(29 days)
Jet-X Bar External Fixation System components are intended to be used on adults or pediatric patients as required and are intended to be used for fracture fixation (open and closed); post-traumatic joint contracture which has resulted in loss of range of motion; fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction; pseudoarthrosis of long bones; limb lengthening by epiphyseal or metaphyseal distraction of bony or soft tissue deformity: correction of segmental bony or soft tissue defects; infected fractures or non-unions; joint arthrodesis; and management of comminuted intra-articular fractures of the distal radius.
Jet-X Bar Clamp and Pin Clamp - Non-magnetic/MR Safe components are for single use only.
External fixation devices, such as the Jet-X Bar Clamp and Pin Clamp - Non-Magnetic/MR Safe devices described herein, are specifically designed components to be used in the management of bone fractures and reconstructive, as well as corrective, orthopedic surgery. Devices include a Jet-X Bar-to-Bar Clamp -Non-magnetic/MR Safe; a Jet-X Bar-to-Pin Clamp - Non-magnetic/MR Safe; and a Jet-X Bar-to-Ring Clamp - Non-magnetic/MR Safe. The metal alloys used in their manufacture are chosen to address a wide range of applications. These devices have been designed to allow for the appropriate amount of rigidity and stability. The devices described herein are made from non-magnetic materials and are intended for use in the MR environment.
The provided text is a 510(k) summary for a medical device (Jet-X® Bar Clamps and Pin Clamps - Non-magnetic/MR Safe) and does not contain information about acceptance criteria and a study proving those criteria were met for an AI/ML powered device.
This document describes a traditional medical device (external fixation accessories) and focuses on its substantial equivalence to predicate devices, material composition, intended use, and regulatory classification. It does not involve any artificial intelligence, machine learning, or software-driven diagnostic or therapeutic functions that would require the evaluation of performance metrics such as accuracy, sensitivity, or specificity against established ground truth.
Therefore, I cannot fulfill the request to provide the detailed information listed in the prompt (acceptance criteria table, sample sizes, expert qualifications, etc.) as that information is not present in the provided text.
§ 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.