(42 days)
The Alta® Fully Threaded Cross-Locking Screws are intended to be used in conjunction with the Alta® Femoral and Alta® Tibial/ Humeral Intramedullary Rod Systems. Specifically, the screws are used to lock the IM rods in position after placement in the femoral canal.
The fully threaded screws are manufactured from a Titanium alloy and are available in 5.0mm and 3.7mm diameters in lengths of 25 to 100mm.
The provided text describes a 510(k) summary for a medical device, the Alta® Fully Threaded Cross-Locking Screws. This document focuses on demonstrating substantial equivalence to predicate devices, which is a regulatory pathway for lower-risk medical devices. It does not contain information about acceptance criteria, device performance studies, or AI-related evaluations.
Therefore, I cannot provide the requested information as it is not present in the input text.
The input document is a 510(k) summary, which is a regulatory submission for medical devices to demonstrate substantial equivalence to a legally marketed predicate device. Such summaries typically do not include detailed performance studies with acceptance criteria, ground truth establishment, or AI-related metrics like those 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.