(42 days)
The Growth Control Plating System is designed for redirecting the angle of growth of long bone(s) in pediatric patients. This is useful for gradually correcting angular deformities in pediatric patients with an open physis. Specific conditions/diseases for which the device will be indicated include valgus, varus, or flexion extension deformities of the knee (femur and/or tibia); valqus, varus or plantar flexion deformities of the ankle, valgus or varus deformities of the elbow, as well as radial or ulnar deviation, flexion or extension deformities of the wrist (radius).
The Growth Control Plating System consists of plates and screws, all of which are comprised of Ti-6Al-4V.
The provided text describes a 510(k) premarket notification for the "Growth Control Plating System." This document is focused on establishing substantial equivalence to a predicate device based on technological characteristics and non-clinical testing. It explicitly states that no clinical testing was performed or provided as a basis for substantial equivalence.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, nor can I provide information on sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, specific types of ground truth, or training set details.
The document indicates:
- Clinical Testing: None provided as a basis for substantial equivalence.
This means that the information you are requesting regarding "acceptance criteria" based on clinical performance and a "study that proves the device meets the acceptance criteria" is not present in the provided 510(k) summary. The device's clearance was based on demonstrating "substantial equivalence" through non-clinical testing and technological comparisons to a legally marketed predicate device (Guided Growth Plate K031493 University of Utah School of Medicine).
§ 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.