(132 days)
The NBXTM Non-Bridging External Fixator - Shoulder, is used for external fixation, until healing. This device is used for the fixation of open or closed fractures, mal-union, and non-union of the proximal end of the humerus to include sub-capital and/or fractures of the humeral head.
The NBXTM Non-Bridging Fixator – Shoulder is provided sterile. The fixator consists of the body and with its proprietary locking mechanism and a multiple of threaded pins.
This document is a 510(k) summary for the NBX™ Non-Bridging External Fixator - Shoulder. It does not describe an AI/ML device or software. Therefore, the questions related to acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, or multi-reader multi-case studies, which are typically associated with performance evaluation of AI/ML software, are not applicable to this submission.
The document discusses a traditional medical device (an external fixator) and its substantial equivalence to previously marketed devices. The performance data mentioned ("Non-Clinical performance data: Equivalence to accepted methods of treatment for this products indication of use is covered in other sections of this application") refers to engineering and biocompatibility testing, not clinical studies involving AI performance metrics.
§ 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.