(129 days)
Avenir Complete Hip System is intended for total or hemi hip arthroplasty and is indicated for the following conditions:
· Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases.
- Failed previous hip surgery including joint reconstruction (osteotomy), arthrodesis, hemi-arthroplasty or total hip replacement (THR).
- · Acute traumatic fracture of the femoral head or neck.
- · Avascular necrosis of the femoral head.
Avenir Complete Hip System is for cementless use only.
Avenir Complete Hip System consists of femoral hip stems intended for use in total or hemi hip arthroplasty. The stem is designed for cementless implantation into the proximal femur and mates with compatible femoral heads and adapters for use in total or hemi hip arthroplasty through a 12/14 male taper connection. The stems are manufactured from a forged titanium alloy Ti-6Al-4V and have a wedge-shaped design, with a proximal-to-distal taper and a reduced distal geometry. Apart from the highly polished femoral neck region, the entire surface of the stem is grit-blasted and plasma sprayed with commercially pure titanium (CP-Ti) followed by hydroxyapatite (HA) coating. Offered in multiple sizes and neck lengths, the stems are available in Standard, High Offset, and Coxa Vara offsets and as collared or collarless stems in each offset to accommodate various patient anatomies. The hip stems are provided sterile and are for single-use only. System-specific instrumentation is available to prepare the femur for implantation of the Avenir Complete Hip System femoral stems.
The provided text is a 510(k) Premarket Notification summary for a medical device, the Avenir Complete Hip System. It details the device's purpose, indications for use, technological characteristics, and importantly, mentions the absence of clinical data collection.
Therefore, the document does not contain any information regarding acceptance criteria, device performance from a clinical study (i.e., human-in-the-loop or standalone AI performance), sample sizes for test or training sets, expert consensus for ground truth, adjudication methods, or MRMC studies.
The "Summary of Performance Data (Nonclinical and/or Clinical)" section explicitly states: "Clinical data and conclusions were not needed for this device." and then lists non-clinical (engineering) testing.
Therefore, I cannot provide the requested information based on the given text. The device's approval was based on demonstrating substantial equivalence to predicate devices through non-clinical performance data and analyses, not through clinical performance evaluation as would be done for an AI/ML powered device.
§ 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.