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The OlecraNail™ Intramedullary Fixation System and accessories are intended for the surgical fixation of all fractures and surgical osteotomies of the proximal ulna in the acute or chronic setting.

The OlecraNail™ intramedullary rod is a solid bore, stainless steel, tapered rod that is inserted into a pre-drilled hole into the medullary canal of the proximal ulna. Once the device is in place, a carbon fiber composite guide is used to drill into the bone and insert several screws through the bone and rod to secure all bone fragments and lock the rod into position. During this process, compression at the fracture site may be obtained by manually turning a knob to activate the compression mechanism. After all screws are placed, the guide may then be detached using a break-away mechanism.

The provided document is a 510(k) summary for the OlecraNail™ Intramedullary Fixation System. It describes the device, its intended use, and states that it is substantially equivalent to predicate devices. However, this document does not contain a study that proves the device meets specific acceptance criteria.

The FDA clearance is based on the device's substantial equivalence to already legally marketed devices, not on the results of a new performance study with predefined acceptance criteria. The statement, "A review of the test data for the subject devices indicates that they are equivalent to the predicate devices currently in clinical use and are capable of withstanding expected in vivo loading without failure," suggests that some engineering or bench testing was performed to demonstrate this equivalence, but the details of such testing, acceptance criteria, and specific performance results are not provided in this summary.

Therefore, I cannot populate the requested table and information points as they pertain to a performance study with acceptance criteria and reported device performance. The document explicitly states:

• "There are no changes in intended use, performance specifications or method of operation." This means the device relies on the established performance of its predicates.
• "Substantial equivalence for the OlecraNail™ Intramedullary Fixation System is based on their similarities in indications for use, design features, operational principles, and material composition when compared to the predicate devices..." This confirms the basis of clearance is similarity, not a new clinical performance study.

In summary, the provided text does not contain the information required to fulfill your request for an acceptance criteria table and study details. The FDA 510(k) clearance in this case is based on substantial equivalence through comparison to predicate devices, not on a new clinical or performance study with defined acceptance criteria for the device itself.

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