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The Titanium Pediatric Femoral Nail is indicated for fractures of the femur including: non-comminuted and comminuted mid-shaft fracture, combination fractures of the shaft and neck, intertrochanteric fracture, combination intertrochanteric and subtrochanteric fractures.

Intramedullary rods (nails) are generally rod-shaped devices, with or without screw holes at either end for fixation to bone. This device is intended to be inserted into the medullary (bone marrow) canal of the femur for fixation of fractures by aligning and stabilizing the bone fragments. Additional stabilization may be realized by installing transverse screws through holes in the rod. This device is made of titanium 6AL-4V alloy.

This document is a 510(k) premarket notification for a medical device (Titanium Pediatric Femoral Nail) and does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

The purpose of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, not to prove clinical safety and effectiveness through a new clinical trial with specific performance metrics.

Therefore, I cannot extract the requested information from the provided text, as it doesn't exist within this document. The document primarily focuses on:

• Device Description: What the device is and its intended use.
• Potential Risks: General risks associated with this type of device.
• Substantial Equivalence Argument: How this device is similar to previously cleared devices (stainless steel rods and other titanium intramedullary rods).
• FDA Clearance Letter: Formal statement from the FDA that the device is substantially equivalent and can be marketed.
• Indications for Use: The specific medical conditions for which the device is intended.

To answer your questions, one would typically look for a clinical study report or a different type of regulatory submission (like a PMA, which requires clinical data to demonstrate safety and effectiveness).

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