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The Synthes Distraction Osteogenesis System, MR Conditional is intended for fracture fixation (open and closed), pseudoarthrosis or non-unions of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformities and correction of segmental bony or soft tissue defects in adult and pediatric patients.

The Synthes Distraction Osteogenesis System, MR Conditional with Expanded Indications is an external ring fixation system. The system is comprised of wires and Schanz screws that are attached to rings with bolts, nuts and/or clamps; rods that interconnect the rings; and connecting plates, hinges, standoffs, posts, supports and distractors that complete the assembly of the fixator. This system is a versatile system that is fully customizable. An individualized frame should be constructed for each case to suit the specific situation. The materials of construction for this system include implant grade titanium, elgiloy, stainless steel and carbon fiber.

This document is a 510(k) summary for the Synthes Distraction Osteogenesis System, MR Conditional with Expanded Indications. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, this document does not contain a study that proves the device meets specific acceptance criteria in the way a clinical trial or performance study for an AI/CADe device would.

The document focuses on demonstrating substantial equivalence for a physical medical device (an external fixation system), primarily based on:

1. Material similarity
2. Design similarity
3. Similar fundamental product technology
4. MR testing against ASTM and IEC standards
5. Engineering performance evaluation and analysis

Therefore, I cannot provide the detailed acceptance criteria and study information requested in your prompt because this type of information is not present in the provided text. The prompt's questions (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size) are typically relevant for evaluating software as a medical device (SaMD) or AI/CADe devices, which require studies to demonstrate diagnostic or predictive performance.

The provided text is for a hardware device where "acceptance criteria" are met through adherence to established material, manufacturing, and performance standards, and comparison to legally marketed predicate devices, rather than through a study with a predefined test set and ground truth in the context of diagnostic accuracy.

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