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The OPTETRAK Comprehensive 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. In the USA, the OPTETRAK Comprehensive Knee Systems are indicated for cemented use only, except for the OPTETRAK Logic PS and CR Porous Femoral Components, which are indicated for cemented or cementless use.

Subject Optetrak Logic Porous Femoral Component devices are the same devices as Optetrak Logic Porous Femoral Components cleared per K123687. The purpose of this submission is to expand the indications for use for these devices to provide surgeons with the option for using them without bone cement, as with predicate devices cleared per 510(k) submission K062654.

The provided text does not contain information about acceptance criteria for a medical device's performance that would typically be evaluated through clinical studies involving human patients or imaging modalities. Instead, it details a 510(k) submission for a femoral knee prosthesis, focusing on demonstrating substantial equivalence to previously cleared devices.

The acceptance criteria mentioned are related to engineering and material properties, rather than diagnostic performance metrics. Specifically, the summary states:

Acceptance Criteria and Reported Device Performance:

No information is available regarding the following points as they are not relevant to this type of 510(k) submission, which focuses on material and engineering equivalence, not AI or clinical performance studies:

• Sample size used for the test set and the data provenance.
• Number of experts used to establish the ground truth for the test set and their qualifications.
• Adjudication method for the test set.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done.
• If a standalone (algorithm only without human-in-the-loop performance) was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• The sample size for the training set.
• How the ground truth for the training set was established.

Summary of the Study:

The study described is an engineering study and material analysis to demonstrate that the Exactech® Optetrak Logic® Porous Femoral Component is substantially equivalent to predicate devices. The purpose was to expand the indications for use to include cementless application.

The methods involved:

• Characterization of porosity, pore size, and coating thickness according to ASTM F1854-09.
• Analysis of chemical composition and material microstructure.

The conclusion drawn was that the results of these engineering studies demonstrated the proposed device's substantial equivalence to the cited cleared predicate devices (K123687 and K062654). This approach is typical for devices seeking 510(k) clearance based on demonstrating equivalence in design, materials, and mechanical properties, especially for an expanded indication for a previously cleared device.

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