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The Optetrak Logic Total Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/or post-traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.

In the USA, the OPTETRAK Logic Total Knee System is indicated for cemented use only.

Proposed size 0 and size 6 Optetrak Logic CR Knee System components are line extensions to the Optetrak Logic CR Knee System cleared per 510(k) #K111400.

The predicate and proposed devices have the same intended use and basic fundamental scientific technology and share the following similarities:

• the same indications for use .
• . the same design features
• the same materials .
• . the same shelf life
• packaging and sterilization using the same materials and processes .
• compatible with the same corresponding Optetrak Logic tibial trays .

The size 0 and 6 Optetrak Logic CR Knee System components are not being submitted as the result of a recall or any corrective action related to the Optetrak product lines.

This document describes a 510(k) submission for a medical device, specifically a knee replacement system, and does not involve any AI/ML components or software. Therefore, the request to describe acceptance criteria and a study proving device performance in the context of AI/ML is not applicable to this input.

The document focuses on demonstrating substantial equivalence of new sizes (0 and 6) of the Exactech® Optetrak® Logic® CR Knee System to a previously cleared predicate device (K111400). The "Performance Data" section explicitly states that mechanical testing was used to assess and compare peak contact pressures, implying physical testing of the knee implant components rather than an AI/ML algorithm.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details as these concepts are specifically related to the evaluation of AI/ML-driven devices.

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