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The Unicompartmental Knee is solely indicated for medial compartment replacement of the articulating surface of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty procedures. This device is intended for cemented use only.

The VOT Uni Knec consists of a femoral and a tibial component. The low profiled prosthesis is designed to be nonconstraining and to allow natural weight distribution and flexion. The anatomically designed femoral component is asymmetrically shaped conforming to the natural knee in the coronal and sagittal planes. The post and keel are designed to provide anteroposterior and mediolateral stability. Cobalt Chrome Alloy is used to fabricate the component which is available in three sizes. The tibial component is manufactured from Ultra-High Molecular Weight Polyethylene (UHMWPe). It incorporates a hemispherical shaped articular surface to replicate the natural knce. The component is nonconstraining and designed to allow natural weight distribution and flexion. Dovetailed channels on the undersurface allow for mechanical lock between the implant and the cement mantle. The thickness of the component under the area of the femoral-tibial articulation helps to improve longevity and to minimize the possibility of its fracture. The dual injection ports, the cement delivery instruments, synnge and adapter facilitate cement application. Nine sizes are available to enhance surgical latitude in preoperative planning. Tibial and femoral instruments and trials are also available to facilitate implantation.

I am sorry, but based on the provided text, there is no information about an acceptance criteria or a study that proves the device meets any specific criteria.

The document is a 510(k) summary for a medical device (Unicompartmental Knee) and primarily focuses on:

• Applicant/Sponsor Information
• Proprietary and Common Name of the Device
• Classification Name and Number
• Legally Marketed Predicate Devices (to which substantial equivalence is claimed)
• Device Description
• Indications for Use
• FDA's 510(k) clearance letter, indicating substantial equivalence to predicate devices.

The FDA 510(k) clearance process primarily relies on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring the submission of new clinical studies with specific performance acceptance criteria like those often seen for novel devices or PMAs.

Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, or training set details, as this information is not present in the given text.

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