(20 days)
The Hoffmann® II Micro External Fixation System is intended to be used with the Half Pins or Transfixing Pins of the Hoffmann® External Fixation System and the Components of the Hoffmann® II External Fixation System. It is intended to be used in the stabilization of open and/or unstable fractures and where soft tissue may preclude the use of other fracture treatments such as IM rodding, casting and other means of internal fixation.
This Special 510(k) submission is intended to address a material modification and design modifications to the predicate Hoffmann® II Compact" External Fixation System. The subject device, named the Hoffmann® II Micro External Fixation System, is a line extension of the Hoffmann® II Compact External Fixation System. The predicate Hoffmann® II Compact External Fixation System is fabricated from stainless steel and aluminum. The subject Hoffmann® II Micro External Fixation System is fabricated from stainless steel. The Hoffmann® II Micro External Fixation System is a miniaturization of the Hoffmann® II Compact "External Fixation System. The miniaturization involves modifying the overall size of the components as well as reducing the size of the mating components (Apex® pins and connecting rods).
The subject Hoffmann® II Micro External Fixation System shares the same intended use, and basic design concepts as that of the currently available Hoffmann® II Compact™ External Fixation System. Mechanical testing demonstrated comparable mechanical properties to the predicate components.
The provided text describes a 510(k) submission for a medical device and its substantial equivalence to a predicate device. However, it does not contain the information requested in your bullet points regarding acceptance criteria and the study that proves the device meets them.
The document focuses on:
- Device Identification: Naming the device, its common name, and classification.
- Device Description: Explaining that the Hoffmann® II Micro External Fixation System is a line extension of the Hoffmann® II Compact™ External Fixation System, miniaturized, and fabricated from stainless steel (whereas the predicate used stainless steel and aluminum).
- Intended Use: Stating its purpose for stabilizing open and/or unstable fractures.
- Substantial Equivalence: Confirming that mechanical testing demonstrated comparable mechanical properties to the predicate components, leading to FDA clearance.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, efficacy studies, sample sizes, expert involvement, or ground truth details, as this information is not present in the provided text.
The document states: "Mechanical testing demonstrated comparable mechanical properties to the predicate components." This is the extent of the "study" mentioned, aimed at proving substantial equivalence rather than defining and meeting specific acceptance criteria for performance in a clinical or diagnostic context.
§ 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.