Search Results

Not Found

The Collarless Polished Taper and Collarless Polished Taper LS Hip Prostheses for total hip arthroplasty consists of femoral stems which are manufactured from forged cobalt-chrome. They are available in a modular configuration. The femoral stems are straight and collarless. The femoral stems may be used with Zimmer femoral heads and corresponding acetabular liners and shells.

The provided document is a Summary of Safety and Effectiveness for Zimmer hip prostheses, dated February 14, 1996. This type of document is typically submitted to regulatory bodies (like the FDA in the US) for device clearance. It focuses on demonstrating that a new device is substantially equivalent to legally marketed predicate devices in terms of safety and effectiveness.

This document describes a medical device (hip prosthesis) and not an AI-powered software device. Therefore, the questions regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies, which are highly relevant for AI/ML-based medical devices, are not directly applicable to this document.

The document's purpose is to summarize the physical characteristics, materials, and intended use of the hip prostheses, and to compare them to existing devices. It does not contain sections on:

• Acceptance Criteria for an AI Model: These would typically involve metrics like sensitivity, specificity, AUC, F1-score, or accuracy targets.
• Study Data (Test Set/Training Set): There are no mentions of imaging data, patient cohorts for diagnostic performance, or data provenances.
• Expert Ground Truth: The concept of establishing "ground truth" through expert consensus is pertinent to diagnostic interpretation, not the physical properties or performance of a mechanical implant in the way an AI model would be evaluated.
• MRMC Studies or Standalone Performance: These are methodologies for evaluating the diagnostic performance of AI or human readers, which is not the subject of this document.

In summary, the provided document does not contain the information requested because it pertains to a mechanical medical device (hip prosthesis) clearance, specifically under the "Substantial Equivalence" pathway, and not an AI/ML-based diagnostic or prognostic software device.

Therefore, I cannot populate the requested table and sections with information from this document.

Ask a specific question about this device