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intended for use in internal fixation of small bones including the craniomaxillofacial skeleton secondary to trauma or for reconstruction.

This submission describes a system of small bone screws. Screws are available in diameters ranging from 0.8 to 2.4 mm and lengths ranging from 2 mm to 28 mm. These devices are for single use only.

This looks like a 510(k) summary for a medical device (bone screws), not a study evaluating an AI algorithm. Therefore, the questions about acceptance criteria for an AI device and an AI study are not applicable to the provided text.

The document describes:

• The device proprietary name: Leibinger® - Luhr® Small Craniomaxillofacial Bone Screw System
• Its intended use: internal fixation of small bones including the craniomaxillofacial skeleton secondary to trauma or for reconstruction.
• Device characteristics: Screws in diameters ranging from 0.8 to 2.4 mm and lengths from 2 mm to 28 mm, for single use.
• Predicate devices: The submission establishes equivalence based on similarities in intended use, material, design, and operational principle to several existing bone screw systems (Howmedica Luhr® Fixation System, Wurzburg® Bone Screws, Steinhauser® Bone Screws, and Howmedica Leibinger Forefoot Reconstruction System).

To address your specific questions, this type of document typically relies on substantial equivalence to predicate devices rather than a performance study with acceptance criteria in the way an AI algorithm would be evaluated. For devices like bone screws, performance is generally established through:

• Material properties testing: Tensile strength, fatigue life, corrosion resistance, biocompatibility.
• Mechanical testing: Torsion, bending, pull-out strength, insertion torque, shear strength, and other appropriate biomechanical tests to ensure the screws can withstand expected physiological loads.
• Sterility validation: To ensure the device is sterile for use.
• Biocompatibility testing: To ensure the materials are non-toxic and do not cause adverse tissue reactions.

However, none of these specific tests or their acceptance criteria are detailed in this 510(k) summary; instead, the summary states that equivalence is based on similarities to previously cleared devices. If a study was performed, it would typically be a set of mechanical and material tests comparing the new device to the predicate devices, demonstrating that the new device performs equivalently or better within an acceptable margin.

Therefore, I cannot populate the table or answer the other questions as they pertain to an AI study.

Ask a specific question about this device