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The Klassic® Knee System is intended for prosthetic replacement of the following:

• · Patient conditions of non-inflammatory degenerative joint disease (NID): avascular necrosis and osteoarthritis
• · Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis
• · Patients with failed previous surgery where pain, deformity, or dysfunction persists
• · Correctable varus-valgus deformity and moderate flexion contracture
• · Revision of a previously failed knee arthroplasty
• · Patients who require a total knee replacement

The Klassic® Knee System is indicated for cemented use only, except for the Klassic Femur, Porous, and the Klassic Tibial Baseplate, Porous, which are indicated for cementless use.

The Klassic® Femur with Aurum®, is being introduced as a line extension for use with the Klassic® Knee System for cemented implantation during total knee arthroplasty. The Klassic® Femur with Aurum® is manufactured from Titanium alloy (Ti6Al4V per ASTM F136) with a titanium nitride surface.

The provided text is a 510(k) Premarket Notification for a Knee Joint Prosthesis (Klassic® Knee System). It details the device's indications for use, its classification, and a comparison to predicate devices, particularly focusing on a new line extension, the Klassic® Femur with Aurum®.

This document does not contain any information regarding AI/ML device performance testing, clinical studies with human readers, or ground truth establishment relevant to AI/ML systems. The "acceptance criteria" discussed are likely related to the mechanical and biocompatibility performance of the knee implant, not an AI/ML algorithm's diagnostic accuracy.

Therefore, I cannot provide an answer based on the prompt's request for AI/ML device performance without the presence of such information in the provided text.

The closest relevant sections in the provided text are:

• Non-Clinical Bench Testing and Engineering analyses: These were performed to evaluate the physical properties of the Klassic® Femur with Aurum® (e.g., strength of coating, fatigue, wear, stability, contact stress, range of motion, patella-femoral resistance). This refers to the mechanical integrity and function of the physical implant, not an AI algorithm.
• LAL testing requirements for orthopedic implants: This refers to Limulus Amebocyte Lysate testing for bacterial endotoxins, a biocompatibility test, not an AI algorithm's performance.

To answer your request, the input text would need to describe a study evaluating an AI/ML algorithm's performance, including details such as:

• Acceptance criteria for algorithm metrics (e.g., sensitivity, specificity, AUC).
• Test set characteristics (sample size, data provenance, image types).
• Ground truth establishment (number and qualifications of experts, adjudication methods).
• Human reader studies (MRMC design, effect sizes of AI assistance).
• Standalone algorithm performance.
• Training set details (sample size, ground truth methodology).

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