(94 days)
The Nextremity Solutions Stratum™ Foot Plating System is a plate and screws construct indicated for fixation of fractures, osteotomies, non-unions and fusions of small bones and small bone segments, particularly in osteopenic bone.
The Stratum™ Foot Plating System is a foot and ankle plating system consisting of plate and screw implants. The plates range in length from 26mm to 81.5mm and in width from 8.5mm to 29mm and feature between 2 and 10 screw holes. There are 6 different styles of screws; 2 diameters of nonlocking screw, 3 diameters of fixed angle locking screws and 1 diameter of multi-directional locking screw. The screws range in length from 10mm to 70mm. Screws are available in sterile and non-sterile versions. The system also includes a sterile set of accessory instruments and individually packaged drill guides / drill bits designed for preparation of the implant site and insertion of devices into the bone. The plates, sterile screws, instrument kits, and drill guide / drill bits are all packaged individually in separate sterile packaging. The non-sterile screws are provided in a case and tray suitable for steam sterilization. The plates, non-locking and locking screws are manufactured from Ti-6Al-4V ELI conforming to ASTM F136. The multi-directional locking screws are manufactured from Co-Cr-Mo conforming to ASTM F75.
The provided text primarily details a 510(k) premarket notification for a medical device (Stratum™ Foot Plating System) and does not describe an AI/ML powered device, nor does it contain information regarding acceptance criteria, device performance metrics, or study details relevant to AI/ML device evaluation.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies for an AI/ML device from this document.
The document indicates that clinical testing was not necessary for the substantial equivalence determination of the Stratum™ Foot Plating System. The evaluation was based on non-clinical testing (mechanical strength, bacterial endotoxin testing) to demonstrate substantial equivalence to predicate devices, which is typical for Class II devices like this one.
§ 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.