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The KLS Martin Hand Distractor is designed to be used in finger reconstruction of the thumb or the metacarpal bones I - IV after amputation or malformation.

The KLS Martin Hand Distractor is a subcutaneous bone distractor. It features two telescoping jackscrew components activated by, fixed to the bone with plates and secured with titanium bone screws.

The provided text is a 510(k) summary for the KLS-Martin Hand Distractor. It describes the device, its intended use, technological characteristics, and its substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert evaluations.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria using the provided input. The document is solely focused on demonstrating substantial equivalence to existing legally marketed devices, which is a regulatory pathway that often relies on comparison to predicate devices rather than new performance studies.

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