(30 days)
The AlignX Ankle Fusion System is intended to facilitate arthrodesis of the ankle including tibiotalocalcaneal and tibiotalar joints.
The AlignX Ankle Fusion System is a bone fixation device consisting of an anatomical, anterior and lateral tibia plates and various locking and non-locking screws and a set of instruments used for implant site preparation and delivery. The plates are available in various geometries. The anterior plate is available three configurations, a slim plate and a 2-tab plate (available in two widths). A central hole in the plate allows for angled placement of a "home run" screw to obtain axial compression across the tibiotalar (TT) or (tibiotalarcalcaneal) (TTC) joints. The 2-tab plate is designed with an anterior "window" to allow autologous grafting of the TT and visualization of fusion under fluoroscopy. The lateral plate is available in two geometries, one for tibiotalar (TT) joint fusion and one for tibiotalarcalcaneal (TTC) fusions.
The provided text is a 510(k) summary for a medical device called the "AlignX Ankle Fusion System." This summary does not include acceptance criteria or the results of a study proving a device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices through engineering analysis and the assertion that no clinical testing was performed.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample size, ground truth, or expert qualifications based on the given text.
The document states:
- "No clinical testing was performed."
- "An engineering analysis demonstrated that the new plates and screw sizes do not introduce a new worse case in terms of strength."
This indicates that equivalence was established through non-clinical testing (engineering analysis) and comparison to predicate devices, rather than through a study with acceptance criteria often seen with performance claims for AI/ML devices or diagnostic tools.
§ 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.