(119 days)
The Synthes (USA) Pediatric LCP Plate System is indicated for fixation of fractures (including pathologic and impending pathologic fractures) and osteotomies of the femur in infants, children, adolescents and small statured adults.
Specific indications for the 100°, 120°, 130°, 140°, 150° plates include:
• Varus, valgus, rotational and/or shortening osteotomies
• Femoral neck and/or pertrochanteric fractures
• Proximal metaphyseal fractures
• Diaphyseal fractures
• Pathologic fractures
• Prophylactic use for impending pathologic fractures
Specific indications for the 90° plates include:
• Varus, valgus, rotational and/or shortening osteotomies
• Femoral neck and/or pertrochanteric fractures
• Proximal and distal metaphyseal fractures
• Diaphyseal fractures
• Pathologic fractures
• Prophylactic use for impending pathologic fractures
The system is a collection of plates used to treat fractures and osteotomies of the femur in infants, children, adolescents, and small statured adults. The complete system includes the following:
• 3.5mm and 5.0 mm plates with a 90° angle
• 2.7mm, 3.5mm and 5.0 mm plates with a 100° angle
• 2.7mm, 3.5mm and 5.0 mm plates with a 110° angle
• 3.5mm and 5.0 mm plates with a 120° angle
• 2.7mm, 3.5mm and 5.0 mm plates with a 130° angle
• 3.5mm and 5.0 mm plates with a 140° angle
• 3.5mm and 5.0 mm plates with a 150° angle
The system accepts existing cortical and locking screws, and features allows for both dynamic compression and locking through Combi holes. The plates are universally designed for both left and right use.
The provided text describes a medical device, the "Synthes Pediatric LCP Plates," and its regulatory clearance (510(k)). This document, however, does not contain information about acceptance criteria and a study that proves the device meets those criteria in the context of an AI/ML-driven device's performance.
The document is a 510(k) summary for a traditional medical device (bone fixation plates), which primarily focuses on demonstrating substantial equivalence to predicate devices through design characteristics, materials, and engineering strength analysis and fatigue testing.
Therefore, I cannot extract the requested information regarding acceptance criteria, reported device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to an AI/ML device. These concepts are not applicable to the type of device and regulatory submission described in the input.
§ 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.