(181 days)
The EnHatch Orthopaedics Patient Optimized Humeral Fracture System is indicated for fractures, fracture dislocations, osteotomies, and non-unions of the proximal Humerus, particularly in osteopenic bone.
The EnHatch Orthopaedics Patient Optimized Humeral Fracture System is a system of pre-contoured fracture plates, screws, and instrumentation for the repair of fractures of the proximal Humerus. The plates are designed to fit the natural anatomy of the proximal Humerus and include 3 sizes, different components for left and right Humeri, and plates designed to fit in different positions on the humerus. The proximal portions of the plates accept 3.5 mm locking screws for fixation of head, tuberosity, and shaft fragments to the plate. The distal portions of the plates accept 3.5 mm cortex compression screws which hold the plate construct to the humeral shaft.
EnHatch Orthopaedics Patient Optimized Humeral Fracture System Plates and Screws will be sold non-sterile. They are packaged and shipped in comprehensive trays that allow for secure transportation and on site sterilization. Products used for replenishment will be shipped, non-sterile, in a protective package (poly bag or tube).
The provided document describes a medical device, the EnHatch Orthopaedics Patient Optimized Humeral Fracture System, and its 510(k) submission for substantial equivalence to legally marketed predicate devices. However, the document does not contain information about acceptance criteria and a study proving the device meets those criteria, particularly in the context of an AI/ML-driven device or a device requiring clinical performance evaluation.
Instead, this submission is for a traditional orthopedic implant (plates and screws) where substantial equivalence is primarily demonstrated through mechanical testing and comparison of technological characteristics to predicate devices.
Therefore, I cannot populate the requested table and answer the questions related to AI/ML device performance evaluation. The document explicitly states:
"Non-clinical mechanical testing was not necessary to determine substantial equivalence between the EnHatch Orthopaedics Patient Optimized Humeral Fracture System and the cited predicate devices.
- For the plates, Finite Element Analysis was used to compare the strength of each EnHatch Plate with a Synthes LCP plate.
- For the screws, a qualitative comparison to the Synthes predicate was done."
This indicates that the primary method of demonstrating equivalence was through mechanical engineering analysis (Finite Element Analysis) and qualitative comparison, not through clinical studies with acceptance criteria regarding sensitivity, specificity, or human-in-the-loop performance.
Therefore, the answer to your request is that the provided text does not contain the information necessary to fulfill the prompt as structured for an AI/ML device or a device requiring a clinical performance study with 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.