(28 days)
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:
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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.
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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.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Given that no clinical testing was performed, an MRMC study was also not conducted.
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Standalone Performance: Not applicable, as no standalone clinical performance study was conducted.
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Ground Truth Type: Not applicable, as no clinical study was performed that would require ground truth.
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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."
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.