(26 days)
Stabilization of open and/or unstable fractures of the distal radius, where soft tissue injury may preclude the use of other fracture treatments such as IM rodding, casting and other means of external fixation.
The device is an external wrist fixator made of radiolucent polymer, polycarbonate. The fixator is a non-bridging device, which means that it does not cross the wrist. A non-bridging device gives patients the ability to utilize wrist function.
The device consists of two plates with multiple pin holes. Pins are inserted through the plates, into the bone and held in place by the interference of the two plates. The plate has an external bracket that allows pins to be inserted from the side for additional fixation. If desired, distraction of the fracture site may be achieved with adjustment of a threaded pin placed within a slot on the distal end of the plate.
The provided document is a 510(k) premarket notification for a medical device, the NBX - Non-Bridging External Fixator. It focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study proving the device meets specific acceptance criteria through clinical or analytical performance testing.
Therefore, the specific information requested in the prompt (acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) is not available in this document.
Here's why:
- The document states under "Clinical Testing: None provided."
- The primary purpose of a 510(k) submission for this type of device is often to demonstrate substantial equivalence through technological characteristics and non-clinical (mechanical) testing, as indicated by "Non-Clinical Testing: Mechanical testing was conducted to insure the design changes would not effect the safety of the device."
Without clinical testing or detailed analytical performance studies, there are no acceptance criteria, reported device performance metrics, or study designs to describe in the way your prompt expects.
§ 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.