(45 days)
Synthes LCP Proximal Tibia Plate is intended treatment of non-unions, malunions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures.
The Synthes LCP Proximal Tibia Plates are contoured to match the anatomy of the proximal tibia with a limited contact low profile design. There are plates designed for either the right or left tibia in a variety of shaft lengths. These plates will be available in both 3.5 mm and 4.5 mm versions. The plates are available in a variety of lengths. The locking screw holes accept both cannulated locking and conical screws. Two proximal round holes accept cortex screws, cancellous screws, or cannulated screws. The distal portion of the plate has combination dynamic compression locking screw holes that allow the option of using locking screws, cortex screws, or cannulated screws.
This document is a 510(k) Pre-Market Notification from the FDA for a medical device (Synthes LCP Proximal Tibia Plate). It does not contain any information regarding acceptance criteria, study designs, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or ground truth establishment relevant to AI/ML device evaluations.
The provided text describes a traditional Class II medical device (bone fixation plate) and its regulatory clearance process based on substantial equivalence to a predicate device. This process typically involves demonstrating:
- Substantial Equivalence: The new device is as safe and effective as a legally marketed predicate device. This is usually achieved by comparing indications for use, technological characteristics, and performance data (e.g., mechanical testing, biocompatibility).
The information requested in your prompt (relating to acceptance criteria, sample sizes, expert ground truth, MRMC studies, standalone performance, etc.) is specific to the evaluation of AI/Machine Learning (AI/ML) powered medical devices, particularly those that generate diagnostic or prognostic outputs that need to be compared against a 'ground truth' established by human experts or other definitive methods.
Since the provided document is for a mechanical bone plate, it does not involve AI/ML and therefore does not include the type of information you are asking for.
Therefore, I cannot provide the requested information based on the input text.
§ 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.