(71 days)
Synthes 4.0 Adjustable Clamp for Distal Radius Fixator -MR Safe is part of a construct intended for the stabilization of fractures of the distal radius.
Synthes Distal Radius Fixator consists of frame elements that form a construct intended to treat fractures of the distal radius. The Distal Radius Fixator provides stabilization of fractures via pins (Schanz screws) inserted proximally and distally to a fracture and connected by an external bridging frame consisting of two 4.0 mm Adjustable Clamps, a carbon fiber rod and two protective end caps. This device is intended for use in the MR environment. The Distal Radius Fixator is available as a complete sterile assembly or as individual, nonsterile components.
The provided text does not contain information about acceptance criteria or a study proving device performance as it pertains to AI/ML or diagnostic performance. Instead, it is a 510(k) summary for a medical device (Synthes 4.0 mm Adjustable Clamp for Distal Radius Fixator - MR Safe) and the FDA's clearance letter for it.
The document focuses on:
- Device Description and Intended Use: Stabilization of distal radius fractures.
- MR Safety: The key aspect highlighted, implying testing for compatibility with an MR environment.
- Substantial Equivalence: The primary basis for FDA clearance, comparing it to a legally marketed predicate device.
To answer your specific questions related to acceptance criteria, AI/ML performance, and ground truth, that information would typically be found in a study report for a diagnostic or AI-powered device, which is not present in this document.
§ 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.