(83 days)
The VHS™ Pediatric Hip Screw System is used for fracture fixation in the proximal and distal regions of the femur. In particular, indications for use in pediatric patients are as follows :
- Congenital coxa vara.
- Congenital dislocation of the hip
- Subluxation or dislocation secondary to neurologic disorders, such as cerebral palsy, myelomenigocele, poliomyelitis, etc. Usually valgus-anteversion deformities.
- Coxa plana ( Legg-Calve-Perthes disease )
The VHS™ Pediatric Hip Screw System is a compression fixation system used for the treatment of femoral fractures. It consists of adjustable plates, lag screws, compression screws and bone screws. Materials: The devices are manufactured from 316 LVM or 22-13-5 stainless steel per ASTM standards. Function: The system functions to provide immediate stability and temporary fixation during the natural healing process following fractures of the distal femur.
The provided text is a summary of a 510(k) premarket notification for the VHS™ Pediatric Hip Screw System. This document focuses on establishing substantial equivalence to existing devices, which is a regulatory pathway for medical devices. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way a clinical or technical validation study would for an AI/ML device.
The 510(k) process for this type of medical device generally relies on demonstrating that the new device has the same intended use and technological characteristics as a predicate device, and that any differences do not raise new questions of safety or effectiveness. Performance data would typically involve mechanical testing to ensure material strength and functional integrity, but these specific details are not provided in this summary.
Therefore, I cannot fulfill your request for information related to acceptance criteria, a study proving the device meets them, sample sizes, expert involvement, or AI/ML specific evaluations (such as MRMC studies, standalone performance, or ground truth establishment for training data). This document is not the appropriate source for such information.
§ 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.