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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 the 10mm IM Nail to the Flow-Nail System. The IM Nail (10mm) is manufactured from Ti-6Al-4V per ASTM F136. The components are provided non-sterile, for single use, by prescription only.

The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device called "Flow-Nail." It contains information about the device's classification, indications for use, and a summary of the 510(k) submission, including predication and performance testing.

However, the document does not contain any information about an AI-powered device or a study involving acceptance criteria, ground truth, expert readers, or multi-reader multi-case (MRMC) comparative effectiveness studies. The performance testing mentioned is mechanical testing (compression bending strength) per ASTM standards for an intramedullary fixation rod, not an AI or imaging device.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the necessary information is absent from the provided text.

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