(119 days)
Synthes 1.5mm Headless Compression Screws are indicated for fixation of intra-articular and extra-articular fractures, avulsions, non-unions, and osteotomies of small bones and small bone fragments; as well as arthrodeses of small joints.
The Synthes 1.5mm Headless Compression Screws are solid bone fixation screws featuring a partially threaded shaft and threaded head. The screws are available in stainless steel and titanium.
The provided text is a 510(k) summary for a medical device called "Synthes (USA) 1.5mm Headless Compression Screws." This document focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing a study for acceptance criteria of an AI/ML powered device.
Therefore, the information required to answer your questions regarding acceptance criteria, study details, sample sizes, ground truth, and expert involvement for an AI/ML device is not present in the provided text. The document is typical for a traditional medical device submission, which relies on engineering and material testing, and comparison to predicate devices, rather than clinical performance studies with AI components.
§ 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.