(34 days)
The iNSitu Total Hip System is indicated for use in skeletally mature individuals undergoing surgery for total hip replacement due to:
· A severely painful and or disabled joint from osteoarthritis, traumator arthritis, avascular necrosis, or congenital hip dysplasia;
· Acute traumatic fracture of the femoral head or neck;
· Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty or total hip replacement
The iNSitu Total Hip System femoral stem is intended for cementless fixation. The iNSitu Total Hip System acetabular cup is intended for cementless fixation. The porous structured surfaces provide biological fixation in a cementless application.
The iNSitu Total Hip Replacement System is an artificial total hip replacement system includes femoral stems manufactured from forged Ti 6Al-4V ELI material, femoral heads manufactured from CoCr alloy and BIOLOX® delta ceramic, acetabular cups (additively manufactured from Ti), acetabular liners manufactured from Vitamin E polyethylene, acetabular bone screws, screw hole covers for the screw holes in the acetabular cups, and apical hole covers for the apical hole in the acetabular cups manufactured from Ti 6Al-4V ELI material.
The provided text is a 510(k) summary for the iNSitu Total Hip System, a medical device for total hip replacement. It demonstrates substantial equivalence to a predicate device and includes information about performance testing.
However, the provided document does not contain information about a study proving that an AI/device meets acceptance criteria, or any of the detailed information requested in the prompt regarding AI model performance, ground truth establishment, sample sizes for training/test sets, expert adjudication, or MRMC studies.
Therefore, I cannot extract the requested information from the provided text. The document describes a physical medical device (hip replacement system) and its performance testing as per FDA regulations for 510(k) clearances, which typically involves mechanical and material properties, not AI algorithm performance.
§ 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.