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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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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.

This system is to be used for cemented applications

The purpose of this application is to include a new domed design patella for the Foundation and 3DKnee systems manufactured with both the standard UHMWPE and highly crossed linked UHMWPE infused with Vitamin E.

The provided document K121835 is a 510(k) summary for a medical device (Domed Tri-Peg Patella), which is a premarket submission to the FDA. This type of submission is for demonstrating substantial equivalence to a predicate device, not typically for establishing new acceptance criteria and proving performance through a clinical study in the way a PMA (Premarket Approval) submission would.

In this specific 510(k) summary:

• Acceptance Criteria and Reported Device Performance: This information is not provided in the context of the requested table. A 510(k) summary focuses on demonstrating equivalence to predicate devices, primarily through non-clinical testing for mechanical properties and material compatibility, rather than setting and meeting specific clinical performance acceptance criteria. The document states "Non-Clinical Testing: Previous mechanical testing outlined in K113756 demonstrated the device's ability to perform under expected conditions. Testing included mechanical characterization testing, push out, lever out, torsion, Izod impact, small punch, tensile, FTIR, wear, animal implant for toxilogical response, and cytotoxicity." These are general mechanical and biocompatibility tests, not specific clinical acceptance criteria for diagnostic accuracy or effectiveness.

• Clinical Testing: The document explicitly states: "Clinical Testing: None provided." This means no human subject study was conducted to establish new clinical performance or acceptance criteria for this specific device in this submission. Therefore, none of the subsequent questions related to clinical study design, sample size, ground truth, or expert involvement can be answered from this document.

• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Given that no clinical testing was performed, an MRMC study was also not conducted.

• Standalone Performance: Not applicable, as no standalone clinical performance study was conducted.

• Ground Truth Type: Not applicable, as no clinical study was performed that would require ground truth.

• Training Set Sample Size and Ground Truth Establishment (for a clinical study): Not applicable, as no clinical study was performed.

In summary, the provided 510(k) document is for a device seeking substantial equivalence based on prior predicate device testing and non-clinical mechanical/material testing. It does not contain information on acceptance criteria and a study proving the device meets those criteria in a clinical context, as explicitly stated by "Clinical Testing: None provided."

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