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The TC Plating System is intended for essentially non load-bearing stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis, and craniomaxillofacial skeleton.

The TC Plating System is comprised of a variety of titanium plates with shapes and sizes designed for internal fixation of small bone fragments. The plates include straight, right, and left configurations. The system also includes bone screws. Manual surgical instruments are supplied with the system to facilitate implantation.

The provided text is a 510(k) summary for the TC Plating System. This document is a regulatory submission for a medical device that demonstrates substantial equivalence to a legally marketed predicate device. It does not contain information about acceptance criteria, device performance studies, or clinical trial data.

The 510(k) summary explicitly states:

• Comparison of the technological characteristics of the device to predicate and legally marketed devices: 6. The TC Plating System is equivalent to the predicate devices in terms of:
  • Have the same indications for use and intended use.
  • Have the same basic shape/design.
  • Use the same operating principle.
  • Utilize the same materials.

This indicates that the submission relies on the established safety and effectiveness of predicate devices, rather than presenting new performance data from a specific study. Manufacturers of Class II devices (like the TC Plating System) can demonstrate substantial equivalence by showing that their device is as safe and effective as a legally marketed predicate device and does not raise different questions of safety and effectiveness. This often involves demonstrating similar technological characteristics and intended use, rather than conducting new clinical performance studies with acceptance criteria.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies because this information is not present in the provided text. The document focuses on regulatory equivalence rather than clinical performance study results.

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