(67 days)
Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation. Specifically, the components can be used for:
- Stabilization of soft tissues and fractures
- Polytrauma/multiple orthopedic trauma
- Vertically stable pelvic fractures, or as a treatment adjunct for vertically unstable pelvic fractures
- Arthrodeses and osteotomies with soft tissue problems; failures of total joints
- Neutralization of fractures stabilized with limited internal fixation
- Non-unions/septic non-unions
- Intra-operative reductions/stabilization tool to assist with indirect reduction
- Unilateral rectilinear bone segment transport or leg lengthening
The Synthes Large External Fixation, MR Conditional consists of previously cleared clamps, rods, Schanz screws and Steinmann pins. Synthes will also offer Sterile Packaged Large External Fixation Kits, MR Conditional. These kits contain previously cleared external fixation devices and manual surgical instruments.
The provided text is a 510(k) summary for the Synthes Large External Fixation, MR Conditional device. It details the device's technical specifications, indications for use, and its substantial equivalence to predicate devices. However, the document does not contain information about acceptance criteria, device performance studies, sample sizes for test or training sets, ground truth establishment, expert qualifications, or MRMC studies.
Therefore, I cannot provide the requested table and study details based on the given input. The document focuses on regulatory approval based on equivalence rather than detailed performance study reporting.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.