(108 days)
Synthes 3.5mm LCP Hook Plate is indicated for fractures, osteotomies and non-unions of small bones including the ulna, radius, tibia and fibula, particularly in osteopenic bone.
The Synthes 3.5mm LCP Hook Plate is a low-profile, pre- contoured bone fixation plate intended for the treatment of fractures, osteotomies, and non-unions in small bones. The plates feature a preformed dual hook on one end and arc available in stainless steel and titanium.
This 510(k) summary describes a traditional medical device (bone fixation plate), not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, ground truth, and AI/ML specific performance metrics (like MRMC studies or human reader improvement with AI) is not applicable.
The 510(k) summary for the Synthes (USA) 3.5mm LCP Hook Plate focuses on demonstrating substantial equivalence to a predicate device based on material, design, and intended use. There are no performance criteria or studies of the type requested for AI/ML devices.
Summary of the provided information:
- Device Name: Synthes (USA) 3.5mm LCP Hook Plate
- Intended Use: Fractures, osteotomies, and non-unions of small bones (ulna, radius, tibia, fibula), particularly in osteopenic bone.
- Predicate Device: Synthes One-Third Tubular DCL Plate
- Classification: Class II, §888.3030 - Single / multiple component metallic bone fixation appliance and accessories.
The document states "Information presented supports substantial equivalence" but does not detail a specific performance study with acceptance criteria in the context of AI/ML evaluation.
§ 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.