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The Apex Femoral Nailing system is intended for temporary fixation of the fractures of the femur. The Apex nail is indicated for used in adult patients for treatment of:

• Open and closed fractures, including simple, severely comminuted, spiral, large oblique, and segmental fractures;
• Fractures involving osteopenic or osteoporotic bone;
• Fractures with bone loss;
• Pseudoarthosis, nonunion, and malunion;
• Correction osteotomy;
• Pathologic fractures and prophylactic nailing of impending pathologic fractures;
• Periprosthetic fractures;
• Closed supracondylar fractures (retrograde only) and:
• Intertrochanteric and subtrochanteric fractures (antegrade only)

The Apex Femoral Nailing system is a femoral intramedullary fixation system designed to be implanted and interlocked proximally and distally using bone screws or a provided surgical instrumentation kit. Like many of the currently-marketed intramedullary nails, the Apex Nail offers several different proximal and distal locking options from which the surgeon may choose, depending on the fracture. An insert within the proximal nail stem maintains the high torsional stability of static locking when the construct is locked in a dynamization mode. The Apex Femoral Nailing System include a femoral nail, bone screws, bolts and endcaps of varying sizes. All parts of the system are manufactured from Titanium 6AL4VELi. The Apex Femoral Nail, screw, bolt and endcap are available in varying lengths and diameters.

The provided text describes the regulatory clearance of a medical device, the Apex Femoral Nailing System, through a 510(k) submission. This document does not contain information about a study proving the device meets acceptance criteria related to an AI/ML-based medical device.

Instead, the document focuses on:

• Device Description: An intramedullary fixation system for femoral fractures.
• Intended Use/Indications for Use: Specific types of femoral fractures it's designed to treat in adult patients.
• Substantial Equivalence: The device is deemed substantially equivalent to a predicate device (Zimmer Natural Nail) based on similarities in intended use, technological characteristics, and performance data.
• Non-Clinical Performance Testing: It states that the device was tested in accordance with certain ASTM standards (F1264-16 and F543-07) and "all acceptance criteria were met," along with "Full Construct Testing" and "Bacterial Endotoxin Testing."
• Regulatory Clearance: The FDA's decision to clear the device for marketing.

Therefore, I cannot provide the requested information regarding AI/ML device performance, acceptance criteria tables, sample sizes for test/training sets, expert qualifications, or ground truth establishment because this document does not pertain to an AI/ML medical device or a study involving human readers or algorithm performance in that context.

The "acceptance criteria" mentioned in the document relate to the non-clinical performance testing of a physical medical device (like mechanical strength, material properties, sterility), not the performance metrics of an AI/ML algorithm.

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