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The Signature Orthopaedics' TLC Unicompartmental Knee comprising the femur component, tibial component and meniscal inserts is designed for a single compartment of the natural knee joint. The TLC Unicompartmental Knee is indicated for cemented use in partial knee arthroplasty procedures. Partial replacement of the articulating surfaces of the knee is indicated only when only one compartment of the joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty.

The TLC Unicompartmental Knee system is a modular knee system consisting of a femoral component, meniscal insert and a tibial baseplate. The femoral component is manufactured from cast cobalt chromium alloy and are intended for use with bone cement. The tibial baseplate component is manufactured from titanium alloy and intended for use with bone cement. The meniscal insert is manufactured from UHMWPE.

This document is an FDA 510(k) clearance letter for a medical device (TLC Unicompartmental Knee System). It grants the manufacturer permission to market the device based on its substantial equivalence to previously cleared predicate devices.

Crucially, this document does not contain information about acceptance criteria or a study proving the device meets those criteria (e.g., performance metrics, sample sizes, ground truth establishment, or multi-reader studies).

The "Performance Testing" section lists the types of non-clinical tests performed (e.g., Range of motion analysis, Tibial plate fatigue testing), but it does not provide any specific acceptance criteria or the results of these tests. It merely states that "Non-clinical testing and engineering evaluations were conducted to verify that the performance of the TLC UniKnee system is adequate for anticipated in-vivo use."

Therefore, I cannot extract the information required to populate the requested table and answer the questions directly from the provided text. The document focuses on regulatory clearance based on substantial equivalence, not on a detailed clinical or performance study demonstrating specific achievement of acceptance criteria.

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