(96 days)
The Klassic HD® Hip System is intended for prosthetic replacement in treatment of the following: · Patient conditions of non-inflammatory degenerative joint disease (NIDJD): avascular necrosis, osteoarthritis, ankylosis, protrusio acetabuli and painful hip dysplasia.
· Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis.
- · Those patients with failed previous surgery where pain, deformity, or dysfunction persists.
· Revision of a previously failed hip arthroplasty.
· Patients who require a total hip replacement.
The Klassic HD® Hip System employs prostheses designed to help surgeons restore hip joint biomechanics intra-operatively. The purpose of this Special 510(k) is to add BIOLOX CONTOURA® Ceramic Femoral Heads in diameters of 28mm, and 36mm, in various head offsets.
The provided text describes a 510(k) premarket notification for a medical device, the BIOLOX CONTOURA Ceramic Femoral Head. It focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and function, supported by various mechanical tests and engineering analyses.
However, the document does not contain information about acceptance criteria and study details related to the performance of an AI/algorithm-driven device. The text describes a traditional medical device (a ceramic femoral head for hip replacement), and the performance evaluation is based on mechanical testing (burst strength, fatigue, pull-off, torque disassembly) and engineering analyses for physical characteristics like impingement, range of motion, and wear, rather than clinical performance or AI algorithm performance.
Therefore, I cannot fulfill the request as it pertains to AI/algorithm acceptance criteria and studies. The provided document is about a manufactured medical implant and its mechanical properties.
§ 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.