(387 days)
The BRM TOOL Screws are indicated for use for aligned bone fracture repair and arthrodesis, osteotomy, joint fusion and bone fragment fixation appropriate with the size of the screw.
The BRM TOOL Screws are interfragmentary compression osteosynthesis screws, i.e., devices used in surgical orthopedic interventions to provide support to the bone, ligament, tendon or cartilage structure, with the aim to reduce fractures in several parts of the skeleton, particularly of bone epiphyses. The application field excludes spinal, rib cage and skull bones. The BRM TOOL Screws are available in Titanium alloy.
The provided document is a 510(k) summary for the BRM TOOL Screws, a medical device for bone fixation. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain information about an AI/ML device or a study involving human readers or AI assistance.
Therefore, I cannot provide the requested information regarding acceptance criteria and performance of an AI/ML device because the document does not describe such a device or study.
The document discusses mechanical testing of the screws (torsional yield strength, driving torque, and pullout strength) and mentions that results met predefined acceptance criteria per ASTM F543 and ASTM F1264, and LAL testing, but this relates to the physical characteristics of the screws, not an AI/ML system.
§ 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.