(88 days)
The Acetabular Shells with Mesh Ingrowth Surface are intended to be used for uncemented, primary reconstruction of the acetabular portion of the hip joint during total hip arthroplasty.
The Acetabular Shells with Mesh Ingrowth surface are a series of Vitallium® acetabular components intended for the primary reconstruction of the acetabulum during total hip arthroplasty. These components are designed with a mesh ingrowth surface that is integrally cast in to the shell substrate. The shells are available in a range of outer diameters to accommodate various anatomical requirements. These shells are available in four styles; a solid back, a solid back with visualization hole, a cluster shell with screw holes, and a shell that is pre-assembled with the plastic insert.
I am sorry, but the provided text does not contain the information required to answer your request. The document describes a medical device, Acetabular Shells with Mesh Ingrowth Surface, and its regulatory clearance (510(k) summary). It discusses substantial equivalence to existing devices and mentions mechanical and biological testing to demonstrate equivalence to a sintered beaded porous coating.
However, it does not include:
- A table of acceptance criteria and reported device performance.
- Details on sample sizes, data provenance, or study design for specific tests.
- Information about experts, ground truth establishment, or adjudication methods.
- Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study, effect sizes, or human readers.
- Details about standalone algorithm performance.
- Sample size or ground truth establishment for a training set (as this pertains to AI/ML devices, which this is not).
The document is a regulatory submission for a physical medical implant, not an AI/ML diagnostic or predictive device, which is typically where the requested information about acceptance criteria, ground truth, experts, and reader studies would be found.
§ 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.