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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.

In the USA, the OPTETRAK Logic Total Knee System is indicated for cemented use only.

Proposed Optetrak Logic CR Knee System femoral components are modifications to existing femoral components cleared per Optetrak Cruciate Retaining Cemented Total Knee System 510(k) #K932690 and Optetrak Logic Total Knee System 510(k) #K093360.

Proposed Optetrak Logic CR Knee System tibial inserts are modifications to existing tibial inserts cleared per Optetrak Cruciate Retaining Cemented Total Knee System 510(k) #K932690 and Optetrak CR Slope 510(k) #K082022.

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 .
• the same design features .
• . the same materials
• the same shelf life .
• . packaging and sterilization using the same materials and processes
• compatible with the same corresponding Optetrak tibial trays ●

The Optetrak Logic CR Knee System is not being submitted as the result of a recall or any corrective action related to the Optetrak product lines.

The provided document describes the Exactech® Optetrak® Logic® CR Knee System, a cemented total knee prosthesis. The submission is a Special 510(k) and focuses on demonstrating substantial equivalence to previously cleared predicate devices.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, measurable format with pass/fail thresholds. Instead, the performance evaluations are centered around demonstrating substantial equivalence to existing predicate devices. The "performance data" table describes the activities performed to support this claim.

The overall acceptance criterion is based on demonstrating substantial equivalence to the predicate devices. The reported "performance" is that the results of the engineering studies demonstrate substantial equivalence.

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

The document describes engineering evaluations (drawing comparisons and Finite Element Analysis), not a test set in the traditional sense of human subjects or clinical data. Therefore, there is no sample size for a test set, nor is there information on data provenance (country of origin, retrospective/prospective) as these evaluations are based on design specifications and simulation, not patient data.

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

No experts were used to establish ground truth in the context of a test set, as the evaluations were engineering-based rather than involving diagnostic interpretation or clinical outcomes. The "experts" in this context would be the engineers performing the drawing comparisons and finite element analysis, but their qualifications and numbers are not specified.

4. Adjudication Method for the Test Set

Not applicable. There was no test set requiring adjudication in the medical or clinical sense. The comparisons and analyses are engineering-based.

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 prosthesis, not an AI-assisted diagnostic tool. Therefore, an MRMC study and AI-related improvement metrics are irrelevant to this submission.

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

Not applicable. This device is a physical medical implant, not an algorithm or software.

7. The Type of Ground Truth Used

The "ground truth" in this context is the design specifications and performance characteristics of the predicate devices. The new device's design, compatibility, and mechanical properties were compared against these established predicates to demonstrate equivalence.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning model, so there is no training set.

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

Not applicable, as there is no training set for this device.

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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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