(83 days)
Total hip replacement or hip arthroplasty is indicated in the following conditions:
- A severely painful and/or disabled joint from osteoarthritis, rheumatoid arthritis, or congenital hip dysplasia.
- Avascular necrosis of the femoral head.
- Acute traumatic fracture of the femoral head or neck.
- Certain cases of ankylosis.
Hemi-hip arthroplasty is indicated in the following conditions:
- Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated fixation.
- Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation.
- Avascular necrosis of the femoral head.
- Non-union of femoral neck fractures.
- Certain high subcapital and femoral neck fractures in the elderly.
- Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement.
- Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hemi-hip arthroplasty.
The ACTIS™ DUOFIX™ Hip Prosthesis - Collarless is indicated for cementless use only.
The DePuy Actis DuoFix Hip Prosthesis – Collarless is a forged titanium (Ti-6Al-4V) femoral stem designed to be used as one component of a system of prostheses in hip arthroplasty. The stems are compatible with both unipolar and bipolar femoral heads intended for hemi-hip arthroplasty and with modular metal and ceramic femoral heads intended for total hip arthroplasty.
The Actis DuoFix Hip Prosthesis – Collarless implants have sintered commercially pure titanium bead porous coating (Porocoat®) and a thin layer of plasma-sprayed hydroxyapatite (HA) coating. The stem consists of a wide range of stem neck designs and sizes allowing an accurate anatomical match for each patient.
The Actis DuoFix Hip Prosthesis – Collarless is designed as a line extension to the primary predicate Actis DuoFix Hip Prosthesis (K160907) to meet the need of surgeons whose preference is to use a femoral stem without a collar for hip arthroplasty.
I am sorry, but the provided text does not contain information about the acceptance criteria or a study that proves a device meets those criteria, especially in the context of an AI/ML-based medical device.
The document is a 510(k) premarket notification for a hip prosthesis (Actis DuoFix Hip Prosthesis - Collarless). It focuses on demonstrating substantial equivalence to predicate hip prostheses based on material, design, intended use, indications for use, and non-clinical testing (fatigue testing, biocompatibility, MRI safety, bacterial endotoxin testing, HA characterization).
Therefore, I cannot extract the specific information requested about acceptance criteria, device performance, sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, ground truth types, or how ground truth was established for a machine learning model, as this information is not present in the provided text.
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.