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The wires are intended for use in the fixation of bone fractures, for bone reconstruction, or as a guide/aid for the insertion of other medical devices.

The device consist of various diameter and length wires for use in the fixation of bone fractures, bone reconstruction, or as a quide or aide for insertion of other medical devices. The wires are made of 316LVM Stainless Steel.

This document is a 510(k) summary for a Bone Fixation Wire (Kirschner Wire) and does not contain information about acceptance criteria or a study proving device performance against such criteria. The document establishes substantial equivalence to a predicate device, and thus does not include a performance study with acceptance criteria in the context of AI/ML device evaluation.

Therefore, I cannot provide the requested information.

Here's why the input document doesn't contain the requested information:

• Device Type: The device described is a physical medical device (bone fixation wire), not a software or AI/ML device.
• Regulatory Pathway: The document is a 510(k) summary, which focuses on demonstrating "substantial equivalence" to a predicate device already on the market, rather than proving novel performance against specific acceptance criteria through a clinical or algorithmic performance study.
• Date: The document is from 2008, predating the widespread use of sophisticated AI/ML in medical devices and the specific regulatory guidance around their evaluation.

To answer your questions about acceptance criteria and studies, the source document would need to be a regulatory submission (e.g., PMA, De Novo, or a 510(k) for an AI/ML device) that includes a performance study section.

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