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The product is intended for total or hemi hip arthroplasty with cemented applications for rehabilitating hips damaged as a result of:

• Advanced wear of the joint due to degenerative, post-traumatic, or rheumatic diseases
• Failed previous hip surgery including joint reconstruction (osteotomy), arthrodesis, hemiarthroplasty or total hip replacement (THR)
• Acute traumatic fracture of the femoral head or neck
• Avascular necrosis of the femoral head.

The Avenir Cemented Hip Stem is a femoral hip prosthesis that is designed for cemented fixation into the intramedullary canal for pathological or degenerative conditions involving the femur that merit total or hemi hip arthroplasty. The Avenir Cemented Hip Stem is a straight, doubletapered stem manufactured from Protasul - S30 stainless steel material. The tapered aspects of the stem match the Avenir-Müller Stem, and promotes self-locking of the stem within the femoral canal.

The provided document K131884 is a 510(k) summary for a medical device called the "Avenir® Cemented Hip Stem." This document describes the device, its intended use, and its comparison to predicate devices, along with non-clinical performance data.

Crucially, this document explicitly states under the section "Clinical Performance and Conclusions:"

"Clinical data and conclusions were not needed for this device."

This means that a clinical study, including human performance testing or reader studies, was not performed to demonstrate the device's substantial equivalence or safety and effectiveness. The basis for clearance was non-clinical (lab) performance testing and comparison to predicate devices.

Therefore, the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, ground truth, and training sets cannot be extracted from this document as such a study was not conducted or reported.

The document focuses on non-clinical testing such as:

• Accelerated Corrosion Fatigue Test
• Proximal & Mid-Stem Fatigue Testing
• Pull-off Strength testing and rationale
• Summary of Burst Strength Testing
• Range of Motion analysis.

These tests are designed to demonstrate the physical and mechanical performance of the implant itself, not the performance of an AI algorithm or human readers interpreting images.

Since the prompt asks for details about a study that proves the device meets acceptance criteria related to AI or clinical performance, and the document explicitly states clinical data was not needed, I cannot provide the requested information based on the provided text.

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