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

· Patient conditions of non-inflammatory degenerative joint disease (NIDJD): 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 with Cobalt 3D™, and the Klassic Tibial Baseplate with Ti-Coat®, which are indicated for cementless use.

The purpose of this 510(k) is to add Klassic® Knee CR/Congruent Tibial Inserts and Ultra-PS® Tibial Inserts, which are fabricated with E^X Poly, to the Klassic® Knee System. E^X Poly is a crosslinked UHMWPE containing alpha-tocopherol. The subject Klassic® Knee CR/Congruent and Ultra-PS® Tibial Inserts are available in various sizes and thicknesses to match patient anatomy.

The provided text is a 510(k) summary for the Klassic Knee System, focusing on the addition of new tibial inserts. It outlines the device description, indications for use, and a comparison to predicate devices, but it does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of AI/ML or diagnostic performance.

The document primarily describes the regulatory submission for a physical medical device (knee implants) and its substantial equivalence to previously cleared devices based on bench testing and engineering analyses for wear, stability, stress, range of motion, and modular disassembly. It does not mention any AI/ML components, digital image analysis, or diagnostic performance evaluation studies that would typically involve acceptance criteria for metrics like sensitivity, specificity, or AUC, or require a test set with ground truth established by experts.

Therefore, I cannot extract the requested information (1-9) from the provided text. The document is about a mechanical orthopedic implant, not a diagnostic AI/ML device.

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

• Patient conditions of non-inflammatory degenerative joint disease (NIDJ): . 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 purpose of this 510(k) is to add Klassic® Knee CR/Congruent Tibial Inserts with E-Link®, Ultra-PS® Tibial Inserts with E-Link®, Sombrero Patellae with E-Link® and Domed Patellae with E-Link® ("E-Link® Knee Components") to the Klassic® Knee System. These components are manufactured from E-link®, a Vitamin E blended UHMWPE crosslinked by gamma irradiation. The E-Link® Knee Components are available in various sizes and thicknesses to match patient anatomy.

The provided text is a 510(k) summary for the Klassic® Knee System. It does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML-enabled device. The document is for a traditional medical device (knee replacement system) and focuses on substantial equivalence based on engineering analyses and bench testing, rather than performance metrics related to diagnostic or predictive accuracy.

Therefore, I cannot provide the requested information. The document does not describe any AI/ML model.

Ask a specific question about this device