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The EPIC Extremity Snap-Off Screw is indicated for use in fixation of bone fractures or bone reconstruction.

Examples include:

*Fixation of small bone fragments

• Weil osteotomy

*Mono-cortical fixation

*Osteotomies and fracture fixation in the foot and hand

The Snap-Off Screw is intended for single use only.

The EPIC Extremity Snap-Off Screw will consist of headed snap off screws of various lengths and instruments to assist in implanting the devices.

The provided text is related to a 510(k) premarket notification for a medical device (EPIC Extremity Snap-Off Screw). It is a regulatory document from the FDA detailing the approval of a medical device based on its substantial equivalence to previously marketed predicate devices.

However, the document DOES NOT contain information regarding a study that proves the device meets specific acceptance criteria in the context of an AI/ML-driven medical device, nor does it provide details on human reader studies, ground truth establishment, or sample sizes related to AI model validation.

The document states:

• "No clinical testing was required."
• The non-clinical performance data summary explicitly lists tests related to the mechanical properties of a screw (e.g., ASTM F-543, Torsional Properties, Axial PullOut, Torque to Fail: Snap-Off Feature). These are physical engineering tests for a hardware device, not performance metrics for an AI/ML system.

Therefore, I cannot fulfill the request as the provided text doesn't contain the necessary information about an AI/ML device study. The questions are specifically framed for the validation of an AI/ML-driven device, which is not what this document describes.

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