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The indications for the Patient-Specific Vanguard™ Femoral Components are as follows:

• l . Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
• Correction of varus, valgus or posttraumatic deformity. 2.
• 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
     These devices are single-use implants intended for cemented applications.

The Patient-Specific Vanguard™ Femoral Components are comprised of a series of CoCrMo femoral components with each size offering an envelope of acceptable dimensions to allow for a fit that is specific to each patient, while still maintaining the Vanguard" design. These components are intended for primary knee arthroplasty.

This document is a 510(k) premarket notification for a medical device called "Patient-Specific Vanguard™ Femoral Components." It describes the device, its intended use, and claims substantial equivalence to previously marketed devices. However, it does not contain information about acceptance criteria or a study proving that the device meets such criteria.

Specifically:

• No acceptance criteria or device performance table: The document does not provide a table outlining specific acceptance criteria (e.g., performance metrics, thresholds) for the device.
• No study proving acceptance criteria are met: The document explicitly states under "Clinical Testing" that "None provided as a basis for substantial equivalence." Non-clinical testing was performed, and the results indicated the device is "functional within its intended use," but this is a general statement and not a detailed study proving specific acceptance criteria are met.
• No information on test set sample size, data provenance, ground truth establishment, or adjudication method: Since no clinical study or formal test set evaluation is presented in the document, these details are not available.
• No MRMC comparative effectiveness study: The document does not describe any study involving human readers and AI assistance.
• No standalone (algorithm only) performance study: The device is a physical femoral component, not an algorithm. Therefore, a standalone algorithm performance study is not applicable.
• Type of ground truth: Not applicable as no clinical study or performance evaluation with ground truth is described.
• Training set sample size: Not applicable as this is a physical device, not an AI/algorithm-based product requiring a training set in the conventional sense.
• How ground truth for training set was established: Not applicable for the same reason mentioned above.

In summary, this document is a regulatory submission for a physical medical device and does not contain the type of information requested regarding acceptance criteria and performance studies typically associated with AI/algorithmic medical devices.

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