(22 days)
The Tyber Medical MST Trauma Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. Screws are intended for single use only.
General trauma screw for compression and fixation of bone with modified surface treatment (MST). The screws will be provided sterile in both solid and cannulated form, made of from titanium.
The provided text describes the regulatory clearance of a medical device (Tyber Medical MST Trauma Screw) and includes a summary of nonclinical testing. However, it does not contain information relevant to AI/ML device performance, such as acceptance criteria for algorithms, sample sizes for AI training/test sets, expert adjudication methods, or MRMC studies.
Therefore, I cannot provide a response that includes items 1-9 as requested, as these pertain specifically to AI/ML device evaluations which are not present in this document.
The document primarily focuses on demonstrating substantial equivalence to a predicate device through nonclinical testing, materials, and indications for use.
§ 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.