(135 days)
Indicated for open and closed long bone fracture fixation to include tensioned wire fixation of periarticular fractures, arthrodesis, limb lengthening, osteotomy, reconstruction, non-unions, pseudoarthrosis, correction of bony or soft tissue defects and deformities.
This submission covers DePuy Orthopaedics' external fixators and their performance in the MR environment. The ACE-Fischer system is classified as MR Unsafe.
The provided text is a 510(k) premarket notification for the ACE-Fischer® External Fixation System. It describes the device, its indications for use, and its substantial equivalence to predicate devices. However, the document does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria.
Instead, the submission focuses on demonstrating substantial equivalence to currently marketed versions of the device, stating:
- "The technological characteristics of the devices that are the subject of this submission remain unchanged from the predicate in design, material and performance."
- "Evaluation was done based on ASTM F2052 to determine MR compatibility." (This refers to a standard for assessing MRI compatibility, not a study to prove performance against specific clinical acceptance criteria).
- The system is classified as "MR Unsafe."
Therefore, I cannot fulfill the request to provide a table of acceptance criteria, reported device performance, sample sizes, expert qualifications, or details about a comparative effectiveness study, ground truth, or training sets, as such information is not present in the provided document. The document's purpose is to establish substantial equivalence for regulatory clearance, not to detail a clinical performance study against specific acceptance criteria.
§ 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.