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The Natural-Knee II CoCr Tibial Baseplate is a primary component intended for cemented use only in total knee arthroplasty in skeletally mature individuals for treatment of the following:

• Patient conditions of Noninflammatory Degenerative Joint Disease (NIDJD); . e.g., avascular necrosis, osteoarthritis and Inflammatory Joint Disease (IJD); e.g, rheumatoid arthritis.
• Correctable valgus-varus deformity and moderate flexion contracture. .

The CoCr tibial baseplate, manufactured from cast CoCr alloy (ASTM-F-75), is a nonporous, stemmed configuration and intended for cemented use only. The CoCr tibial baseplate is anatomic and asymmetric in design, available in sizes 00-5 and left and right configurations.

The provided document is a 510(k) summary for the Sulzer Orthopedics Inc. Natural Knee II System CoCr Tibial Baseplate, dated August 9, 2002. This document is a regulatory submission for a medical device and therefore does not contain information about acceptance criteria for device performance as it would be understood for a diagnostic AI/ML device, nor does it describe a study proving the device meets performance criteria in the context of AI/ML.

This document is for a mechanical medical device (a knee implant), not a diagnostic AI/ML device. Therefore, the questions posed, which are designed for assessing AI/ML device performance studies, do not directly apply to the content of this 510(k) submission.

Specifically:

• Acceptance criteria and reported device performance (Table): Not applicable for this type of device and document. Regulatory approval for such a device is based on "substantial equivalence" to a predicate device, which means demonstrating similar technology, materials, and intended use as a device already on the market. There are no performance metrics like sensitivity, specificity, or AUC as expected for an AI/ML diagnostic.
• Sample size and data provenance (test set): Not applicable. There is no "test set" in the context of an AI/ML algorithm evaluation.
• Number of experts and qualifications (ground truth): Not applicable. Ground truth, as defined for AI/ML, is not relevant here. Device safety and efficacy are typically supported by mechanical testing, biocompatibility studies, and comparison to predicate devices, not expert consensus on diagnostic interpretations.
• Adjudication method: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This type of study is for evaluating human performance with and without AI assistance in diagnostic tasks.
• Standalone algorithm performance: Not applicable.
• Type of ground truth: Not applicable.
• Sample size for training set: Not applicable. This device is not an AI algorithm that undergoes training.
• How ground truth for training set was established: Not applicable.

Summary based on the provided document:

The Natural-Knee II CoCr Tibial Baseplate is a mechanical orthopedic implant, specifically a component for total knee arthroplasty. Its approval relies on demonstrating substantial equivalence to an already legally marketed predicate device (the Natural Knee II System Non-porous Stemmed Tibial Baseplate) in terms of general design, intended use, and indications for use. The document specifies that the new device is manufactured from cast CoCr alloy (ASTM-F-75), is nonporous, stemmed, and intended for cemented use only. It is anatomic and asymmetric, available in sizes 00-5 and left/right configurations.

Indications for use include treatment of Noninflammatory Degenerative Joint Disease (e.g., avascular necrosis, osteoarthritis) and Inflammatory Joint Disease (e.g., rheumatoid arthritis), as well as correctable valgus-varus deformity and moderate flexion contracture in skeletally mature individuals.

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