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The Internal Joint Stabilizer- Elbow is intended to provide temporary stabilization of the elbow joint after trauma or chronic elbow dislocation.

The Skeletal Dynamic's Internal Joint Stabilizer Elbow System (K153208) consists of a titanium base plate, with a Distal Connecting Rod and Proximal Connecting Rod, held together by adjustable locking joints and locking screws which allow for multiple degrees of freedom. The system is being modified to include an Internal Joint Stabilizer - Elbow titanium base plate applied to the Company's cleared Proximal Ulna Plates of the Distal Elbow Plating System (K171590), instead of directly to the ulna as does the base plate of the cleared Internal Joint Stabilizer Elbow System.

The subject Internal Joint Stabilizer- Elbow is attached to the cleared Proximal Ulna Plates by means of two #4-40 cobalt chrome screws of 5.5mm in length and the Proximal Connecting Rod is secured to the distal humerus at the axis of rotation using the cleared cobalt chrome axis pin provided in multiple lengths from 30mm to 70mm in 5mm increments. The modified system provides internal stabilization to the elbow joint in the same manner, function, and technology as the Company's cleared Internal Joint Stabilizer Elbow. The system includes specialized instrumentation.

When attached to the cleared Skeletal Dynamics proximal ulna plate, the Internal Joint Stabilizer Elbow sits on the same anatomical location over the ulna and under the musculature and soft tissue, as does the cleared Internal Joint Stabilizer - Elbow.

The system is provided non-sterile and is sterilized in the user facility.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "Internal Joint Stabilizer - Elbow." It describes the device, its intended use, and the basis for its substantial equivalence to a predicate device.

However, this document does not contain information on acceptance criteria for a study demonstrating device performance of a new or modified device against specific performance metrics for clinical or AI-based devices. Instead, it focuses on demonstrating substantial equivalence through mechanical testing and engineering analysis compared to a predicate device.

Therefore, I cannot provide a table of acceptance criteria and reported device performance related to clinical outcomes, nor can I describe study details like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, or training set details. This type of information is typically associated with studies demonstrating clinical efficacy or the performance of AI/ML-based diagnostic devices, which is not the subject of this 510(k) notification.

The document states:

• Performance Testing: "Engineering analysis and mechanical testing demonstrated that the Skeletal Dynamic's Internal Joint Stabilizer Elbow is equivalent to its predicate device currently marketed. Mechanical testing which established equivalency included static and fatigue testing of the construct applied to Skeletal Dynamic's cleared Proximal Ulna Plate."
• Conclusions: "The Skeletal Dynamic's Internal Joint Stabilizer - Elbow is substantially equivalent to the Internal Joint Stabilizer Elbow predicate device identified in this premarket notification."

The "study" in this context refers to the mechanical and engineering tests to show the modified device performs similarly to the predicate device in terms of structural integrity and function, not clinical or diagnostic accuracy. There is no mention of an algorithm or AI component in this device.

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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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