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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 combination stainless steel/polyphenylsulfone 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 text describes a medical device called the OlecraNail™ Intramedullary Fixation System. It focuses on demonstrating the device's substantial equivalence to previously marketed devices and its mechanical performance.

However, the provided text DOES NOT contain information regarding:

• Acceptance criteria in a quantitative sense (e.g., target accuracy, sensitivity, or specificity values).
• Any studies involving patient data, human readers, or clinical outcomes.
• Ground truth establishment for any clinical data.
• Sample sizes for test or training sets related to clinical performance.
• Details about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.

The "Non-Clinical Tests" section describes mechanical tests performed on the device:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Test set sample size: Not specified. The tests were performed on "Olecranail™ intramedullary rods" and "the rod-guide junction." The exact number of units tested is not stated.
• Data provenance: Not applicable. These were non-clinical, mechanical integrity tests performed on the device itself, not on patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. These were mechanical tests, not assessments requiring expert interpretation of clinical data.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable. This is not a clinical study requiring adjudication.

5. 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:

• No. The document describes mechanical tests of a physical orthopedic implant, not an AI-powered diagnostic or assistive device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• No. This device is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For the mechanical tests, the "ground truth" would be the measured physical properties (elastic limits, rigidity, torsional strength, stress tolerance) as compared against established engineering standards and performance of predicate devices.

8. The sample size for the training set:

• Not applicable. There is no "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established:

• Not applicable. There is no "training set" or corresponding ground truth.

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