Search Results

The system is intended for use in internal fixation of small bones including the hand, foot, and craniomaxillofacial skeleton.

The Profyle Hand and Small Fragment System is a series of titanium plates and screws with plates of varying lengths and thicknesses and configurations including straight, L, T, Y. Z. rectangular, and condylar head options. These plates are attached to bone using 1.2-2.7 mm diameter titanium bone screws; screw diameter is dependent upon plate thickness. All screws are fully threaded and selftapping with cross-slotted heads.

This is a 510(k) summary for a medical device called the "Profyle™ Hand and Small Fragment System", which is a small bone plating system. This document is a pre-market notification to the FDA to demonstrate that the device is substantially equivalent to existing legally marketed devices.

Based on the provided text, there is no information about acceptance criteria, device performance studies, sample sizes, expert ground truth, or any form of AI/algorithm-related studies.

The document focuses on:

• Device identification: Proprietary name, common name, classification, regulatory class, product code.
• Device description: Materials (titanium plates and screws), configurations (various plate shapes and sizes), intended use (internal fixation of small bones in hand, foot, craniomaxillofacial skeleton).
• Substantial equivalence claim: Comparison to previously marketed predicate devices (Lunn Fixation System, Synthes Small Fragment and Mini Set, Wurzburg Titanium Mini Bone Plates and Screws) based on intended use, design, materials, and operating principles.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or AI-related metrics as this information is not present in the provided 510(k) summary.

The type of studies and data you are asking for (e.g., performance metrics, expert adjudication, AI impact) are typically associated with clinical trials or performance evaluation studies, which are not detailed in this particular 510(k) summary focused on substantial equivalence.

Ask a specific question about this device