Search Results

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.

Ask a specific question about this device