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The EVOS Mini Plating System, excluding EVOS Patella Plates, is indicated for patients 12 – 21 and those over 21 years of age, as well as patients with osteopenic bone. The Smith & Nephew EVOS Mini Plating System is indicated for fracture fixation or reduction of small bones and small bone fragments. This system is also indicated for non-load bearing stabilization of bone fragments in long bones.

The EVOS Patella Plates are indicated for the fixation of patellar fractures for patients over 21 years of age.

The subject EVOS Patella Plates are an extension to the EVOS Mini Fragment system previously cleared under K140814 (S.E. 5/7/2014). The subject bone plates consist of a Staggered Patella Plate, and a Small and Large Mesh Patella Plate. The subject plates are compatible with the previously cleared EVOS 2.7mm locking screws, and partially and fully threaded 4.0mm osteopenia screws (K140814). The proposed plates feature a variable angle locking screw hole feature, are manufactured from implantgrade 316L Stainless Steel material and will be available in a sterile packaged condition.

The provided text describes a 510(k) premarket notification for the "EVOS Patella Plates" and does not contain information about acceptance criteria or a study proving device performance against such criteria. The document is a letter from the FDA confirming substantial equivalence to predicate devices, and a 510(k) summary.

It lists the following nonclinical tests performed:

• Finite element analysis (FEA)
• Four Point Bend Fatigue performance evaluation
• Magnetic resonance imaging (MR) compatibility evaluation per ASTM F2213, ASTM F2182, and ASTM F2119
• Packaging verification testing per ASTM F2096 and ASTM F88

However, it does not provide:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for test sets, data provenance, number of experts for ground truth, or adjudication methods.
3. Information on a multi-reader, multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.
4. Type of ground truth used (as these are physical devices, ground truth in the context of diagnostic performance is not applicable).
5. Sample size for the training set or how ground truth for the training set was established.

The document states that Finite Element Analysis (FEA) and predicate clinical data were leveraged to support device performance, suggesting that a specific study proving the EVOS Patella Plates meet defined acceptance criteria beyond the listed non-clinical tests is not detailed within this submission. The focus of a 510(k) summary is to demonstrate substantial equivalence to a predicate device, rather than to present a de novo study proving novel performance criteria.

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