(17 days)
The ESOP® Co-Cr Femoral Heads are intended for use in degenerative and inflammatory arthritis of the hip joint, trauma, non-acute femoral neck fracture, revision of previously failed hip arthroplasties, and idiopathic avascular (osteo) necrosis where radiographic evidence shows there is sufficient sound bone to seat the prosthesis. This device is intended for cementless application.
The Metallic Femoral Heads are intended to be adapted to special cones machined for this purpose. Femoral head are available in several diameters for use in full hip or intermediary replacement. The length of the neck on the femoral stem can be adjusted by using the heads available in different insertion depths (short, medium, long and extra-long collars), and of different diameters.
The provided text describes a 510(k) submission for the ESOP® Co-Cr Femoral Head, a medical device. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than conducting a de novo study to establish new acceptance criteria and prove performance against them.
Therefore, the input does not contain the kind of information requested in the prompt, such as pre-defined acceptance criteria, details of a study (sample sizes, ground truth, experts, adjudication, MRMC, standalone performance, training set details), or the reported device performance against such criteria.
The submission focuses on comparing the new device (ESOP® Co-Cr Femoral Head) to existing legally marketed predicate devices (ESOP® Co-Cr Femoral Heads (K021109) and Total Hip Femoral Head - 12/14 Taper (K021673)) in terms of intended use, material, size, and dimensions, to demonstrate that the new device is substantially equivalent. It states that "Verification/validation and design control activities demonstrate the safety and effectiveness," but does not detail the specifics of these activities in the way requested for acceptance criteria and study results.
Therefore, I cannot provide the requested information from the given text. The document describes a regulatory submission for a medical device built on the principle of substantial equivalence, not a study designed to establish and meet specific performance acceptance criteria for a novel device.
§ 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.