(21 days)
The Modular PLUS Revision Stem is intended for cementless use in fractures of the femur where a long section of the bone is damaged and the stem must anchor into the distal half of the femur.
The Modular PLUS Revision Stem is a cementless two part modular stem that consists of distal anchorage module and proximal revision module, connected by a multi-stage tapered coupling, secured by a cylindrical screw. The proximal module has a standard 12/14 taper to accept modular heads. The Modular PLUS stem is manufactured from Ti-6Al-4V alloy that conforms to ASTM F136. The surface is grit blasted with corundum to produce a surface roughness of 4-6um. This submission adds three additional proximal modules, designated as size AX, BX and CX, have the same circumferential dimensions as the previously cleared AS/AL, BS/BL and CS/CL proximal modules. The differences lie in the overall length of the components. The AX module increases by 15.4mm, the BX module by 18.7mm and the CX module by 22.7mm.
This document is a 510(k) summary for the Modular PLUS Revision Stem, a medical device. It describes the device, its intended use, and claims substantial equivalence to a previously cleared device (K030971).
No acceptance criteria or study details proving a device meets acceptance criteria are provided in the given text.
The document discusses "Summary Nonclinical Tests" and states: "Engineering analysis shows that the bending stresses in the taper connection are less for the modified, longer modules." This is the only mention of any testing, but it does not specify acceptance criteria, test methodology, sample sizes, ground truth, or expert involvement, as this is a mechanical engineering analysis of a physical implant, not a study of an AI/ML device.
Therefore, I cannot provide the requested table or information regarding acceptance criteria and studies for an AI/ML device based on the provided text. The document is for a traditional medical device (hip stem) and does not involve AI/ML.
§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.