(37 days)
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The proposed device, the small bone screw claims substantial equivalence to a currently marketed device, the Synthes mini-fragment bone screw. The Synthes screws and the proposed device are both available in Titanium and Stainless Steel. Both function as internal fixation for bones and have no significant design differences.
The provided text does not contain information about an AI/ML powered device, its acceptance criteria, or a study proving its performance. Instead, it describes a 510(k) summary for a small bone screw claiming substantial equivalence to a predicate device.
Therefore, I cannot answer your request regarding acceptance criteria and a study for an AI/ML device, as the provided input is irrelevant to that topic.
The input describes a medical device, a small bone screw, and its claim of substantial equivalence to a predicate device (Synthes mini-fragment bone screw) based on material (Titanium and Stainless Steel) and function (internal fixation for bones) with no significant design differences. This is a common process for regulatory clearance of traditional medical devices, not AI/ML driven ones.
§ 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.