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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.

Device Description

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.

AI/ML Overview

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

Acceptance Criteria	Reported Device Performance
Mechanical Performance: Compatible with existing EXPRT Revision Knee system and demonstrably equivalent to predicate devices in function.	"Analyses were performed which included drawing review with tolerance stack ups and anatomic bone model evaluation."
"All evaluations have determined that the devices are substantially equivalent to the applicable predicate devices."
Material: Use of established biocompatible materials.	Ti alloy for femoral augment, CoCrMo alloy for stem extension. These are standard materials used in knee prostheses and are implicitly considered acceptable due to their use in predicate devices.
Biocompatibility/Safety (Endotoxin): Meet endotoxin limits for implanted devices.	"Bacterial endotoxin testing was conducted and was found to meet the expected endotoxin limits."
Sterilization: Compatible with established sterilization methods.	Implied to be consistent with the predicate device and standard for such implants, as "sterilization" is listed as a comparable feature to predicate devices.
Indications for Use: Indications should align with the predicate device, demonstrating similar clinical application.	The indications for use provided are standard for knee joint replacement due to conditions like arthritis, avascular necrosis, post-traumatic issues, and deformities, aligning with established uses for such devices.
Design: The device design (e.g., thickness, length, fixation method) should function as intended and be comparable or justified in differences to predicate designs.	Femoral augment: 5mm thick, 4 sizes, covers posterior or distal femoral resection, fits cement pocket.
Stem extension: 40mm long, straight, fluted, cemented application, for tibial base plate and femoral component.

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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