(148 days)
The Press-fit Porous Acetabular Component is intended for treatment of patients who are candidates for total hip arthroplasty because the natural femoral head and neck and/or acetabulum have been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis or femoral neck fracture, and revision arthroplasty where bone loss is minimal. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.
The metal shell is fabricated from wrought/forged or cast Ti-6A1-4V. The outside surface of the shell is porous coated with commercially pure titanium beads to provide a porous surface for enhanced press-fit fixation.
The metal shell is hemispherical in shape and is available with and without screw holes. The screw holes are for the use of 6.5 mm cancellous bone screws for adjunct fixation. The geometry of the screw holes is such that a 12° angulation of the screws is possible.
The poly liners are manufactured from ultra high molecular weight polyethylene and are available in a neutral and 10° hooded design. The hooded design is intended for those patients prone to subluxation because of soft tissue laxity.
This document describes a medical device, the Foundation® Porous Press-fit Acetabular Component, and its safety and effectiveness. However, it does not describe an AI/ML powered device, nor does it detail a study involving AI/ML performance.
Therefore, I cannot provide the requested information regarding acceptance criteria, study details (sample sizes, ground truth establishment, expert qualifications, etc.), or AI performance metrics.
The "Test Results" section mentions testing on porous coating, tensile and shear strength, and attachment strength of liners to the shell, concluding that "All results are sufficient for in-vivo loading." This indicates traditional engineering/biomechanical testing, not an AI performance study.
To clarify, this document does not contain the information needed to answer the prompt's specific questions about AI/ML device validation.
§ 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.