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The Piccolo Composite Proximal Femur Nails are indicated for the treatment of stable and unstable proximal femur fractures (pertrochanteric, intertrochanteric high subtrochanteric fractures, and combinations of these fractures), including, fractures resulting from trauma, nonunions, pathological fractures, impending pathological fractures, tumor resections, and revision procedures.

The Piccolo Composite Nailing System includes nails, screws and a set of instruments.

The Piccolo Composite nail indicated for treatment of the proximal femur is a cylindrical rod. Nail mid-shaft diameter is 11mm, with the proximal end diameter of up to 17mm. Nail lengths are 180mm, 200mm, and in the range of 300 – 460mm. The nail provides for holes at the proximal and distal sections, designed for the insertion of a lag screw and interlocking screws. The lag screw is of 10.4mm diameter, with its length being in the range of 80mm to 110mm. The nails (and, optionally, the lag screws) are made of carbon fiber reinforced polymer and incorporate small amount of titanium/titanium alloy. Tantalum markers are embedded within the carbon fiber reinforced polymer, where applicable, to enable visualization during imaging. The distal screws, and, optionally, the lag screws, are made of titanium alloy.

The provided text describes a 510(k) premarket notification for a medical device, the Piccolo Composite® Nailing System, which is an intramedullary fixation rod. The document primarily focuses on demonstrating substantial equivalence to predicate devices. It does NOT contain information related to software or AI-driven devices, and therefore, does not discuss acceptance criteria, study methodologies, or performance results in the context of AI or machine learning.

The 510(k) summary (pages 3-5) highlights:

• Intended Use/Indications for Use: Treatment of stable and unstable proximal femur fractures.
• System Description: Includes nails, screws, and instruments made of carbon fiber reinforced polymer with titanium/titanium alloy components and tantalum markers.
• Substantial Equivalence: Claimed based on intended use, design, materials, technological characteristics, and principles of operation being similar to predicate devices.
• Performance Characteristics: Mentions "static and dynamic bending of implants construct" and "bacterial endotoxin testing" were conducted, and results were "comparable to those of predicate devices."

Therefore, I cannot provide the requested information regarding acceptance criteria, study design, or performance metrics for an AI/software device as the provided document pertains to a physical medical implant device and does not involve AI or software performance evaluation.

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