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

• · Diaphyseal, metaphyseal, extra- and intra-articular fractures
• · Non-unions, malunions, and deformities
• · Periprosthetic fractures
  The Pangea Utility Plating System is also indicated for children (2-12 years) and adolescents (12 - 21 years) for the internal fixation and stabilization of bone fractures of the diaphysis in which growth plates have fused or in which growth plates will not be crossed by implants.

The Pangea Platform is indicated for the internal fixation of bone fractures, osteotomies, and arthrodesis in normal and osteopenic bone, including:

• · Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures
• · Non-unions, malunions, and deformities
• · Periprosthetic fractures
  The Pangea Platform is also indicated for children (2-12 years) and adolescents (12 - 21 years) for the internal fixation and stabilization of bone fractures of the diaphysis and metaphysis in which growth plates have fused or in which growth plates will not be crossed by implants.

This Traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance to market the Pangea Utility Plating System and the Pangea Platform. This submission encompasses multiple systems (Pangea Utility Plating System and Pangea Platform) that have similar intended use and/or will be used together during the surgical procedure. The Pangea Utility Plating System consists of mini-, small-, and large-fragment plates manufactured from Ti6Al4V-ELI per ASTM F136. The plates range in length from 26 mm to 486 mm. The Pangea Platform consists of screws and cable plugs. The screws are offered as locking or non-locking variants. The locking screws are manufactured from CoCr and are available as Ø2.7 mm (L8 mm – 80 mm), Ø3.5 mm (L10 mm – 120mm), Ø4.0 mm (L14 mm – 95 mm), Ø5.0 mm (flat tip) (L10 mm – 20 mm), and Ø5.0 mm (L14 mm – 120 mm). The non-locking screw is manufactured from Titanium alloy (Ti6Al4V-ELI per ASTM F136) and is available in Ø2.7 mm (L6 mm – 80 mm). The cable plugs are made of Titanium alloy (Ti6Al4V-ELI per ASTM F136), and the T15 and T20 cable plugs are available for the 3.5mm locking mechanism. The Cancellous screws are available as Ø4.0 mm fully and partially threaded (L10-100 mm) and Ø6 mm 16mm thread (L30 -150 mm), Ø6 mm 32mm thread (L45 -150 mm) and fully threaded (L20-150 mm).

The provided document is a 510(k) summary for the Stryker GmbH Pangea Utility Plating System and Pangea Platform. It is a regulatory submission for medical devices (bone fixation systems) and does not contain information about an AI/ML-based device or a study involving human readers and AI assistance.

Therefore, I cannot extract the information required to describe the acceptance criteria and the study proving an AI/ML device meets them, as the document pertains to physical orthopedic implants, not software or AI.

The bulleted list in your request (acceptance criteria, sample size, expert ground truth, adjudication, MRMC study, standalone performance, ground truth type, training set size, training ground truth establishment) is highly relevant for evaluating AI/ML medical devices, but this document does not contain such details. It focuses on the mechanical and material equivalence of the Pangea systems to previously cleared predicate devices.

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