(101 days)
The SCARF THREAD-HEAD™ SCREW is intended to be implanted for fixation of bone fractures or bone reconstructions. The SCARF THREAD-HEAD™ SCREW is indicated for fixing the elective osteotomies of the mid-foot bones and the metatarsal and phalanges of the foot only.
The SCARF THREAD-HEAD™ SCREW is a cannulated thread-head screw made of a Titanium alloy. Screws come in lengths of 10-32 mm in 2 mm increments.
This document describes a medical device, the SCARF THREAD-HEAD™ SCREW, and its intended use. It does not contain the information requested about acceptance criteria, device performance, studies involving AI, or ground truth establishment for a training set. The provided text is a summary of safety and effectiveness for a bone fixation screw and focuses on its description, intended use, and comparison to predicate devices, along with a single mechanical test.
Therefore, I cannot populate the table or answer the questions based on the provided text. The document is about a physical medical device, not an AI or software-based device that would typically have the kind of performance metrics and study details you've requested.
§ 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.