(43 days)
The Synthes (USA) 3.5 / 4.5mm LCP® Medial Proximal Tibia Plates are intended to buttress metaphyseal fractures of the medial tibia plateau, split-type fractures of the medial tibia plateau, medial split fractures with associated depressions and split or depression fractures of the medial tibia plateau. The plates may also be used for fixation of the proximal quarter (lateral and medial) of the tibia as well as segmental fractures of the proximal tibia. The 4.5mm version may also be used for fixation of nonunions and malunions of the medial proximal tibia and tibia shaft, as well as opening and closing wedge tibial osteotomies.
The Synthes (USA) 3.5 / 4.5 mm LCP® Medial Proximal Tibia Plates are contoured to match the anatomy of the medial proximal tibia with a limited contact low profile design. The plates are designed for either the right or left medial proximal tibia in a variety of shaft lengths. These plates will be available in both 3.5 mm and 4.5 mm versions. The plate head exhibits 2.0 mm holes for preliminary fixation with k-wires, or meniscal repair with sutures.
The provided document is a 510(k) premarket notification for a medical device, the Synthes (USA) 3.5 / 4.5mm LCP® Medial Proximal Tibia Plates. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical studies to prove safety and effectiveness.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, as it would be relevant for a new device requiring de novo authorization or a PMA (Premarket Approval) application.
Here's a breakdown of why the requested information isn't present in this 510(k) submission:
- Acceptance Criteria and Reported Device Performance: This document establishes substantial equivalence by comparing the new device's features, intended use, and materials to a predicate device. It doesn't set specific performance acceptance criteria for a new study.
- Sample Size, Data Provenance, Experts for Ground Truth, Adjudication Method, MRMC Study, Standalone Study, Type of Ground Truth, Training Set Sample Size, and Ground Truth for Training Set: These are all elements of a clinical or technical performance study, which are generally not required for a 510(k) submission unless there's a significant difference from the predicate that necessitates new data. The 510(k) process relies on the established safety and effectiveness of the predicate device.
To summarize, based solely on the provided K050646 document:
The document describes a 510(k) submission for the Synthes (USA) 3.5 / 4.5mm LCP® Medial Proximal Tibia Plates. The purpose of this submission is to demonstrate "substantial equivalence" to a predicate device, not to present new clinical data proving specific performance acceptance criteria. Therefore, the requested information about acceptance criteria, study design, sample sizes, expert involvement, and ground truth methodologies is not available within this regulatory filing.
§ 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.