(28 days)
The PLUS Cancellous Bone Screws are intended as a bone fixation device for a variety of surgical applications, such as fixation of press-fit acetabular cups in total hip arthroplasty or acetabular revisions, tibial components in total knee arthroplasty of knee revisions, and fixation of small and long bone fractures.
WARNING: These cancellous bone screws are not intended for spinal fixation.
The PLUS cancellous bone screws are presently available, non-sterile, as part of complete instrument and implant sets for the following predicate devices manufactured by PLUS: BOFOR® Revision Cup - K993874 – S/E/ 6/5/00 EPF®-PLUS Acetabular Cup - K994146 – S/E 12/11/00 These identical cancellous bone screws are now available, sterile, packaged individually in triple peel pouches (sterilized by Gamma irradiation). They are manufactured from Ti-6Al-4V ELI according to ASTM F136-98. They have a thread diameter of 6.5 mm and come in 10 lengths in 5 mm increments ranging from 15 mm to 60 mm. They have a standard 3.5 mm hexagonal screw head.
The provided text is a 510(k) Summary and related FDA correspondence for a medical device called "PLUS Cancellous Bone Screws." This document outlines the device's description, indications for use, and a comparison to predicate devices, focusing on regulatory equivalence for a modification (sterile presentation) of an already available device.
It does not contain information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or training set details for an AI/algorithm-based device.
The document is purely for regulatory approval of a modified physical medical device (bone screws) and demonstrates substantial equivalence to existing devices through comparison of design, materials, and intended use. Performance is implicitly covered by the established safety and effectiveness of the predicate devices.
Therefore, I cannot fulfill your request to describe the acceptance criteria and study proving device performance as the provided text does not contain this information for an AI/algorithm-based device.
§ 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.