(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.
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ALG 23 1000
Image /page/0/Picture/2 description: The image shows the logo for Orthopaedic Biosystems LTD., Inc. The logo consists of the letters OBL stacked on top of each other. The letters are in a bold, sans-serif font and are black in color. The text "ORTHOPAEDIC BIOSYSTEMS LTD., INC." is written below the logo.
Small Bone Screw 510(k)Summary Safety and Effectiveness
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.
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