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This device, an all-polyethylene concentric dome patella, is intended to be used with the femoral and tibial components of the Duracon® and P.C.A.® MTK II components as a total knee system. This component is intended to be used in the primary and/or revision replacement of the articular surface of the patella.

This device, an all-polyethylene concentric dome patella, is intended to be used with the femoral and tibial components of the Duracon® and P.C.A.® MTK II components as a total knee system. This component is intended to be used in the primary and/or revision replacement of the articular surface of the patella.

This document is a 510(k) summary for a medical device (Duracon® Inset Patella with Central Peg). It describes the device, its intended use, and its similarities to other legally marketed devices. However, it does not contain the detailed information required to answer your specific questions about acceptance criteria, study design, and performance metrics.

Here's why and what information is missing based on the prompt's requirements:

Missing Information and Why:

1. A table of acceptance criteria and the reported device performance: The document states "Patello-femoral contact area and shear testing were presented, with a comparison to a legally marketed device." However, it does not provide the specific acceptance criteria (e.g., minimum contact area, maximum shear force, statistical thresholds) or the actual reported device performance values for either the Duracon® Inset Patella or the comparator device.
2. Sample size used for the test set and the data provenance: There is no mention of a "test set" in the context of clinical or performance data. The "testing" mentioned is mechanical. Therefore, there's no information on sample size, data country, or retrospective/prospective nature.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This type of information is relevant for studies involving human interpretation (e.g., image analysis). Since the testing mentioned is mechanical (patello-femoral contact area and shear testing), this concept of "experts establishing ground truth" for a test set is not applicable.
4. Adjudication method for the test set: Similar to point 3, adjudication methods are for human interpretation tasks. Not applicable here.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done... effect size: MRMC studies are typically for evaluating diagnostic or interpretive tools where multiple human readers assess cases. This device is a knee implant, so an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: "Standalone performance" refers to the performance of an algorithm or AI without human intervention. This is not an AI/algorithm device; it's a physical implant.
7. The type of ground truth used: For mechanical testing, the "ground truth" would be the direct measurements obtained from the physical tests (e.g., force transducers, pressure sensors, optical tracking for contact area). The document only generally mentions what was tested ("Patello-femoral contact area and shear testing") but not the specific methods or the "ground truth" definition.
8. The sample size for the training set: This concept applies to AI/machine learning models. This is a physical medical device.
9. How the ground truth for the training set was established: Not applicable for a physical medical device.

In summary: The provided text is a regulatory summary for a medical device, focusing on its equivalence to previously marketed devices based on design, materials, and mechanical testing. It does not present the detailed statistical or clinical study results, acceptance criteria, or ground truth establishment methods that would be relevant for an AI/diagnostic device's performance evaluation. The questions you posed are largely framed for AI or diagnostic software, not a physical implant.

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