(258 days)
Trauson Intramedullary Nail is intended to be implanted into the intramedullary canal of femur or humerus for alignment, stabilization, fixation of fractures caused by trauma or disease.
The Trauson Intramedullary Nail made of medic 11 grade 3 16L stainless steel that meet ASTM F138 - 08 Standard Specification for Wrought 18Chromium-14 Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants. It is intended to be implanted into the intramedullary canal of femur or humerus for alignment, stabilization, fixation of fractures caused by trauma or disease. The subject devices are not provided sterile. No new materials are used in the development of this device.
The provided document is a 510(k) summary for a medical device called "Trauson Intramedullary Nail". This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study data for acceptance criteria.
Therefore, the document does not contain the information requested regarding acceptance criteria, a study proving the device meets those criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or detailed descriptions of ground truth establishment for a diagnostic AI device.
This submission is for a medical implant, an intramedullary nail, and relies on bench testing of material properties and comparison to existing legally marketed devices to establish safety and effectiveness. It is not a diagnostic AI device requiring the kind of performance metrics and study design outlined in the request.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.