(30 days)
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.
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.