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The agp APS System is intended for use of fractures of femoral head (Hip Plates) and condylar part of the femur (Condylar Plates).

Specific indications, which are dependent in the angle of the plate, include:

• 125°-150°: fractures of the trochanter region, simple and multifragmentary pertrochanteric, intertrochanteric
• 95°: distal and intercondylar fractures of the femur

The implants for the aap APS System are manufactured of Titanium Alloy and Stainless Steel and are available for the femoral head and the condylar part of the femur. The titanium alloy and the stainless steel material is identical to the materials used in the predicate devices.

The aap System includes APS Plates with various angles (95° for condylar plates; 125°, 130°, 135°, 140°, 145° and 150° for Hip Plates), APS Lag Screws with various lengths from 50mm to 145mm, APS compression screws and instruments for implantation.

The provided text describes a 510(k) summary for the "APS-System," an autodynamic plate-screw system intended for bone fixation. However, the document does not contain information regarding the acceptance criteria, device performance, or any studies conducted to prove the device meets performance criteria.

The information provided only covers:

• Submitter and contact details
• Trade Name and Common/Usual Name
• Classification information
• Performance standards related to manufacturing (cGMP, ASTM, ISO) and material specifications (Titanium Alloy, 316L Stainless Steel, surgical grade Stainless Steel, Silicone, Propylux, Polyoxymethylene).
• Intended Use and Contraindications
• Device Description
• Predicate Devices for Substantial Equivalence
• Sterilization Information
• FDA regulatory correspondence (510(k) clearance letter and Indications for Use statement)

Therefore, I cannot extract any of the requested information about acceptance criteria or studies from the provided text.

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