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The Apex All Poly Tibia is intended for use as part of a primary or revision total knee replacement. This prosthesis may be used for the following conditions, as appropriate:

• Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
• Rheumatoid arthritis;
• Correction of functional deformity;
• Revision procedures where other treatments or devices have failed.

The Apex All Poly Tibia is for use only with the Apex Knee™ System Femoral and Patella components. The Apex All Poly Tibia is indicated for cemented use only.

The Apex All Poly Tibia is used as part of a primary or revision cemented total knee implant using established total knee arthroplasty procedures. The All Poly Tibia is intended for use with bone cement, single use implantation and for use only with the Apex Knee™ System Femoral and Patella components.

The device is machined from compression molded Ultra High Molecular Weight Polyethylene (UHMWPE per ASTM F648). This device is a semi-constrained monoblock tibia and designed for posterior cruciate substitution.

The provided text describes a 510(k) premarket notification for the "Apex All Poly Tibia" device, which is part of the "Apex Knee™ System." The submission aims to demonstrate substantial equivalence to legally marketed predicate devices. The information focuses on non-clinical testing for the device.

Here's an analysis based on the provided text, addressing your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states "All samples tested met the acceptance criteria." however, it does not specify the sample sizes used for any of the non-clinical tests (FEA Contact Stress Testing, Peg Stiffness Analysis, Cement Mantle Stress Analysis, FEA Abrasive Wear, or Insert Contact Pressure and Contact Area Testing).

The data provenance is not explicitly stated beyond being non-clinical tests typically conducted in a lab environment. There is no mention of country of origin of the data, or if it's retrospective or prospective.

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

Since these are non-clinical engineering tests (FEA, stiffness, wear, contact pressure), the concept of "ground truth" established by human experts in the typical clinical sense (like radiologists reading images) does not apply. The "ground truth" for such tests would be based on established engineering principles, material properties, and test standards (e.g., ASTM F2083-08). The document does not mention any human experts establishing ground truth for these specific non-clinical tests.

4. Adjudication Method for the Test Set

Not applicable. As these are non-clinical engineering tests with objective measurements against defined acceptance criteria (implicitly derived from engineering standards or predicate device performance), there is no mention of an adjudication method involving human interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical studies were performed."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable to this submission. The device is a physical knee implant, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" is based on:

• Engineering principles and simulations: For FEA Contact Stress, Peg Stiffness, Cement Mantle Stress, and FEA Abrasive Wear.
• Standardized test methods: Specifically, ASTM F2083-08 for Insert Contact Pressure and Contact Area Testing.
• Comparison to predicate device specifications/performance: While not explicitly detailed as "ground truth," the overall goal of the 510(k) is to demonstrate substantial equivalence to predicate devices, implying that the performance of the new device should be within acceptable limits relative to the predicates.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device, not an AI or machine learning model. Therefore, 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 a physical medical device.

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