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Joint replacement is indicated for patients suffering from disability due to:

· degenerative, post-traumatic or rheumatoid arthritis;

· avascular necrosis of the femoral condyle;

· post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy;

· moderate valgus, varus or flexion deformities;

· treatment of fractures that are unmanageable using other techniques.

This device may also be indicated in the salvage of previously failed surgical attempts. All devices are intended for cemented applications except for the FOUNDATION® Porous Coated Femur, FOUNDATION® Porous Coated Tibia Stemmed, FK/3DKNEE™ Porous Coated Downsize Tibia, 3DKNEE™ Porous Coated Femur, 3DKNEE™ Porous Coated Tibia, EMPOWR Porous® Knee Femur, EMPOWR Porous® Knee Tibia and Patella - Metal Backed which are intended for cementless applications.

While knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.

The Porous Patella e+TM is a sterile, single-use, non-modular metal-backed patella that is manufactured from moderately crosslinked UHMWPE blended with Vitamin E and titanium alloy. The device is offered in a symmetric, domed, design available in multiple sizes. The device is intended for cemented or uncemented applications.

Non-sterile surgical instruments are supplied with the implant.

The provided text describes a 510(k) premarket notification for the "Porous Patella e+™" device. This is a medical device submission, and the content focuses on regulatory approval rather than the results of a study demonstrating the device meets a specific set of acceptance criteria in a clinical setting.

Therefore, the input document does not contain the acceptance criteria or a study proving the device meets said criteria in the context of clinical performance or diagnostic accuracy.

The "Non-clinical Testing" section lists various types of engineering and material tests performed to demonstrate the device's substantial equivalence to a predicate device, which is a different type of evaluation from a clinical study for acceptance criteria.

Here's the breakdown of why the requested information cannot be fully provided based on the given text:

• Acceptance Criteria and Reported Device Performance: This document describes the device (Porous Patella e+™) and its indications for use, and then lists engineering tests performed to show substantial equivalence to a predicate device. It does not provide specific acceptance criteria related to a clinical outcome or diagnostic performance, nor does it report device performance against such criteria. The tests mentioned (e.g., Chemical Composition, Stereological Evaluation, Mechanical Properties, Abrasion, Initial Implant Stability, Durability) are laboratory-based engineering evaluations.
• Sample size for the test set and data provenance: Not applicable. No clinical test set is described.
• Number of experts used to establish ground truth & qualifications: Not applicable. No ground truth for a test set is discussed.
• Adjudication method: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: The document explicitly states "Clinical testing was not required" and "No animal data submitted." Therefore, no MRMC study was performed or is reported.
• Standalone performance: Not applicable. This refers to algorithm-only performance, and the device is a physical medical implant, not an algorithm.
• Type of ground truth used: Not applicable.
• Sample size for the training set: Not applicable, as there's no machine learning algorithm described.
• How the ground truth for the training set was established: Not applicable.

In summary, the provided FDA 510(k) document is a regulatory submission focused on demonstrating substantial equivalence through non-clinical (engineering and materials) testing for a physical implant, not a clinical study to establish performance against acceptance criteria typically associated with diagnostic or therapeutic effectiveness in a human population.

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