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Pangea Femur Plating System:
The Pangea Femur Plating System is indicated for the internal fixation of femur bone fractures and osteotomies in normal and osteopenic bone, including:

• · Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures
• · Non-unions, malunions and deformities
• · Periprosthetic fractures

Pangea Fibula Plating System:
The Pangea Fibula Plating System is indicated for the internal fixation of fibula bone fractures and osteotomies in normal and osteopenic bone, including:

• · Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures
• · Non-unions, malunions, and deformities
• · Periprosthetic fractures

Pangea Tibia Plating System:
The Pangea Tibia Plating System is indicated for the internal fixation of tibia bone fractures and osteotomies in normal and osteopenic bone, including:

• · Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures
• · Non-unions, malunions, and deformities
• · Periprosthetic fractures

Pangea Humerus Plating System:
The Pangea Humerus Plating System is indicated for the internal fixation of humerus bone fractures and osteotomies in normal and osteopenic bone, including:

• · Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures
  · Non-unions, malunions, and deformities
• · Periprosthetic fractures

This traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance to market the Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, and Pangea Humerus Plating System. This submission encompasses multiple systems that have similar intended use. All plates are manufactured from Ti6Al4V ELI (ASTM F136), are anatomically pre-contoured. and are available in different sizes and left/right versions. The plates are provided sterile or non-sterile and range in length from 68 mm to 441 mm. The plates allow for the use of locking and non-locking screws and are used with cable plugs and washers.

The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. Instead, it is an FDA 510(k) clearance letter for the Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, and Pangea Humerus Plating System.

The letter indicates that clinical testing was not required for this submission, and therefore, there are no details regarding sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment.

The document discusses non-clinical testing performed to support substantial equivalence, including:

• Dynamic construct testing
• Magnetic Resonance (MR) compatibility assessments:
  • Magnetically Induced Displacement per ASTM F2052
  • Magnetically Induced Torque per ASTM F2213
  • Image Artifacts per ASTM F2119
  • RF Heating per ASTM F2182

These tests are typically performed to ensure the physical and mechanical properties of the device and its compatibility with imaging environments, rather than evaluating performance for diagnostic or clinical decision-making.

Therefore, I cannot populate the requested table and information based on the provided text.

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