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The Medial Locking Plate is indicated for:
-Pilon Fractures: distal tibial intra-articular fractures
-High medial malleolar fractures
-Low boot type rotational distal extra-articular shaft fractures

while the Anterolateral Locking Plate is indicated for:
-Distal intra-articular tibia fractures
-Proximal tibia fractures
-Proximal and distal humerus fractures

Not Found

The provided text is a 510(k) summary for a medical device called the "Anterolateral and Medial Locking Plating System." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a new clinical study with specific acceptance criteria and performance metrics for a novel technology.

Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria, a study proving the device meets those criteria, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies for AI performance.

The key points from the document pertinent to its regulatory status are:

• Intended Use: The Medial Locking Plate is indicated for pilon fractures (distal tibial intra-articular), high medial malleolar fractures, and low boot type rotational distal extra-articular shaft fractures. The Anterolateral Locking Plate is indicated for distal intra-articular tibia fractures, proximal tibia fractures, and proximal and distal humerus fractures.
• Technological Characteristics: The technological characteristics are stated to be the "same as the predicate device including design and material."
• Substantial Equivalence: The submission asserts that the device is "substantially equivalent to the currently marketed DePuy devices" and that "No new issues of safety or efficacy have been raised."
• Predicate Devices: The document lists several DePuy devices as predicates: TiMax Medial Pilon Plate (K990120), TiMax Meta Plate (K983853), 3.5mm Cortical Bone Screws (K905048), and Cancellous Bone Screws (K882381).

In summary, there is no study described in this 510(k) summary that would provide acceptance criteria, reported device performance metrics, or the other detailed information requested about a study to prove a device meets acceptance criteria. This submission is based on demonstrating equivalence to existing devices, not on de novo performance testing against new criteria.

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