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Intended Use: The DePuy POLYAX Locked Plating System is intended to be implanted for the fixation of bone fractures and osteotomies, implanted either percutaneously or by a tre divinoval open method.

Indications for Use: The POLYAXTM Locked Plating System is intended for use in cases requiring stabilization of malunions, non-unions, and osteotomies of the distal femur and proximal tibia and Open Reduction Internal Fixation (ORIF) repair of closed and open fractures of the distal femur and proximal tibia including, but not limited to the following: periarticular fractures, such as simple comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression fractures with associated shaft fractures, and periprosthetic fractures.

The DePuy POLYAX Locked Plating System is comprised of anatomically contoured, multi-hole fracture plates and screws. The plates allow for polyaxial screw locking, with, provisions for fixed angle locking, variable angle locking and non-locking, vriw construct options.

The provided text is a 510(k) summary for the DePuy POLYAX™ Locked Plating System, a bone fixation device. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria or a study proving the device meets those criteria, as typically seen with performance data for AI/ML devices.

This particular 510(k) summary is for a traditional medical device (a bone fixation system) and thus the regulatory pathway relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing performance data against specific acceptance criteria from a clinical or AI performance study.

Therefore, I cannot populate the requested table or answer the questions related to studies, sample sizes, ground truth, or expert involvement because this information is not present in the provided text. The submission focuses on:

• Device Description: Multi-hole fracture plates and screws allowing polyaxial screw locking.
• Intended Use/Indications: Fixation of bone fractures and osteotomies of the distal femur and proximal tibia (malunions, non-unions, osteotomies, ORIF of closed/open fractures including periarticular and periprosthetic fractures).
• Basis of Substantial Equivalence: Similarity in intended use, indications for use, materials, and design to the DePuy POLYAX Knee Fracture System (K003235) and Zimmer Periarticular Locking Plates (K040593).

There are no details of a study with acceptance criteria, performance metrics, sample sizes, ground truth, or expert evaluations as would be expected for a software or AI/ML device.

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