(175 days)
The Apex Hip System Bipolar Head is intended for use in combination with an Apex Hip System femoral stem for uncemented primary or revision hemiarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate:
- Femoral neck and trochanteric fractures of the proximal femur:
- Osteonecrosis of the femoral head;
- Revision procedures where other devices or treatments for these indications have failed.
The Apex Hip System Bipolar Head consists of a factory assembled UHMVPE liner in a cobalt chrome outer shell, and UHMWPE retention ring. These bipolar heads include outer diameters ranging from 38 to 60 mm, in 1 mm increments, to properly fit the patient anatomy. The smaller bipolar heads (38 to 42 mm) have an inner diameter that mates with a 22 mm diameter femoral head; the larger bipolar heads (43 mm to 60 mm) have an inner diameter that mates with a 28 mm diameter femoral head. The Apex Hip System Bipolar Head may be used for hemiarthroplasty in conjunction with the following Apex Hip System femoral stems: Apex K1, Apex K2, and Apex Modular.
The provided text is a 510(k) Summary for the Apex Hip System Bipolar Head. It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, expert involvement, or ground truth establishment that would typically be found in a study proving device performance for AI/ML devices.
The document is a regulatory submission for a physical medical device (hip prosthesis), which relies on comparison to existing legally marketed devices, rather than a performance study as would be conducted for a new AI/ML diagnostic or therapeutic device.
Therefore, I cannot fulfill your request for the specific details outlined (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC, standalone performance, ground truth types, and training set details) because this information is not present in the provided context for this type of medical device submission.
§ 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.