(29 days)
The NCB Plating System is indicated for temporary internal fixation of fractures and osteotomies of long bones.
The NCB Plating System is an extramedullary internal fixation plate system to be used for either distal femoral or proximal tibia fractures. It is intended to be implanted either percutaneously or by a traditional open method.
The provided text is a 510(k) summary for the Zimmer GmbH NCB® Plating System. This document describes a medical device, specifically a bone fixation system, and its premarket notification to the FDA.
Based on the content of the document, the device described is a mechanical implant, not an AI/software-based medical device. The "Performance Data (Nonclinical and/or Clinical)" section explicitly states:
- Non-Clinical Performance and Conclusions: "Class II: Amendment of Design Controls with verification of mechanical integrity and resistance."
- Clinical Performance and Conclusions: "Clinical data and conclusions were not needed for this device."
This means the clearance for this device was based on mechanical testing and verification of design controls, not on a study proving performance against acceptance criteria for an AI or software algorithm. There is no mention of an algorithm, AI assistance, human readers, or ground truth establishment in the context of device performance.
Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria and study details for an AI/software device, as this document is about a physical orthopedic implant.
§ 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.