(252 days)
The device is indicated for use in hip arthroplasty in skeletally mature patients with the following conditions:
- A severely painful and/or disabled joint from osteoarthritis, rheumatoid arthritis, or congenital hip dyplasia.
- Avascular necrosis of the femoral head.
- Acute traumatic fracture of the femoral head or neck.
- Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacment or total hip replacement.
- Certain cases of ankylosis.
Conformity stem is for cementless use only.
The "United" Conformity Stem cementless type is design for cementless use in hip arthroplasty. The Conformity Stem cementless type is a proximal trapezoid and distal quadrangular stem with 12/14 neck taper, 135° and 125° neck angle. It is manufactured from Ti-6A1-4V alloy which conform to ASTM F136-13 and the distal part of each femoral stem is coated with hydroxyapatite (HA) (ASTM F1185-03) to provide biological fixation. The subject device is available in various sizes with collarless and collared types to accommodate various hip surgical requirements.
The provided text describes a 510(k) premarket notification for a medical device called "Conformity Stem," a hip stem for hip arthroplasty. The document asserts the device's substantial equivalence to a legally marketed predicate device.
However, the content does not contain any information related to an AI/ML-driven medical device, nor does it discuss acceptance criteria, device performance metrics (like accuracy, sensitivity, specificity, AUC), sample sizes for test or training sets, ground truth establishment by experts, adjudication methods, or MRMC studies.
The document focuses on the mechanical and material performance of the hip stem, including tests like stem fatigue, neck fatigue, range of motion, and fretting corrosion, all of which are standard engineering and biocompatibility evaluations for an implantable orthopedic device. It explicitly states "Clinical Performance Data/Information: None provided as a basis for substantial equivalence."
Therefore, I cannot fulfill the request as the provided text does not contain the necessary information about an AI/ML device study.
To answer your request, the input text would need to describe an AI/ML device, its intended use for diagnostic or prognostic purposes, and the clinical study conducted to validate its performance according to the specified criteria.
§ 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.