(269 days)
The Exactech® Equinoxe® PHx® Fracture System is indicated for Open Reduction Internal Fixation (ORIF) procedures of the proximal humerus. Specific clinical indications for ORIF are as follows: fractures, fracture dislocations, osteotomies, and non-unions of the proximal humerus.
The 3.5mm diameter Exactech® EPIC Screws of the Epic Extremity Plate System (cleared under K153340) are also intended for use with the Exactech® Equinoxe® PHx® Fracture System for Open Reduction Internal Fixation procedures of the proximal humerus.
The Exactech® Equinoxe® PHx® Fracture System is a set of plate and screw components for use in Open Reduction Internal Fixation (ORIF) applications for fractures of the proximal humerus. The Exacteche Equinoxe® PHx® Fracture System includes various sizes of fracture plates and fixation screws and is to be used with the 3.5mm diameter Exactech® EPIC locking and non-locking style screws (cleared under K153340). The Exactech® Equinoxe® PHx® Fracture System with the Exactech® EPIC Screws are intended to be used for internal fixation of fractures, fracture dislocations, non-unions, and osteotomies of the proximal humerus.
The Exactech® EPIC Screws were previously cleared with the Epic Extremity Plate System with an indication for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. This is an indication change only for the 3.5mm EPIC locking and non-locking screws.
This 510(k) summary describes a medical device, the Exactech® Equinoxe® PHx® Fracture System with Exactech® EPIC Screws, and its substantial equivalence to predicate devices, but it does not include information about acceptance criteria and a study proving device meets acceptance criteria in the way typically expected for an AI/software as a medical device (SaMD) submission.
This document is for a physical orthopedic implant (plate and screw system for bone fixation), not an AI or software device. The "performance criteria" and "testing" described are for mechanical and biocompatibility aspects of the physical hardware, not for diagnostic accuracy, sensitivity, specificity, or other performance metrics usually associated with AI/SaMD.
Therefore, I cannot provide the requested information in the format specific to AI/SaMD for this document. The concepts of "test set," "training set," "ground truth," "experts for ground truth," "adjudication method," and "MRMC comparative effectiveness study" are not applicable to the information provided in this 510(k) summary for a physical orthopedic device.
If you have a document related to an AI/SaMD, I would be happy to analyze it for the requested information.
§ 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.