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The Periarticular Locking Plate System is indicated for temporary internal fixation and stabilization of osteotomies and fractures, including:

• Comminuted fractures. .
• . Supracondylar fractures,
• . Intra-articular and extra-articular condylar fractures,
• . Fractures in osteopenic bone,
• . Nonunions, and
• . Malunions

The Zimmer Periarticular Locking Plate System is a plate and screw system. The low-profile periarticular plates are anatomically contoured with threaded holes to engage and "lock" the screws at a fixed angle relative to the plate.

The provided text does not contain information about the acceptance criteria or a study proving that a device (specifically, an AI/analytic model) meets those criteria. The document is a 510(k) summary for the Zimmer Periarticular Locking Plate System, which is a physical medical device (a plate and screw system for bone fixation).

The document discusses:

• Device Description: A plate and screw system for bone fixation.
• Intended Use: Temporary internal fixation and stabilization of osteotomies and fractures.
• Comparison to Predicate Device: The submission is to add a sterile version of existing non-sterile devices.
• Performance Data (Nonclinical):
  • Sterilization Validation (terminal sterilization to SAL greater than or equal to 10-6 at 20kGy gamma dose).
  • Shelf Life (10 years, based on accelerated aging).
  • Sterile Packaging (to withstand normal distribution and storage and maintain sterile barrier).
• Clinical Data: Stated that "Clinical data and conclusions were not needed for this device."

Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI/analytic model, as the document is about a hardware device and does not involve AI or analytical performance testing with ground truth, expert review, or statistical measures like sample size, effect size, etc.

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