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The Duracon® Total Knee System components are for use in total knee arthroplasty to relieve pain and restore knee function for indications such as: noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis or avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments or devices have failed; post traumatic loss of joint anatomy, particularly when there is patello-femoral erosion, dysfunction or prior patellectomy; and, irreparable fracture of the knee. These products are intended to achieve fixation without the use of bone cement.

The device includes femoral, tibial and patellar components of a total knee system. These components are used for the replacement of the bearing and/or articulating surfaces of the distal femur, proximal tibia and patella to relieve pain, instability and the restriction of motion due to degenerative bone disease, including osteoarthritis, rheumatoid arthritis, failure of other devices or trauma.

I am sorry, but based on the provided text, there is no information about a study that used a test set, expert readers, or ground truth to evaluate device performance. The document describes a 510(k) premarket notification for a medical device (Duracon® Total Knee System with Peri-Apatite Coating) and primarily focuses on demonstrating substantial equivalence to a predicate device through engineering testing and material characterization.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance related to a clinical or AI-based study.
• Sample size used for a test set or its provenance.
• Number and qualifications of experts for ground truth establishment.
• Adjudication method for a test set.
• MRMC comparative effectiveness study results.
• Standalone algorithm performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• Sample size for the training set.
• How ground truth for the training set was established.

The provided text only mentions:

• Summary of Data: "A risk analysis and research and development testing have been performed to demonstrate equivalence of the proposed products to the predicate devices. The testing includes porous coating characterization, baseplate fatigue testing, contact area / stress analyses; range of motion range of constraint testing; locking mechanism testing; UHMWPe material properties in accordance with the Class II Special Controls Guidance Document... The testing also includes safety testing for the Peri-Apatite coating."
• Conclusion of Data: "The results demonstrate that the Duracon Total Knee System with Peri-Apatite coating is safe and effective for total knee replacement without bone cement."

These are engineering and material-specific tests, not studies involving human readers or AI algorithms to interpret data or make diagnoses.

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