(142 days)
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.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.