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The Extremity Medical External Fixation System is indicated for adults and pediatric patients (2 years old and older) for treatment of:
Open and closed fractures
Osteotomies
Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
Pseudoarthrosis, infected union, non-union, or malunion of long bones
Limb lengthening by epiphyseal, diaphyseal, or metaphyseal distraction
Correction of bony or soft tissue deformity (orthoplastic surgery)
Joint arthrodesis
Infected fractures
Correction of segmental bony or soft tissue defects
Management of comminuted intra-articular fractures
Bone transport
Revision procedures where other treatments or devices have been unsuccessful
Bone reconstruction procedures
Charcot foot reconstruction
Offloading and/or immobilization of ulcers and/or wounds of the foot and ankle
Ankle distraction (arthrodiastasis)
Septic fusion

The Extremity Medical External Fixation System consists of three basic types of elements: bridge elements, connection elements and bone anchorage elements. The system is intended for use in a variety of applications including but not limited to Charcot foot reconstruction, open fracture fixation, joint arthrodesis, limb lengthening and bone transport. The assembly is made up of two or more circular rings that are connected by struts, rods or pillars to provide a framework for fixation. Pins and tensioned wires are then used to fixate and stabilize bones and joints.

Bridge elements include rings, manufactured from anodized aluminum, in various types and sizes to accommodate varying patient anatomy. Connection elements, manufactured from stainless steel and anodized aluminum, include threaded rods and threaded pillars available in multiple lengths and struts available in multiple sizes. Bone anchorage elements include wires and half pins, manufactured from stainless steel, available in multiple diameters and lengths.

All External Fixation components are for single use only.

The original document is a 510(k) summary for the Extremity Medical External Fixation System. It describes a medical device, its indications for use, and a comparison to predicate devices, focusing on non-clinical testing for substantial equivalence.

It does not contain information about acceptance criteria or a study proving that an AI/Software as a Medical Device (SaMD) meets acceptance criteria. The document focuses on the substantial equivalence of a physical external fixation system through engineering analysis and static/dynamic construct testing, not on the performance of a software algorithm.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI/SaMD from this document. The sections you asked about, such as sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, are not relevant to the content of this 510(k) summary for a physical medical device.

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