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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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