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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); posttraumatic 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; correction 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 intraarticular fractures of the distal radius.

Jet-X Bar System Clamps, Bars and Posts – MR Conditional components are for single use only.

External fixation devices, such as the Jet-X® Bar System Clamps, Bars and Posts – MR Conditional 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 Jet-X System Clamps, Bars, and Posts. The materials 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.

This document is a 510(k) summary for the Jet-X® Bar System Clamps, Bars and Posts – MR Conditional, an external fixation device. It asserts substantial equivalence to predicate devices and focuses on the MR Conditional aspect. As such, it does not describe a study involving device performance against acceptance criteria in the way a clinical or AI-based diagnostic device submission would.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, or adjudication methods from the provided text. The document primarily addresses regulatory aspects of substantial equivalence based on material properties and intended use for an orthopedic device, not a performance study measuring sensitivity, specificity, or similar metrics typically associated with acceptance criteria in an AI/diagnostic context.

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