(90 days)
The Stratum Ankle Fusion Plating System is indicated for use in stabilization of fractures or osteotomies, intra and extra articular fractures, and multi-fragmentary fractures, non-union and malunion, joint fusion and reconstruction of small bones of the feet and ankles including the distal tibia, talus, and calcaneus.
The Stratum Ankle Fusion Plating System is a foot and ankle plating system consisting of plates and screw implants. The plates are 3.5mm thick, range in length from 73.66mm to 107.70mm, and range in width from 22.10mm to 40.64mm. The plates have between 10 and 13 locking screw holes and 1 to 2 slots. The plates are provided sterile. The system provides locking and nonlocking screws that are available in diameters of 3.5mm and range in length from 10mm to 80mm. The screws are provided sterile and non-sterile. The system includes cannulated crossing screws that are 6.5mm in diameter and range from 26mm to 90mm in length. The cannulated screws are provided sterile. The plates and screws are manufactured from Ti-6Al-4V ELI conforming to ASTM F136.
The system is provided with a set of accessory instruments designed for preparation of the implant site and insertion of the implants into bone.
This document is lacking the essential information requested in the prompt, such as acceptance criteria, reported device performance metrics (e.g., sensitivity, specificity, accuracy, AUC), sample sizes for test and training sets, details on expert ground truth establishment, adjudication methods, and explicit mention of standalone or MRMC studies.
The provided text describes a 510(k) premarket notification for a medical device called the "Stratum Ankle Fusion Plating System." This is a metallic bone fixation appliance, and the FDA has determined it is substantially equivalent to legally marketed predicate devices. The document focuses on regulatory compliance, device description, indications for use, and non-clinical testing to demonstrate mechanical equivalence. It explicitly states that clinical testing was not necessary for substantial equivalence.
Therefore, I cannot fulfill the request as the provided text does not contain the required information about acceptance criteria, performance studies (clinical or AI-related), sample sizes, expert ground truth, or adjudication methods. The device is a physical bone fixation system, not a software or AI-based diagnostic device that would typically undergo such performance 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.