(120 days)
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.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.