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Biomet's Fenning Femoral Component is composed of a metallic femoral stem which is designed to articulate with a commercially available acetabular component. The device limits translation and rotation via the geometry of the articulating surface. There is no linkage across the joint. The stem has a 30° collar with plasma spraved porous coating circumferentially on the underside of the collar, including the cone; the porous coating extends to the proximal lateral 1/4 of the stem: 1.5 inches from the top laterally to below the collar medially. Porous coating is to achieve biological fixation to the surrounding bone by tissue, either bone or soft tissue, without the use of bone cement. The porous coating on the underside of a collar and the extended proximal lateral porous coating provide areas of potential tissue ingrowth in crucial regions of cortical bone. The conical collar design provides a larger contact surface for stress transfer to the proximal femur via the collar wedging into the bone. The wedging of the implant into the canal allows the entire collar to sit on cortical bone occluding the proximal canal while providing rotational stability of the stem. There is no lateral collar eliminating the need to resect the greater trochanter. The stem is tapered, following the natural contours of the canal. The stem below the porous coating to the middle portion is "grit blasted" for a roughened surface of 200 microinches. The distal half of the stem is smooth and fluted. The flutes provide additional rotational stability. There is a distal coronal slot to minimizes distal stem stiffness. The device will be available in 5 stem sizes of diameters 9mm to 17mm at 2mm increments with corresponding stem lengths of 145mm to 165mm at 5mm increments. The stem is straight eliminating the need for left and right configurations.
This document is a Summary of Safety and Effectiveness for a medical device, specifically Biomet's Fenning Femoral Component, a hip replacement prosthesis. It does not describe a study that uses an AI/ML device or algorithm.
Therefore, I cannot extract the information required in your request, such as a table of acceptance criteria for an AI device, sample sizes for test/training sets, expert information, or details about an MRMC study. This document pertains to the regulatory submission for a physical medical device, not a software-based one.
If you have a document describing an AI/ML medical device study, I would be happy to analyze it according to your criteria.
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.