(174 days)
The VerSys Epoch Fullcoat Hip Prosthesis is indicated for:
- Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur.
- Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis.
- Patients suffering from disability due to previous fusion.
- Patients with acute femoral neck fractures.
The VerSys Epoch Fullcoat Hip Prosthesis is a modular, metal-polymer composite femoral stem designed to replace the proximal human femur in total hip arthroplasty. It features a 12/14 Morse-type taper to accommodate the attachment of modular femoral heads. The proximal body geometry of the proposed device is trapezoidal and two body options (standard and large metaphysis) are offered in sizes 13mm through 22mm to meet patient anatomical requirements. The VerSys Epoch Fullcoat Hip Prosthesis is available in both standard and extended neck offsets to allow for restoration of optimal joint kinematics and maximum stability without altering leg length.
The provided text is related to a 510(k) premarket notification for a medical device: the VerSys® Epoch® Fullcoat Hip Prosthesis. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing performance data from a study that uses acceptance criteria. Hip prostheses are typically cleared based on mechanical performance testing and material equivalence to previously cleared devices, not clinical studies with acceptance criteria for algorithm performance.
Therefore, the specific information requested in your prompt (e.g., acceptance criteria table, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance) is not applicable and cannot be extracted from the provided text. The document explicitly states:
"Non-Clinical Performance and Conclusions: Non-clinical testing demonstrated that this device met performance requirements and is as safe and effective as the predicate device."
"Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device."
This means the device was cleared based on non-clinical (e.g., mechanical) testing, and no human-in-the-loop or standalone algorithm performance studies were conducted or required for this type of device and regulatory pathway.
§ 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.