(306 days)
Single use, camented or pressfit hip replacement component for use in patients requiring joint replacement due to trauma, disease or failed previous hip replacement surgery.
The Achantage MAPF Femoral Component is a cobalt alloy (Co-Cr-Mo) fernoral stam which is designed to articulate with any commercially available acetabular component. It has no linkage across the joint.
The MAPF devices are straight, as apposed to anatomic or curved in design. This eliminates the need for left and right configurations thus recucing the cost of inventory to the hospital. The Hosam distal goometry increases the strength and flexibility of the device. The lateral edge of the device is straight which anables the surgeon to rasp and asat the prosthesis, without creating a gap in the proximal lateral aspect of the femur. A lateral fin provides rotational stability. The duckbill type collar prevents subsidence.
Available in 6 sizes (diameters) for easier patient matching, all sizes are 160mm in length with a neck length of 32mm. Because this device is usually used in the older, low demand patient, it would most often be used in conjunction with a bipolar or endoprosthetic head.
This document is a Summary of Safety and Effectiveness for a medical device, specifically a hip femoral component. It does not describe an AI/ML-enabled device or a study to prove acceptance criteria for such a device.
The document focuses on the physical characteristics, indications for use, potential risks, and substantial equivalence of a traditional medical implant. Therefore, I cannot extract the requested information (acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) as they pertain to the evaluation of an AI/ML system.
The provided text is a pre-market submission for a conventional medical device, not a study evaluating an algorithmic product.
§ 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.(b)
Classification. Class II.