(64 days)
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.).
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.