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The Offset Tibial Tray components are intended to replace the patient's proximal tibia during primary or revision total knee arthroplasty. The Optetrak Offset Tibial Tray is intended for use when the tibial intramedullary (IM) canal is offset from the tibial plateau.

The OPTETRAK® Total Knee Systems are 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 device modifications presented in this Special 510(k) represent changes to the Tibial Tray Components of the Optetrak Total Knee System (premarket notifications #K933610 and #K011976). No changes were made to the other components of the Optetrak Total Knee System.

The proposed device modifications involve offsetting the distal portion of the tray's stem in the sizes 0, 1 Delta, 1, 2, 3, 4 and 5. This is done in order to accommodate varying patient anatomies.

No modifications have been made to the mating features of the Tibial Tray in order to maintain the full mating capabilities with all tibial inserts, augmentation components and stem extensions of the predicate Optetrak Total Knee System

The proposed offset design incorporates modified screws for attachment of the Constrained Condylar Tibial Inserts and the Tibial Stem Extensions.

There have been no changes to the material of the predicate Optetrak Tibial Tray components. Like the predicate Optetrak Tibial Tray components (#K933610 & #K011976), the proposed tray components are manufactured from titanium alloy (Ti 6 Al 4V) conforming to ASTM F-136.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance for the Exactech® Optetrak® Total Knee System Line Extension - Offset Tibial Tray Special 510(k)

This document describes a Special 510(k) submission for modifications to an existing device, the Optetrak Total Knee System. The primary modification involves offsetting the distal portion of the tibial tray's stem. For such submissions, the acceptance criteria are typically met by demonstrating that the modified device is substantially equivalent to the predicate device and that the modifications do not negatively impact its safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not specify a sample size for a test set in the context of clinical data for the Offset Tibial Tray. This is because the submission is a Special 510(k) for a device modification, relying heavily on predicate device equivalence and bench testing rather than new clinical trials.

The data provenance for the "Functional testing" is not explicitly stated (e.g., country of origin, retrospective or prospective), but it would be laboratory-based (bench testing), not clinical.

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

This information is not applicable or provided in the context of this Special 510(k) submission. The "ground truth" here is established through mechanical testing standards and comparison to the predicate device's performance, not by expert review of patient data.

4. Adjudication Method for the Test Set

This information is not applicable or provided. Since the primary performance data comes from functional (bench) testing, there would be no need for an adjudication method as typically applied to expert-reviewed clinical or imaging data.

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

There was no MRMC comparative effectiveness study done, as this is a mechanical medical device (a knee implant), not an AI-powered diagnostic tool. The concept of "human readers" and "AI assistance" is not relevant to this device.

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

This is not applicable or provided. This device is a mechanical implant, not an algorithm, so a "standalone algorithm" performance assessment is irrelevant.

7. The Type of Ground Truth Used

For this Special 510(k) submission concerning a mechanical device modification, the "ground truth" for demonstrating safety and effectiveness is primarily based on:

• Mechanical performance standards and established engineering principles: Ensuring the modified implant can withstand anticipated in vivo loads.
• Material specifications: Conformance to ASTM standards (ASTM F-136 for Ti 6 Al 4V).
• Demonstrated performance of the predicate device: The new design is compared to the known and accepted performance of the legally marketed predicate Optetrak products.

Thus, the ground truth is derived from bench testing results and material compliance, not pathology, patient outcomes, or expert consensus on clinical data for the modified component itself.

8. The Sample Size for the Training Set

This information is not applicable or provided. As this is a mechanical medical device, there is no "training set" in the context of machine learning or AI. The design and testing are based on engineering principles and predicate device data.

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

This information is not applicable or provided for the same reasons as in point 8.

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