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The Small Fragment System consists of bone plates and screws to be used for stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers, toes, and craniomaxillofacial skeleton.

The Lorenz Small Fragment System is comprised of a variety of titanium plates and screws with shapes and sizes designed for internal fixation of small bones. The screws will have both cross drive and center drive head features and be 1.2mm - 2.7mm in diameter. The plates will include straight, rectangle, parallelogram, trapezoid, T, L, Y, Z, and condylar pin options with various lengths and thicknesses.

This document is a 510(k) summary for the Lorenz Small Fragment System, a medical device. It describes the device, its intended use, and potential adverse effects. It also includes the FDA's clearance letter, stating the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information regarding acceptance criteria, device performance metrics, or any study details that would prove a device meets acceptance criteria.

Therefore, I cannot fulfill your request for the specific points about acceptance criteria and a study demonstrating compliance. The submission document focuses on regulatory clearance based on substantial equivalence, not on a detailed performance study with specific metrics.

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