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The Flow-Nail is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric, intertrochanteric, and high subtrochanteric fractures and combinations of these fractures. The Flow-Nail can also be used to deliver injectable bone void fillers to a surgical site.

The Flow-Nail is a dynamic compression trochanteric nail system and includes an intramedullary nail, a fenestrated lag screw, anti-rotation screw, cortical screws, a cap and accompanying surgical instruments. The Flow-Nail components are made of titanium alloy (Ti-6Al-4V) conforming to ASTM F136. The purpose of this Special 510(k) is to add Flow-Nail with Laglock to the Flow-Nail System. The components are provided non-sterile, for single use, by prescription only.

This document concerns a medical device called "Flow-Nail," an intramedullary fixation rod, and an addition to the system called "Flow-Nail with Laglock." The submission is for a 510(k) premarket notification, which is a process to demonstrate that a device is substantially equivalent to a predicate device already legally marketed.

The document does not contain information about the performance or acceptance criteria of an Artificial Intelligence (AI) / Machine Learning (ML) enabled medical device. The testing described is non-clinical performance data for an implantable orthopedic device, specifically mechanical strength tests (Compression Bending Strength Dynamic and Static per ASTM F384).

Therefore, I cannot provide the requested information regarding the acceptance criteria and study proving an AI/ML device meets these criteria, as the provided text pertains to a traditional mechanical medical device, not an AI/ML device.

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