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The StelKast Proven Stem Extenders are intended for use with compatible components of the Proven Knee System for the following indications:

1. Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems;
2. Revision of failed previous reconstructions where sufficient bone stock and soft integrity are present; and
3. Cemented use only.

Not Found

The provided document is a 510(k) clearance letter from the FDA for the StelKast Proven Stem Extender, a knee joint prosthesis component. This document grants market clearance based on substantial equivalence to a predicate device.

It does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device, clinical trial, or performance study with metrics like sensitivity, specificity, or AUC.

The document primarily focuses on:

• Confirming 510(k) clearance for the device.
• Indications for Use (for total knee replacement due to various conditions, revision of failed reconstructions, and cemented use only).
• Regulatory classification and associated general controls.
• Points of contact for regulatory guidance.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as these details are not present in the provided text.

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