(258 days)
The Conventus DRSTM is intended for the fixation of distal radius fractures.
The Conventus DRSTM is an intramedullary device intended to treat distal radius fractures. The DRS is comprised of an Expandable Scaffold, Fragment Screws, and a Proximal Plate. The device remains flexible during placement, but is made rigid at the completion of the surgical implant procedure. The implant is made from titanium alloy (Ti6Al4V) and Nitinol.
The provided text is a 510(k) summary for the Conventus DRS™ (Distal Radius System) device, which is a fracture fixation device. The document describes the device, its intended use, and its substantial equivalence to a previously cleared device. However, it does not contain information about acceptance criteria, device performance metrics, or any studies with AI involvement.
The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (K102689) based primarily on the device's design, materials (titanium alloy and Nitinol), and intended use for distal radius fractures. The only "testing" mentioned is for "MR Conditional" labeling, which assesses safety in a magnetic resonance environment, not clinical performance for fracture fixation.
Therefore, I cannot populate the table or answer the questions as the required information (acceptance criteria, performance data, details of a study proving criteria, sample sizes, ground truth establishment, AI involvement, etc.) is not present in the provided document.
The document is a regulatory submission for a traditional medical device (fracture fixation) and does not appear to involve any AI/ML components for diagnosis, prediction, or intervention that would require performance studies against specific acceptance criteria in the manner described in your request.
§ 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.