(161 days)
Kirschner wires are indicated for fixation of bone fractures, bone reconstruction, and as guide pins for insertion implants. The size of Kirschner wire should be adapted to the specific indications
The Precifit Medical Kirschner wire is a stainless steel (316LVM) wire available with two point styles: smooth and threaded. The wires are available in various diameters (1.0 - 2.5mm) and lengths (120 -200mm). One end is fixed on standard surgical power tool equipment for insertion. The Precifit Medical Kirschner wire is supplied non-sterilized by the end user. It is intended for single use only.
This document is a 510(k) premarket notification for the Precifit Medical Kirschner Wires and does not contain information about an AI/ML powered device. Therefore, I cannot extract the requested information regarding acceptance criteria, study details, and AI/ML specific metrics.
The document pertains to a medical device (Kirschner Wires) that are physical implants used for bone fixation, not a digital health product or algorithm. The sections referring to "Non-clinical testing" and "Clinical testing" confirm that the device conforms to an international standard (ISO 5838-1 (2013)) and that clinical testing was not required to demonstrate substantial equivalence. This indicates a traditional medical device submission, not one involving AI/ML performance evaluation.
§ 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.