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The small Duracon® Stabilizer Tibial Insert is intended to be used with Howmedica Universal tibial baseplates in cemented primary or revision total knee arthroplasty. This insert is intended to be used specifically when the cruciate ligaments are inadequate, not present, or cannot be preserved during the operative procedure, especially when anterior-posterior stability is impaired due to absence of the patella. The intercondylar post of the insert is intended to limit anterior-posterior motion, as does the posterior cruciate ligament in the intact knee.

This design is not intended to provide an absolute substitution for either collateral ligament. Therefore, the collateral ligaments should be intact, or there should be adequate overall capsular ligamentous stability.

This 510(k) describes a modification to the design of the locking screw of the small Duracon Stabilizer insert. The screw length was optimized to increase the engagement into the baseplate. Fatigue testing was presented to support this design optimization. This design change is being undertaken to address laboratory breakage of the small Duracon stabilizer locking screw under severe loading conditions.

There is no modification in the intended use of the product. The small Duracon Stabilizer Tibial Insert is intended to be used with Howmedica Universal tibial baseplates in cemented primary or revision total knee arthroplasty. This insert is intended to be used specifically when the cruciate ligaments are inadequate, not present, or cannot be preserved during the operative procedure, especially when anterior-posterior stability is impaired due to absence of the patella. The intercondylar post of the insert is intended to limit anterior-posterior motion, as does the posterior cruciate ligament in the intact knee.

This design is not intended to provide an absolute substitution for either collateral ligament. Therefore, the collateral ligaments should be intact, or there should be adequate overall capsular ligamentous stability. As previously stated, this product is intended to be used as part of a cemented total knee system.

The design of the small tibial insert and Vitallium support bracket are unchanged. The only design modification is that the locking screw has been lengthened.

There has been no change in the materials used in the fabrication of the inserts and screws. The tibial insert is fabricated from Ultra-high Molecular Weight Polyethylene which conforms to ASTM specification F-648. The support bracket is manufactured from cast cobalt-chromium-molybdenum (Vitallium®) allov which conforms to ASTM specification F-75. The locking screw is manufactured from wrought Vitallium alloy which conforms to ASTM F-799.

The provided text describes a 510(k) summary for a design modification to a medical device, specifically the Small Duracon Stabilizer Insert and Screw. This type of submission is for changes to an existing device and does not typically involve the extensive clinical trials or human-in-the-loop performance studies that would be associated with a novel AI/software medical device.

Therefore, many of the requested categories in your prompt are not applicable to this specific document as it pertains to a mechanical design change and not an AI/software device.

Here's the information that can be extracted and a clear indication of what is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Sample Size (for initial fatigue testing): Six small Duracon stabilizer tibial inserts.
• Sample Size (for multi-axis dynamic testing): "Fewer samples were tested" (specific number not provided, but less than six).
• Data Provenance: Laboratory testing. No country of origin is specified, but it's implied to be within the manufacturer's testing facilities (Howmedica). This is retrospective as it's a verification of a new design before market release.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. The "ground truth" for this device is mechanical integrity and performance under specific loading conditions, which is established through engineering principles and laboratory testing, not expert medical opinion on diagnostic or prognostic outcomes.

4. Adjudication method for the test set:

• Not Applicable. Mechanical testing does not involve adjudication. The results are binary (pass/fail based on survival) and quantitative (number of cycles).

5. If a multi reader multi case (MRMC) comparative effectiveness study was done:

• Not Applicable. This is a design modification to a mechanical implant, not a diagnostic or prognostic device that would involve human readers or AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not Applicable. There is no algorithm involved in this device.

7. The type of ground truth used:

• Mechanical Performance Data: The ground truth is the physical survival of the components under specified dynamic loading conditions, measured in cycles without failure.

8. The sample size for the training set:

• Not Applicable. This is a mechanical 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, this is not relevant.

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