(22 days)
The STERLING® Interference Screw ST is used to provide interference fixation of f moral and/or tibial tunnels in anterior cruciate ligament reconstruction using a soft tissue graft, and fixation during posterior cruciate ligament reconstruction utilizing a soft tissue graft.
The STERLING® Interference Screw HT is used to provide interference fixation in anterior cruciate ligament reconstruction using a bone-tendon-bone graft, and fixation during posterior cruciate ligament reconstruction utilizing a bone-tendonbone graft.
The STERLING® Interference Screw HT is machined from processed bovine cortical bone, with lengths ranging from 20 to 35mm and diameters ranging from 7 to 12 mm. The STERLING® Interference Screw HT is threaded and has an external squared-drive.
The STERLING® Interference Screw ST is machined from processed bovine cortical bone, with lengths ranging from 20 to 35mm and diameters ranging from 7 to 12 mm. The STERLING® Interference Screw ST is threaded and has an internal hexdrive.
The provided text is a 510(k) summary for the STERLING® Interference Screw HT and ST devices. This document focuses on demonstrating substantial equivalence to predicate devices and does not contain information on acceptance criteria or a study proving device performance against such criteria. The studies mentioned are related to material characteristics and remodeling in an animal model, not clinical performance metrics typically associated with acceptance criteria for AI/ML-based devices.
Therefore, I cannot provide the requested information about acceptance criteria and a study that proves the device meets them, as the provided input does not contain this kind of data. The document describes a traditional medical device (bone fixation screw) and its regulatory submission, not a software or AI/ML device that would typically have acceptance criteria presented in the manner 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.