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The Peanut™ Growth Control Plating System is designed for redirecting the angle of growth of long bone(s) in pediatric patients (patients who have not had physeal closure/reached skeletal maturity). This is useful for gradually correcting angular deformities in pediatric patients with an open physis. Specific conditions/diseases for which the device will be indicated include valgus, varus, or flexion extension deformities of the knee (femur and/or tibia); valgus, varus or plantar flexion deformities of the ankle, valgus or varus deformities of the elbow, as well as radial or ulnar deviation, flexion or extension deformities of the wrist (radius).

The Peanut™ Growth Control Plating System consists of two plate designs (arched and stepped) and solid and cannulated screws.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance in the context of a medical device such as the Peanut™ Growth Control Plating System. The document is a 510(k) premarket notification for a medical device submitted to the FDA and focuses on demonstrating substantial equivalence to previously cleared devices rather than providing performance data against specific acceptance criteria.

The submission primarily discusses:

• Device Description: The components of the Peanut™ Growth Control Plating System.
• Indications for Use: The medical conditions and patient population for which the device is intended.
• Purpose of Submission: The specific modifications being made (adding screw lengths, adding a contraindication, offering non-sterile configurations).
• Contraindications: Conditions under which the device should not be used.
• Summary of Technologies: Stating similarity to legally marketed predicate devices.
• Substantial Equivalence: Arguing that the modifications do not raise new safety or effectiveness issues and that the device is equivalent to existing cleared devices (K070823 and K031493).
• Evidence for Substantial Equivalence: Mentions "Pull-out strength testing was provided to support substantial equivalence," but no details about the acceptance criteria, study design, or results are included in this summary.

Therefore, I cannot fulfill your request for the specific details about acceptance criteria, study design, sample sizes, expert qualifications, adjudication methods, or ground truth establishment as this information is not present in the provided text.

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