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The Optetrak Femoral components are intended to replace the patient's distal femur during primary or revision total knee arthroplasty. The Optetrak® Asymmetric Femoral components are intended for use when needed to more closely match the geometry of the patient's resected distal femur. This change results in separate components for the right and left knees. The Asymmetric, Cruciate-Retaining Cemented components and the Asymmetric, Cruciate-Retaining, Porous-Coated Femoral Components are intended for use in total knee arthroplasty procedures in which the Posterior Cruciate Ligament (PCL) is preserved.

The Optetrak® Size 6 Posterior-Stabilizing, Cemented Femoral Component and Asymmetric, Posterior-Stabilizing Femoral components are intended to replace the function of the PCL during a total knee arthroplasty in which the PCL must be sacrificed.

All proposed femoral components are intended for cemented use only.

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 posterior stabilized, cruciate-retaining cemented, and cruciate-retaining porous coated femoral components of the Optetrak® Total Knee System (K932690, K933494, K935726, K011976). These changes include:

1. Modification of the patellar flange to create an asymmetric femoral component
2. Addition of a larger size posterior-stabilized, cemented (symmetric) femoral component

No changes were made to the tibial or patellar components of the Optetrak® Total Knee System.

The differences in design features between the proposed Optetrak AK Femoral and predicate Optetrak® Femoral include the following:

1. Changes to the anterior flange to make the component asymmetric by:
   a. Tilting the flange laterally, and
   b. Angling the proximal edge of the flange medially.
2. Adjustments to the patella groove edges by:
   a. Increasing the edge radii resulting from the intersections of the patella groove and the trochlear condyles to smooth the edges, and
   b. Slightly lowering the profile height of the medial trochlear condyle in the proximal area as a result of the tilting of the flange.

The difference in design between the proposed size 6 femoral component and the predicate femoral components consists of a size increase in the overall geometry of the component. resulting in:

1. An increase in the overall anterior-posterior dimension of four (4) millimeters
2. An increase in the overall medial-lateral dimension of five (5) millimeters

The provided text describes a Special 510(k) submission for a line extension of the Exactech® Optetrak® Total Knee System, specifically for Optetrak® Femoral Components. This submission is for modifications to existing devices, not for a new medical imaging or diagnostic device that would involve an AI algorithm with specific acceptance criteria related to accuracy, sensitivity, or specificity.

Therefore, the document does not contain the information required to answer your request. The "acceptance criteria" discussed are related to demonstrating substantial equivalence to predicate devices for mechanical performance and design changes, rather than clinical performance metrics for an AI-powered diagnostic tool. The "study" mentioned refers to "Verification and Validation analyses" for implant performance, which are likely mechanical and design tests, not clinical studies with human participants, ground truth establishment, or statistical performance metrics.

Specifically, the following information is not present in the provided text:

1. A table of acceptance criteria and the reported device performance: The document does not specify quantitative clinical acceptance criteria or performance metrics in terms of accuracy, sensitivity, specificity, or similar.
2. Sample size used for the test set and the data provenance: No information about a clinical test set, its sample size, or data provenance is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not applicable as there is no clinical test set with an associated ground truth based on expert review.
4. Adjudication method for the test set: Not applicable.
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, as this is not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document primarily focuses on:

• The sponsor and contact information (Exactech Inc.).
• The device name and its classification.
• The legally marketed predicate devices for substantial equivalence comparison.
• The intended use, indications, and contraindications of the Optetrak Femoral components.
• Specific device modifications:
  • Modification of the patellar flange to create an asymmetric femoral component.
  • Addition of a larger size posterior-stabilized, cemented (symmetric) femoral component.
• A general statement about "PERFORMANCE DATA SUMMARY": "Verification and Validation analyses were conducted to verify that the implant performance would be adequate for anticipated in vivo loading." The conclusion is that the modified components are "substantially equivalent" to the predicate devices.

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