(112 days)
OsteoMed Wrist Plating System is intended for fracture fixation, fusion and osteotomies of wrist and other bones appropriate for the size of the device. It is intended for use in trauma, general surgery and reconstructive procedures.
OsteoMed Wrist Plating System implants are intended for single use only.
The OsteoMed Wrist Plating System is a rigid fixation and fusion system , consisting of plates and screws in various configurations along with the appropriate instrumentation to facilitate modification, implantation, or removal of the implants. Plates are anatomically pre-contoured in various shapes and sizes. Screws are provided with variable angle locking or non-locking head in various lengths. These screws are either solid core or cannulated and can be used with or without plates.
Plates and screws are supplied in a variety of configurations. The plates and screws are made of titanium alloy (ASTM F136). K-wires are made of titanium alloy (ASTM F136) or stainless steel (ASTM F138). The instrumentation is made from various grades of stainless steel, anodized aluminum, and/or medical grade polymers.
The provided text describes a 510(k) summary for the OsteoMed Wrist Plating System. This document focuses on demonstrating substantial equivalence to already legally marketed predicate devices, rather than conducting a de novo clinical study with specific acceptance criteria, sample sizes, and ground truth establishment for novel device performance.
Therefore, the requested information regarding acceptance criteria, a study proving device meeting these criteria, sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment for the training set is not applicable or available within this 510(k) submission.
The document states:
- "Analyses of plate and screw strength were conducted to compare the OsteoMed Wrist Plating system components to predicate devices." This implies mechanical bench testing for equivalence, not a clinical study with performance metrics like sensitivity, specificity, or accuracy.
- "Equivalence for OsteoMed Wrist Plating system is based on similarities in intended use, design and operational principle to the referenced predicates. Based on the similarities, we believe that the OsteoMed Wrist Plating System does not raise any new safety or effectiveness issues." This is the core argument for a 510(k) submission.
Without a clinical study explicitly designed to measure performance against predefined acceptance criteria, it's impossible to populate the requested table and answer many of the questions.
§ 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.