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The Skeletal Dynamics Midshaft Humerus Plating System is indicated for fixation of the humerus for use in fixation of peri-prosthetic fractures, osteopenic bone and fixation of non-unions or malunions in adult patients.

The Skeletal Dynamics Midshaft Humerus Plating System include Broad and Narrow Midshaft Humerus Plates and 4.5 mm Locking and Compression Screws made from medical grade titanium alloy. The bottom surface of the plates feature undercuts to facilitate bending, when necessary, to ensure the best fit for differing patient anatomy and oblong threaded slots for the screws. The locking screws feature a double lead locking thread on the head to mate with the plate's threaded slots.

This FDA 510(k) summary describes a medical device, the Skeletal Dynamics Midshaft Humerus Plating System, not an AI/ML powered device. Therefore, the information typically required for describing the acceptance criteria and study proving an AI/ML device meets them (such as details on sample size for test sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, ground truth establishment for training and test sets) is not applicable and not present in this document.

The provided document instead focuses on demonstrating substantial equivalence to a predicate device through:

1. Acceptance Criteria and Device Performance (based on mechanical testing):

• ASTM F382: Standard Specification and Test Methods for Metallic Bone Plates.
• ASTM F543: Standard Specification and Test Methods for Metallic Bone Screws.
  Engineering analysis was used to establish substantial equivalence of the subject screw to the secondary predicate with respect to pullout testing. |

2. Details not applicable for AI/ML devices:

• Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. The "test set" here refers to physical components subjected to mechanical testing, not a dataset of patient images or clinical data.
• 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. Ground truth for mechanical devices is established through engineering specifications and standardized test methods, not expert human assessment.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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 a medical implant, not an AI diagnostic or assistance tool.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert concensus, pathology, outcomes data, etc): For the mechanical device, the "ground truth" is defined by the performance parameters outlined in the ASTM standards (e.g., strength, stiffness, fatigue life) that the device must meet or demonstrate equivalence to the predicate.
• The sample size for the training set: Not applicable. There is no "training set" for this type of device.
• How the ground truth for the training set was established: Not applicable.

Summary of the Study:

The study conducted was a benchtop mechanical testing study designed to demonstrate the substantial equivalence of the Skeletal Dynamics Midshaft Humerus Plating System to its predicate device, the Synthes 4.5 mm Locking Compression Plate (LCP) System.

• Methods: The testing followed established ASTM standards: ASTM F382 for bone plates and ASTM F543 for bone screws. Additionally, engineering analysis was used for screw pullout testing equivalence to a secondary predicate (ARMAR™ / ARTIS™ Screws).
• Conclusion: The performance testing, comprising both mechanical testing and engineering analysis, demonstrated that the Skeletal Dynamics Midshaft Humerus Plating System is substantially equivalent to the predicate device in terms of safety and effectiveness. The minor differences in design did not negatively impact safety, effectiveness, or performance.

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