(57 days)
The Hoffmann® II Miami Post is used for treating fractures, performing arthrodeses, and distraction osteogenesis of long bones, i.e., tibia, femur and humerus. It also provides stabilization of open and/or unstable fractures and where soft tissue injury precludes the use of other fracture treatments such as IM rodding or casting. It is to be used to provide a hybrid construct combing any 6mm external fixation ring to the Hoffmann® II rod to rod and pin to rod clamps. The post will extend the use of the Hoffmann® II External Fixation System to Hybrid frames that utilize circular rings with 6mm mounting holes.
The Hoffmann® II Miami Post is designed to connect rings with 6mm holes to Hoffmann®II rod to rod and pin to rod clamps. This Post attaches the circular fixation rings to the external fixations rods. The Post is manufactured from Stainless Steel and is machined from bar stock.
The provided text is a 510(k) summary for the Hoffmann® II Miami Post, a component of an external fixation system. It states that "Testing of this device demonstrates substantial equivalence to another predicate ring system." However, it does not contain details about specific acceptance criteria, study methodologies, sample sizes, ground truth establishment, or comparative effectiveness studies (MRMC or standalone) as requested.
Therefore, I cannot provide a detailed answer to your request based on the given information. The document focuses on demonstrating substantial equivalence through similarities in intended use, materials, design, and operational principles, rather than presenting a detailed performance study against specific acceptance criteria.
§ 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.