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The KLS-Martin Rigid External Distraction (RED) device is utilized for the purpose of maxillary and midface osteodistraction in the reconstruction of patients with congenital and acquired craniofacial anomalies.

KLS-Martin Rigid External Distraction Device

The provided document is a 510(k) premarket notification approval letter for the KLS-Martin Rigid External Distraction (RED) device. This type of document confirms that the device is substantially equivalent to a predicate device already on the market and does not contain information about specific acceptance criteria, device performance studies, or details regarding the test set, training set, or ground truth establishment.

A 510(k) submission generally focuses on demonstrating substantial equivalence, often through comparisons of technological characteristics and intended use, rather than extensive clinical trial data or detailed performance studies with acceptance criteria as would be found in a Premarket Approval (PMA) application or a more detailed technical report.

Therefore, I cannot provide the requested information based on the content of this document. The document primarily serves as an FDA approval for market clearance.

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