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The Stryker Leibinger NewGen System is a mandibular plate and screw system intended for stabilization and rigid fixation of mandibular fractures and mandibular reconstruction.

NewGen/Universal Mandibular System

The provided text is a 510(k) summary for the "NewGen/Universal Mandibular System," a bone plate and screw system for mandibular fixation. It does not contain any information about acceptance criteria, device performance, or a study to prove it meets acceptance criteria.

The document is a regulatory submission for premarket notification, aiming to demonstrate substantial equivalence to previously marketed devices. It confirms the device's intended use and regulatory classification but does not detail performance metrics or clinical study results as would be expected for an AI/ML or diagnostic device.

Therefore, I cannot provide the requested information. The text does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for test sets.
3. Number or qualifications of experts for ground truth establishment.
4. Adjudication methods.
5. MRMC comparative effectiveness study results.
6. Standalone performance study details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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