(45 days)
Merete® CS, Cortical Screws 3.0 and 3.5mm can be used for adult and pediatric patients. Indications for use include fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hands, feet, wrists, ankles, fingers and toes.
Not Found
The provided document is an FDA 510(k) clearance letter for a medical device (Merete® CS, Cortical Screw 3.0 and 3.5mm) and does not contain information about acceptance criteria or a study proving the device meets acceptance criteria as described in the prompt.
The letter confirms that the device is substantially equivalent to legally marketed predicate devices, meaning it has similar indications for use, technological characteristics, and performance. However, it does not include a detailed report of a study with specific acceptance criteria, sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot answer the questions based on the provided input.
§ 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.