(57 days)
The Exactech® Optetrak Logic® CC 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.
The Exactech® Optetrak Logic® CC is indicated for cemented use only.
Optetrak Logic CC is a cemented total knee prosthesis system that provides femoral components, tibial inserts, stems, augments, and surgical instrumentation for use in primary and revision total knee arthroplasty. Like corresponding predicate Optetrak CC system femoral components and tibial inserts, Optetrak Logic CC femoral components and tibial inserts are constrained condylar prostheses featuring an increased level of constraint compared to other Optetrak and Optetrak Logic knee system devices. Optetrak Logic CC also provides various stem extensions and augment blocks surgeons can use to address bone defects and bone loss.
The provided text is a 510(k) premarket notification for the Exactech® Optetrak Logic® CC knee prosthesis. This document does not contain the detailed information requested regarding acceptance criteria and the study proving the device meets them.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Information on sample size, data provenance, number or qualifications of experts, or adjudication methods for any test set.
- Details on a multi-reader multi-case (MRMC) comparative effectiveness study or any effect sizes.
- Information on standalone algorithm performance.
- The type of ground truth used, sample size for the training set, or how ground truth for the training set was established.
Instead, the document primarily focuses on:
- Regulatory approval: It is a letter from the FDA determining substantial equivalence to predicate devices.
- Device description: It describes the Exactech® Optetrak Logic® CC as a cemented total knee prosthesis system with various components.
- Intended use: It specifies the indications for use in skeletally mature individuals for total knee replacement due to various conditions and for revision surgery.
- Substantial Equivalence: It claims substantial equivalence to existing cleared Exactech Optetrak devices.
- Testing referenced: It mentions "mechanical testing" including "Constraint testing" and "Stem extension fatigue testing" but does not provide results, acceptance criteria, or details of these tests within the provided text. The statement "Results of engineering studies referenced in this 510(k) submission demonstrate proposed Optetrak Logic CC Total Knee System devices are substantially equivalent to cited cleared predicate Optetrak devices" is a conclusion of testing, not a detailed report of the testing itself.
Therefore, I cannot provide the requested information based on the given text.
§ 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.