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• Distal intra-articular tibia fractures
• Proximal tibia fractures
• Proximal and distal humerus fractures

The DePuy ACE TiMAX™ Meta Plate has a triangular shaped projection at the end of a shaft portion. The shaft portion has compression slots with a pitch of 13mm which matches the small fragment, active compression plate. The plate thickness is 1.6mm in the shaft region and transitions to a thickness of 1mm in the triangular shaped metaphyseal region. A cut-out in the middle of the metaphyseal region provides an open architecture to facilitate contouring by the surgeon, to accommodate the anatomical topography of the distal tibia as well as other indicated anatomical regions, and also to promote fracture healing. The screw holes have been designed to allow low profile interaction with the heads of the 3.5mm cortical screw and the 4.0mm cancellous screw. The plate will be offered in two sizes: small (width=30mm) and large (width=38mm) with various lengths.

This document is a 510(k) summary for a medical device (DePuy ACE TiMAX™ Meta Plate), which focuses on establishing substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria in the manner an AI/software device would. Therefore, most of the requested information regarding acceptance criteria and performance studies is not applicable to this type of submission.

Here's a breakdown of what can be extracted and what cannot:

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

• Not Applicable. This document is for a traditional medical implant (bone plate), not a software or AI device. The "performance" assessment focuses on the physical and mechanical equivalence to an existing device, not on specific quantitative metrics or a study demonstrating achievement of pre-defined acceptance criteria in the context of an AI/software product. The acceptance criteria for this type of device generally relate to safety, material biocompatibility, mechanical strength (often through bench testing), and similarity in design and intended use to a predicate device. These are assessed through a broader regulatory review, not a single "performance study" as would be done for an AI algorithm.

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

• Not Applicable. There is no "test set" or "data provenance" in the context of an AI/software device for this submission. The "testing" for this bone plate would typically involve bench testing (mechanical and material properties) and potentially cadaver studies, but not a dataset in the way an AI algorithm uses it. The document does not provide details on sample sizes for these types of tests, if they were conducted.

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" establishment in the context of an AI/software algorithm is described. For a bone plate, medical experts (e.g., orthopedic surgeons) would be involved in defining the intended use and potentially evaluating design, but not in establishing a "ground truth" for a dataset.

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

• Not Applicable. No "adjudication method" for a test set is described.

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 a study about 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 discussed.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

• Not Applicable. No "ground truth" in the context of an AI/software algorithm is described. The "ground truth" for a bone plate would be based on established medical and engineering principles, material science, and clinical experience with equivalent devices.

8. The sample size for the training set:

• Not Applicable. There is no "training set."

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

• Not Applicable. There is no "training set" or ground truth establishment in this context.

Summary of what the document does provide in relation to regulatory acceptance:

• Predicate Device: The DePuy ACE TiMAX™ Meta Plate is deemed substantially equivalent to the Synthes Cloverleaf Plate (P/N 240.23), which was a pre-amendment device (marketed prior to May 28, 1976). This substantial equivalence is the primary "acceptance criterion" for 510(k) submissions.
• Intended Use: The device is intended for distal intra-articular tibia fractures, proximal tibia fractures, and proximal and distal humerus fractures. This must align with the predicate device's intended use or be demonstrably safe and effective for similar uses.
• Device Description: The document describes the plate's physical characteristics (triangular shaped projection, shaft with compression slots, plate thickness, cut-out for contouring, screw hole design compatible with 3.5mm cortical and 4.0mm cancellous screws, two sizes). These features are compared to the predicate device to establish equivalence.
• Regulatory Decision: The FDA determined the device is "substantially equivalent" to predicate devices, allowing it to be marketed. This decision is the formal acceptance of the device for market.

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