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Stabilization of open and/or unstable fractures and where soft tissue injury may preclude the use of other fracture treatments such as IM Rodding, casting, and other means of internal fixation.

A carbon fiber rod has an aluminum cap threaded onto one end. That cap slides axially in another bar that is partially externally threaded. There is a slot that runs the length of the external thread that accepts a pin that is part of the aluminum cap. There are two circular nuts that tighten on the pin which allow the device to be used in either compression or distraction mode. The partially threaded rod is made of aluminum and the circular nuts of made of stainless steel.

The provided document is a 510(k) premarket notification for a medical device, the "Radiolucent Colles Compression/Distraction Bar." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than independently proving safety and effectiveness through extensive clinical trials with specific acceptance criteria and performance metrics.

Therefore, the document does not contain the information requested regarding:

• A table of acceptance criteria and the reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm only) performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

Instead, the document states:

• Clinical Testing: None provided as a basis for substantial equivalence.
• Non-Clinical Testing: The following tests were used to determine substantial equivalence: Cantilever Testing, Torsional Testing, and Sawbone Lab Testing. (No specific acceptance criteria or performance results from these tests are provided, only that they were used to establish equivalence).

The basis for market clearance for this device is its "substantial equivalence" to a predicate device (Biomet® Radiolucent Colles Fracture Kit, K001760), implying that its performance and safety are considered equivalent if its technological characteristics (materials, design, sizing, and indications) are similar or identical.

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