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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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The Growth Control Plating System is designed for redirecting the angle of growth of long bone(s) in pediatric patients. 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); valqus, 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 Growth Control Plating System consists of plates and screws, all of which are comprised of Ti-6Al-4V.

The provided text describes a 510(k) premarket notification for the "Growth Control Plating System." This document is focused on establishing substantial equivalence to a predicate device based on technological characteristics and non-clinical testing. It explicitly states that no clinical testing was performed or provided as a basis for substantial equivalence.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, nor can I provide information on sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, specific types of ground truth, or training set details.

The document indicates:

• Clinical Testing: None provided as a basis for substantial equivalence.

This means that the information you are requesting regarding "acceptance criteria" based on clinical performance and a "study that proves the device meets the acceptance criteria" is not present in the provided 510(k) summary. The device's clearance was based on demonstrating "substantial equivalence" through non-clinical testing and technological comparisons to a legally marketed predicate device (Guided Growth Plate K031493 University of Utah School of Medicine).

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