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Partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, deformity or revision of previous arthroplasty. The device is a single use implant intended for implantation with bone cement.

The Oxford™ Unicompartmental Knee Femoral Component has a highly polished spherical articular surface. The inner surface of the prosthesis is, for the most part, spherically concave and concentric with the articular surface. Posteriorly there is a small, flattened surface, the plane of which lies parallel to the long axis of the femur. There is a central peg. This ped lies parallel to the mechanical axis of the femur. The component is available in four distinct sizes to allow for fit to patient anatomy.
Two styles of Repicci™ tibial components may be used with the Oxford™ Unicompartmental Knee Femoral Component, an all polyethylene component and a modular metal backed component.

The provided text is a 510(k) premarket notification for a medical device, specifically the Oxford™ Unicompartmental Knee Femoral Component. It describes the device, its intended use, and states that substantial equivalence is claimed based on similar or identical technological characteristics to predicate devices. Crucially, the document explicitly states "Non-Clinical and Clinical Testing: None provided as a basis for substantial equivalence."

Therefore, a detailed description of acceptance criteria, a specific study proving the device meets those criteria, or information on reader studies, ground truth establishment, or sample sizes for training/test sets cannot be extracted from this document, as such studies were not performed or submitted as part of this particular 510(k) application for substantial equivalence.

Here's a breakdown of why the specific questions cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance: Not provided. The submission states "Non-Clinical and Clinical Testing: None provided as a basis for substantial equivalence."
2. Sample sizes used for the test set and the data provenance: Not applicable, as no clinical testing data was provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical testing data was provided.
4. Adjudication method: Not applicable, as no clinical testing data was provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a physical implant, not an AI-assisted diagnostic tool. No such study was mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used: Not applicable, as no clinical testing data was provided.
8. The sample size for the training set: Not applicable, as no clinical testing data was provided.
9. How the ground truth for the training set was established: Not applicable, as no clinical testing data was provided.

The core of this 510(k) submission relies on demonstrating substantial equivalence to already legally marketed predicate devices (Repicci™ II Unicondylar Knee K971938 and AGC® Unicompartmental Femoral Component K873601) based on similar or identical materials, design, sizing, and indications for use, rather than presenting new clinical performance data. The only testing mentioned is "Engineering analysis conducted to show strength of peg," which is a non-clinical, mechanical test, not a clinical study to establish acceptance criteria or performance metrics directly comparable to the questions asked.

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