Search Results

The VerSys Beaded Hip Prosthesis is designed to achieve biologic fixation to bone and is indicated for:

Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusion acetabuli, slipped capital femoral epiphysis, disability due to previous fusion, previously failed endoprostheses and/or total hip components in the affected extremity, and acute femoral neck fractures.

Hemi-hip replacement for the following: fracture dislocation of the hip, elderly, debilitated patients when a total hip replacement is contraindicated, irreducible fractures in which adequate fixation cannot be obtained, certain high subcapital fractures and comminuted fractures, secondary avascular necrosis of the femoral head, pathological fractures of the femoral neck, and osteoarthritis in which the femoral head is primarily affected.

Like its predicate, the VerSys Beaded Fullcoat Bowed Revision Hip Prosthesis is a modular femoral stem manufactured from Co-Cr-Mo alloy and has a sintered Co-Cr-Mo alloy bead porous surface coating. The prosthesis features a 12/14 Morse-type proximal neck taper to mate with the corresponding 12/14 bore of a femoral head component. Proximal body geometry of the prosthesis is trapezoidal.

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving device performance as it relates to software or AI devices.

The document discusses a Zimmer VerSys® Beaded Fullcoat Bowed Revision Hip Prosthesis, which is a physical hip implant. The text is a summary of safety and effectiveness for a 510(k) premarket notification for this medical device, filed in 2003.

It outlines:

• Device Description: A modular femoral stem made from Co-Cr-Mo alloy with a porous surface coating, designed for biologic fixation.
• Intended Use/Indications for Use: Total and hemi-hip replacement for various conditions like arthritis, avascular necrosis, fractures, etc.
• Predicate Device: VerSys Hip System Beaded Hip Prosthesis (K973714).
• Regulatory Classification: Class II, Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

However, the document does not contain any information regarding:

1. A table of acceptance criteria and reported device performance (in terms of specific metrics like accuracy, sensitivity, specificity, or error rates).
2. Sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth types, training set details, or how ground truth for training was established. These are all concepts related to the evaluation of software algorithms or AI systems, not a physical hip implant described in this document.

Therefore, I cannot fulfill your request based on the provided text.

Ask a specific question about this device