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The Craniotech Bone Transport Reconstruction Plate (BTRP) system includes devices intended as a bone stabilizer, lengthening and/or transport device when correction of congenital or developmental bone deficiencies or post-traumatic or post-surgical defects of the mandible (including ramus, body, alveolar ridge, symphisis) and mid-face bones require gradual distraction.

The device contains a reconstruction plate and screws of TiAl6V4 titanium alloy, and a stainless steel bone transport unit, activation screw and flexible cable.

The provided text is a 510(k) summary for a medical device called the Craniotech Bone Transport Reconstruction Plate (BTRP). It describes the device, its intended use, and its substantial equivalence to a predicate device.

*Crucially, this document does not contain any information regarding specific acceptance criteria, device performance metrics, or study details (like sample size, ground truth establishment, or expert qualifications) that would typically be found in a clinical or performance study report. The 510(k) summary is a regulatory document focused on demonstrating substantial equivalence, not a detailed performance study report.

Therefore, I cannot provide the requested information from the given text.

If this were a document about AI/ML device performance, the requested information would typically be present in a "Performance Data" or "Clinical Study" section of the 510(k) summary or a separate study report.

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