(48 days)
The Synthes (USA) Medium External Fixation System is intended for use in the construction of an external fixator frame for the treatment of pediatric and adult fractures.
Synthes Medium External Fixation System - MR Safe is a system of components that form a construct intended to treat stable and unstable fractures. Frame components designed for this system are the Medium Multi-Pin Clamps (four / six position) - MR Safe, the Medium Combination Clamp - MR Safe, the 8.0 mm/11.0 mm Combination Clamp - MR Safe and the Medium Open Adjustable Clamp - MR Safe. Also included in this MR Safe system are the Medium Dynamization Clip and Medium Rod Attachment, which are accessories to the Combination and Multi-Pin Clamps, respectively. These clamp accessories allow dynamization during bone healing and double stacking of the frame. The system accepts Synthes 8.0 mm carbon fiber rods (in lengths from 100 - 500 mm) and Schanz screws (in diameters of 4.0 - 5.0 mm). All frame elements are made from non-magnetic materials and are intended for use in the MR environment.
The provided document describes a 510(k) premarket notification for the "Synthes Medium External Fixation System - MR Safe." This device is a system of components that form a construct intended to treat stable and unstable fractures. The document is a regulatory submission to the FDA, asserting substantial equivalence to a predicate device.
Based on the information provided, it is not possible to describe acceptance criteria or a study proving the device meets those criteria, as detailed in your request. Medical device 510(k) submissions typically focus on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical studies with specific acceptance criteria, sample sizes, expert panels, or MRMC studies.
The document indicates that "Documentation is provided in this premarket notification that demonstrates that Synthes Medium External Fixation System -- MR Safe is substantially equivalent to other legally marketed devices." This implies that the 'study' conducted (though not explicitly detailed in these excerpts) would have been a comparison to the predicate device, focusing on similar technological characteristics and intended use, rather than a clinical trial with performance metrics against acceptance criteria.
Therefore, I cannot provide the requested information such as a table of acceptance criteria, sample sizes for test sets, number/qualifications of experts, adjudication methods, MRMC study results, standalone performance, types of ground truth, or training set details. These elements are typically associated with performance studies, which are generally beyond the scope of the information included in this 510(k) summary and FDA clearance letter.
The FDA's letter (K040258) confirms that they have reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. This determination allows the device to be marketed, subject to general controls provisions of the Act (e.g., registration, labeling, GMP). It does not imply a clinical study with detailed performance metrics as would be required for innovative devices or those requiring PMA.
§ 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.