(87 days)
The EPIC Extremity Fracture Plate System is indication of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. The system can be used in both adult and pediatric patients. The plates/screws are intended for single use only.
The EPIC Extremity Fracture Plate System consists of multiple plate families of various anatomical sizes and shapes, 4.0mm locking and non-locking screws that mate into the plates, 4.0mm fully and partial threaded cancellous bone screws as well as various instruments to assist in implanting the system.
The EPIC Extremity Fracture Plate System is also designed to accept the 2.7mm/3.5mm locking/non-locking screws and various instruments to assist in implanting the system from the previously cleared EPIC Extremity Plate System (K153340).
Based on the provided text, the document is a 510(k) premarket notification for the "EPIC Extremity Fracture Plate System." This submission is for a medical device (bone fixation plates and screws), not an AI/Software as a Medical Device (SaMD). Therefore, the acceptance criteria and study design elements typically associated with AI/SaMD (such as performance metrics like sensitivity/specificity, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance) are not applicable to this submission.
The document explicitly states:
- "No clinical testing was required." This means there was no human clinical study conducted for this device.
- The non-clinical performance data summarized refers to "ASTM F-543," which is a standard specification for metallic medical bone screws. This concerns the mechanical properties and performance of the physical screws, not an AI algorithm's diagnostic or predictive capabilities.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves an AI device meets those criteria using the provided text. The provided document concerns a physical orthopedic implant, not a software-based medical device that would involve AI performance metrics.
In summary, none of the requested information regarding AI/SaMD acceptance criteria and study details can be extracted from this document, as it is irrelevant to the type of device being discussed.
§ 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.