Search Results

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.

Ask a specific question about this device