Search Results

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.

The Optetrak Logic Total Knee System is indicated for cemented use only.

The proposed Optetrak Logic. Total Knee System half-size finned and trapezoidal tibial trays are modifications to the existing Optetrak Total Knee System Cruciate Retained Titanium Back Tibial. Components (K932776) and Optetrak Total Knee Trapezoidal Cemented Tibial Components (933610), respectively. The proposed Optetrak Logic Total Knee System tibial inserts and femoral components are modifications to the existing Optetrak Total Knee System Hi-Fiex Knee Components (K033883).

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 .
• similar design features .
• . incorporate the same materials
• the same shelf life .
• . are packaged and sterilized using the same materials and processes.

This document describes a 510(k) submission for the Exactech® Optetrak® Logic™ Total Knee System. 510(k) submissions, particularly for orthopedic implants like knee systems, typically rely on equivalence to predicate devices and engineering studies rather than clinical trials with human subjects to prove performance and safety. As such, the information requested about acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and MRMC studies often does not apply in the context of a Special 510(k) for device modifications like this one.

Based on the provided text, here's a breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly stated in the provided text. For a device like this, acceptance criteria would typically involve demonstrating mechanical and material equivalence to the predicate devices through engineering studies (e.g., fatigue testing, wear testing, mechanical strength, dimensional conformity to design specifications). The reported device performance would be that it meets these criteria, thereby establishing substantial equivalence.

2. Sample Sizes Used for the Test Set and Data Provenance

Not applicable in the context of this 510(k) Preamble. This submission is for modifications to an existing knee system and relies on engineering studies, not clinical trials with "test sets" of patients.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. Ground truth as typically understood for diagnostic or AI-based devices (e.g., consensus of radiologists on images) is not relevant for this type of implantable device submission. The "ground truth" here would be the established performance characteristics and safety profile of the predicate devices, and the engineering principles demonstrating the modified device performs equivalently.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" of patient data that would require medical expert adjudication in this type of submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a knee implant, not an AI diagnostic or assistance tool, so MRMC studies are not relevant.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is a physical knee implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate devices through their prior clearances and long-term clinical use. The new device demonstrates "substantial equivalence" to these predicates. The types of evidence used to demonstrate this include:

• Similar indications for use.
• Similar design features.
• Incorporation of the same materials.
• Same shelf life.
• Same packaging and sterilization processes.
• Results of engineering studies. These studies would confirm that the modifications do not adversely affect the mechanical performance, wear characteristics, or other critical safety and performance attributes compared to the predicate device.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device; there is no "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable. There is no "training set" for this device.

Summary of the Study and Acceptance Criteria from the Provided Text:

The provided document is a 510(k) Summary of Safety and Effectiveness for a Special 510(k). This indicates that the device being submitted (Exactech® Optetrak® Logic™ Total Knee System) involves modifications to existing, already cleared predicate devices.

The core of the submission relies on demonstrating Substantial Equivalence to the predicate devices. The study proving this is explicitly mentioned as:

• "Results of engineering studies referenced in this 510(k) submission demonstrate the proposed Optetrak Logic Total Knee System devices are substantially equivalent to cited cleared predicate devices."

The "acceptance criteria" are therefore implicitly that the results of these engineering studies confirm the modified device maintains the same safety and effectiveness profile as the predicate devices, despite the modifications. The specific details of these engineering studies (e.g., fatigue tests, wear tests, material property analyses) and their numerical acceptance thresholds are not provided in this summary document but would be reviewed by the FDA as part of the full submission.

The document highlights the basis for substantial equivalence:

• The same indications for use.
• Similar design features.
• Incorporate the same materials.
• The same shelf life.
• Are packaged and sterilized using the same materials and processes.

This document serves as a high-level summary, and the detailed engineering study reports would contain the specific acceptance criteria and detailed performance data.

Ask a specific question about this device