(87 days)
The LINK ® MP® Monoblock is indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur which cannot be treated by conservative or osteosynthetic procedures
The LINK® MP® Monoblock is indicated for the following conditions:
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Revision of loosened femoral prosthesis components involving extensive bone resorption of the proximal femur and widening of the medullary cavity or marked thinning of proximal femoral cortical bone the fixation of a new standard prosthesis is not possible
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Revision of loosened femoral prosthesis components by peri-/subprosthetic fracture
The device is intended for cementless use.
The LINK® MP® Monoblock Hip Prosthesis is a straight hip prosthesis stem. The hip prosthesis is made of Titanium Aluminum Vanadium alloy (Ti-6Al-4V). The prosthesis stems are available in a range of sizes, lengths, CCD angles and offsets. Additional features include a tapered stem with a microporous glass-blasted surface.
The LINK® MP® Monoblock Hip Prosthesis is designed to be used in conjunction with femoral heads that are manufactured from Cobalt Chromium Molybdenum casting alloy (CoCrMo) or ceramic (BIOLOX® forte and BIOLOX® delta) via 12/14 morse taper (K161840). In total joint use, the femoral head articulates aqainst LINK® BiMobile Cup System (K171273). The LINK® MP® Monoblock Hip Prosthesis provides cementless fixation to the bone.
The provided text is related to an FDA 510(k) premarket notification for a medical device, the "LINK® MP® Monoblock Hip Prosthesis." This document concerns the regulatory clearance of a physical medical device (an orthopedic implant), not an AI/ML software.
Therefore, the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies related to AI/ML performance is not applicable to this document.
The document states:
- "Non-clinical performance testing and analysis were provided, including bench testing." This refers to physical tests on the implant, not a study involving data or AI.
- "There was no clinical performance testing required for this device." This explicitly states that human clinical trials were not part of this submission for demonstrating substantial equivalence.
In summary, the provided content does not contain the information requested about AI/ML device performance or the study details typically associated with it.
§ 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.