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The DePuy AMK and Coordinate Ultra Cross-Linked Polyethylene Inserts and Trays are to be used with the currently marketed AMK Total Knee System and/or the Coordinate Ultra Knee Revision System components.

The DePuy AMK Total Knee System and Coordinate Ultra Knee Revision System are intended to be used in cemented tricompartmental total knee arthroplasty to replace severely disabled or painful joints resulting from osteoarthritis or posttraumatic arthritis, joints with correctable varus or valgus deformity, and joints with failed previous surgeries where pain, deformity or dysfunction persist.

The subject DePuy AMK and Coordinate Ultra cross-linked polyethylene tibial inserts and trays are available in five sizes (1-5) with five thickness' (10, 12, 14, 16, and 18mm) or ten thickness' (10, 12, 14, 16. 18. 20. 22. 24. 26. and 28mm), depending on the specific device, in each size. The cross-linked polyethylene tibial inserts fasten to a metal tibial tray by means of a central pin and interlocking clip or a tibial stabilizing post. The fixative surface of the cross-linked polyethylene tibial trays have a salt-blasted surface, a round central stem, and cloverleaf patterned recesses to enhance cement fixation to the proximal tibia surface.

This is a 510(k) premarket notification for a medical device, specifically orthopaedic implants. These types of submissions typically focus on demonstrating substantial equivalence to a predicate device rather than presenting detailed studies with acceptance criteria, sample sizes, and ground truth definitions as would be found for AI/ML-based diagnostic devices.

Therefore, the information requested in your prompt (especially regarding acceptance criteria tables, sample sizes for test/training sets, expert consensus for ground truth, adjudication methods, and MRMC studies) is not applicable to this type of regulatory submission for a knee prosthesis and is not present in the provided text.

The closest analogy to "acceptance criteria" in this context are the limitations and conditions placed on the marketing of the device by the FDA:

1. Table of "Acceptance Criteria" and Reported Device Performance:

Since this is a substantial equivalence determination for a physical implant, specific performance metrics like sensitivity, specificity, or AUC suitable for a table directly presenting acceptance criteria and device performance as you might see for an AI/ML device are not provided. Instead, the "acceptance" from the FDA is granted based on substantial equivalence and comes with specific limitations.

Study Details:

• 2. Sample size used for the test set and the data provenance: Not applicable. This submission is for a physical device, not an AI/ML algorithm requiring a test set of data. Substantial equivalence is determined by comparing the new device's design, materials, and intended use to a legally marketed predicate device.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in the context of diagnostic AI/ML is not relevant here. The FDA's review is an assessment of technical and clinical equivalence by its own staff.
• 4. Adjudication method (e.g., 2+1, 3+1, none) 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. This is not an AI/ML device.
• 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML algorithm.
• 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.

Explanation of the Study and Substantial Equivalence:

The "study" in this context is the 510(k) premarket notification process itself. DePuy, Inc. submitted this notification to the FDA to demonstrate that their new DePuy AMK® Total Knee System and Coordinate Ultra™ Knee Revision System with cross-linked polyethylene tibial inserts and trays are substantially equivalent to legally marketed predicate devices.

The basis of this substantial equivalence is described as:

• Basic Same Design: The new components have the "basic same design" as previously cleared polyethylene tibial inserts and trays.
• Same Intended Use: The new components have the "same intended use" as the predicate devices: cemented tricompartmental total knee arthroplasty for severely disabled or painful joints.
• Materials: Both the new and predicate devices are manufactured from UHMWPE (Ultra High Molecular Weight PolyEthylene) meeting ASTM F648 specifications.
• Difference: The only significant difference is that the new components are manufactured from cross-linked UHMWPE, with "minor design changes" otherwise.

The FDA reviewed this comparison and made its determination based on these engineering and design equivalencies rather than clinical trial data demonstrating performance against specific clinical acceptance criteria for diagnostic accuracy, which is what your questions imply. The FDA's letter (Page 1) confirms that they "determined the devices are substantially equivalent... to devices marketed in interstate commerce prior to May 28, 1976..." subject to the specific limitations listed.

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