The provided text describes a medical device, the "Flex-Thread™ Distal Fibula Intramedullary Nail System," and its 510(k) submission for FDA clearance. However, the document does not contain information related to software or AI performance.
Therefore, I cannot extract acceptance criteria or study details regarding device performance from the provided text in the context of an AI/Software device. The submission focuses on the mechanical and functional equivalence of the intramedullary nail system to a previously cleared predicate device.
Specifically, the "Non-Clinical and/or Clinical Tests Summary & Conclusions" section on page 4 details mechanical testing and a cadaver lab simulation, which are relevant to the physical device's characteristics and use, not software performance.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.