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Joint replacement is indicated for patients suffering from disability due to:
• degenerative, post-traumatic or rheumatoid arthritis;
• avascular necrosis of the femoral condyle;
• post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy;
• moderate valgus, varus or flexion deformities;
• treatment of fractures that are unmanageable using other techniques.
This device may also be indicated in the salvage of previously failed surgical attempts. This system is to be used for cemented applications.
Exprt Revision Knee Femoral Augments are also to be attached to the femoral component with bone cement.

This Special 510(k) is to add additional components to the currently cleared Exprt Revision Knee. These components are as described as follows:
A 5mm thick, machined, Ti alloy, distal femoral augment which will be available in 4 sizes. The augment covers either the posterior femoral resection in a horizontal orientation or the distal femoral resection in a vertical orientation and fits within the cement pocket of the femoral component.
A shorter cemented stem extension for use with both the tibial base plate and the femoral component. The stem, made from CoCrMo alloy, is fluted along its length for rotational constraint when cemented. The stem is available in a 40mm long, straight configuration.

The provided text is a 510(k) premarket notification for knee joint components (EXPRT Knee Femoral Augment and EXPRT Revision Knee Stem Extension). This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than comprehensive de novo clinical studies with acceptance criteria or ground truth establishment as might be seen for novel AI/ML medical devices.

Therefore, many of the requested categories are not applicable to this document. I will fill in the information that is available and indicate when a category is not applicable based on the nature of this submission.

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not Applicable. This submission relies on substantial equivalence through non-clinical testing (drawing review, tolerance stack-ups, anatomic bone model evaluation) rather than a statistical test set of clinical cases.
• Data Provenance: Not Applicable. No human data (clinical or image-based) test set was used. The "anatomic bone model evaluation" likely refers to in-vitro testing or simulations rather than patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. No ground truth was established by experts for a test set in the context of this 510(k) submission. Design and engineering expertise would have been implicitly involved in the "drawing review with tolerance stack ups" and "anatomic bone model evaluation."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. No test set requiring expert adjudication was used.

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 not an AI/ML diagnostic or assistive tool, so an MRMC study is irrelevant.

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 (expert consensus, pathology, outcomes data, etc)

• Not Applicable. The concept of "ground truth" in the context of a diagnostic or predictive device does not apply to this physical implant. Equivalence was demonstrated through engineering analyses and material testing against established standards and predicate device characteristics.

8. The sample size for the training set

• Not Applicable. This device is a physical implant, not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established

• Not Applicable. No training set or associated ground truth was established for this device.

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Joint replacement is indicated for patients suffering from disability due to:

• degenerative, post-traumatic or rheumatoid arthritis; .
• avascular necrosis of the femoral condyle; .
• post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, . dysfunction or prior patellectomy;
• moderate valgus, varus or flexion deformities; .
• treatment of fractures that are unmanageable using other techniques. .

The patient's joint must be anatomically and structurally suited to receive the selected implant(s).

This device may also be indicated in the salvage of previously failed surgical attempts. This system is to be used for cemented applications

The Exprt Revision Knee (ERK) is a tri-compartmental posterior stabilized knee for cemented applications. The system is comprised of three primary components: Femur, Tibial Insert, and Tibial Baseplate. The system is intended to treat patients who are candidates for revision total knee arthroplasty or difficult primary arthroplasty where bone loss may be substantial and the collateral ligaments may be compromised. The design of the knee system is a total condylar design, increasing sagittal conformity and stability. The post and cam of the posterior stabilized design are crucial to inducing femoral rollback and providing resistance to tibial subluxation, substituting the function of the absent PCL. The tibial post, in combination with the femoral cam, provides for greater patient flexion by forcing the femur posteriorly on the tibia.

Here's a breakdown of the acceptance criteria and the study information for the "Exprt Revision Knee" device, as extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

• Static contact area/contact stress testing
• Static testing in anterior-posterior draw
• Static testing in rotary laxity
• Patella subluxation evaluation |

Note: The document does not provide specific numerical acceptance criteria or performance metrics (e.g., minimum load bearing capacity, maximum wear rate) for the device. Instead, the focus is on comparability to existing, cleared devices.

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

No test set was used for clinical evaluation. The document explicitly states "Clinical Testing: None provided." The evaluation of the device for substantial equivalence relied solely on non-clinical (mechanical) testing.

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

Not applicable, as no clinical testing with a test set involving human data was performed.

4. Adjudication Method for the Test Set

Not applicable, as no clinical testing with a test set involving human data was performed.

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 revision knee implant, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.

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 (expert consensus, pathology, outcomes data, etc.)

For the non-clinical mechanical testing, the "ground truth" or reference for evaluating substantial equivalence was the performance of predicate devices. The specific types of measurements (e.g., force, displacement, stress) during the mechanical tests served as the data points compared against the predicate devices.

8. The Sample Size for the Training Set

Not applicable. This device is a physical knee implant, not a machine learning algorithm that requires a training set.

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

Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "Exprt Revision Knee" device's acceptance was based on non-clinical mechanical testing demonstrating its substantial equivalence to legally marketed predicate devices.

• Study Design: The study involved a series of mechanical tests designed to evaluate the physical performance and characteristics of the Exprt Revision Knee.
• Tests Performed:
  • Static contact area/contact stress testing
  • Static testing in anterior-posterior draw
  • Static testing in rotary laxity
  • Patella subluxation evaluation
• Acceptance Criteria/Outcome: The device was deemed to have met the acceptance criteria because "All testing has determined that the device is substantially equivalent to the predicate devices." The specific quantitative metrics and thresholds for this equivalence are not detailed in the summary but were presumably part of the full 510(k) submission.
• Absence of Clinical Data: The submission explicitly states "Clinical Testing: None provided," indicating that FDA clearance was granted based solely on the non-clinical mechanical testing and comparison to existing predicate devices.

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