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The FEP and Stylo external fixation systems, are modular systems with the components of: joints, bars, clamps or screws. Such components, with various assemblies, form a device indicated for reconstruction and corrections of bone segments of the human body.

The FEP and Stylo external fixation systems, are modular systems with the components of: joints, bars, clamps or screws. Such components, with various assemblies, form a device indicated for reconstruction and corrections of bone segments of the human body. All components are made of either Aluminum alloy 7012 or Stainless steel, AISI 316LVM, ISO 5831-1/9.

The provided text does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance metrics.

The document is a 510(k) premarket notification summary and a clearance letter for the "FEP and Stylo" external fixation systems. It focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics, design, and materials, rather than presenting a performance study with acceptance criteria.

Therefore, I cannot extract the requested information from the given text.

To address your request, the document would need to include sections detailing:

• Specific performance objectives for the device (e.g., strength, durability, biocompatibility).
• Test methods used to evaluate these objectives.
• Results of such tests compared against predefined acceptance criteria.
• Details about any clinical or technical studies conducted (sample sizes, ground truth establishment, expert qualifications, etc.).

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