(126 days)
The Intramedullary Fixation Device is indicated for the fixation of extra-articular fractures of the hand including the metacarpals and the proximal and middle phalanges, and the metatarsal bones of the foot.
Intramedullary Fixation Device
Based on the provided text, the document is an FDA 510(k) clearance letter for a medical device called the "A.M. Surgical Intramedullary Fixation Device." This letter does NOT contain information about acceptance criteria, study design, or performance metrics for an AI/ML device. It is a regulatory clearance for a physical medical device (an intramedullary fixation device) used for bone fixation.
Therefore, I cannot extract the requested information regarding acceptance criteria and performance data for an AI/ML device from this document. The questions you've asked (about sample sizes, experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, etc.) are pertinent to studies evaluating AI/ML models, not traditional hardware medical devices like the one described in this 510(k) letter.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.