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The Hinge Pediatric Plating System is indicated as a temporary implant to aid in the correction of the angle of growth of long bones by inhibiting longitudinal growth of the physis in pediatric patients. It can be used to correct the following conditions:

• Femur and tibia: varus, valgus, flexion or extension deformities of the knee. .
• . Humerus: valgus or varus deformities of the elbow.
• Radius and Ulna: flexion or extension deformities of the wrist. .
• Ankle: varus, valgus or plantar flexion deformities of the ankle. .

The Hinge Pediatric Plating System is a three-component device made of Medical Grade Stainless Steel. The components are a plate and two screws of different sizes.

This document describes the Hinge Pediatric Plating System, a medical device for correcting angular deformities in pediatric patients' long bones. The provided text indicates that the submission is a 510(k) summary, aiming to establish substantial equivalence to previously marketed predicate devices.

Based on the provided text, there is no information related to a study that establishes acceptance criteria for an AI/algorithm-based device, nor is there any device performance data in the context of AI. The entire document focuses on the regulatory submission for a physical medical device (pediatric bone plates and screws) and its substantial equivalence to existing predicate devices based on design, function, and biomechanical testing.

Therefore, I cannot populate the requested table or answer the subsequent questions, as they are not applicable to the provided content. The document explicitly states:

"Clinical Testing: No clinical testing was provided as a basis for substantial equivalence."

This further confirms that no clinical studies, which would typically involve human subjects and generate performance data against acceptance criteria, were provided for this submission. The "Biomechanical Testing" mentioned refers to physical tests on the device itself, not performance in a clinical or AI context.

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