(89 days)
Arthrodesis cannulated screws are designed for the following indication: Arthrodesis of the metatarsal-phalangeal joint of the big toe.
BePOD® Cannulated Arthrodesis Screws includes the following elements: BePOD® Arthrodesis cannulated screws. The BePOD® Cannulated Arthrodesis Screws is intended to be implanted using the dedicated instrumentation supplied by the manufacturer.
This is a 510(k) premarket notification for a medical device, specifically the BePOD® Cannulated Arthrodesis Screws. Such notifications typically focus on demonstrating substantial equivalence to a predicate device rather than providing detailed studies on a device's performance against specific acceptance criteria for AI algorithms.
Therefore, the requested information regarding acceptance criteria, study details for AI performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, and standalone performance is not applicable to this document.
This document describes a traditional medical device (screws for bone fixation), not an AI/ML-driven device. The "Performance" section refers to material testing (LAL testing) and compliance with manufacturing regulations, not performance metrics based on data analysis or AI algorithms.
§ 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.