(66 days)
The ICONACY I-Hip is indicated for the following conditions: (1) a severely painful and/or disabled hip joint as a result of osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia, (2) avascular necrosis of the femoral head, (3) acute traumatic fracture of the femoral head or neck, (4) failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement, (5) certain cases of ankylosis, (6) nonunions, correction of functional deformity, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
The ICONACY I-Hip consists of femoral stem and acetabular cup (i.e. shell) porous coated components intended for cementless, press-fit fixation.
The ICONACY I-Hip consists of a collarless, tapered, forged titanium allov femoral stem mated to a cobalt chrome alloy modular femoral head. Forty percent of the femoral stem is circumferentially coated with a titanium coating designed to attain a cementless, press-fit fixation. This femoral construct articulates with an acetabular device assembly.
The acetabular device assembly consists of a hemispherical titanium alloy cup coupled with a highly cross linked ultra-high molecular weight polyethylene (HXL-UHMWPE) liner. The acetabular cup is machined from forged Ti-6Al-4V ELI alloy and is available in standard, finned and spike configurations. The acetabular cup has a threaded polar hole for insertion. The standard and finned cups have screw holes for additional fixation.
The outer hemispheric surface of the acetabular cup has a titanium plasma spray coating for cementless, press-fit fixation. A titanium locking ring is fixed into a groove on the cup to engage a groove on the HXLUHMWPE liner. Standard instrumentation is used to implant the device.
The current submission addresses modifying the standard and finned acetabular cups to add a third screw hole. The acetabular cup materials, porous coating and indication for use remain the same. No additional sizes are being added to the product line. No new instruments are required. The spiked cups are unchanged with no screw holes.
The compatible femoral stems, femoral heads, acetabular liners and bone screws remain unchanged from those cleared under K121034.
The provided text is a 510(k) summary for the ICONACY I-Hip, a hip joint prosthesis. The document focuses on showing substantial equivalence to a predicate device, specifically regarding a minor modification to the acetabular cup. It does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML device.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these are not discussed in this medical device submission.
The document states: "Clinical testing was not required to establish equivalency of the device." and "Finite Element Analysis (FEA) confirmed that adding a third screw hole to the acetabular cups had little impact on cup stiffness." This indicates that the safety and effectiveness were established through non-clinical means (FEA) and comparison to a legally marketed predicate device, rather than a clinical study with performance metrics in the way your request implies for an AI/ML 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.