(54 days)
The Acumed Supracondylar Nail is an intramedullary rod which addresses supracondylar fractures.
The Acumed Supracondylar Nail is an intramedullary rod which addresses supracondylar fractures. The nail is available in six different sizes with diameters of 11 mm, 12 mm, and 13 mm and lengths of 150 mm and 220 mm. The nail is used in conjunction with 5 mm interlocking screws. The Acumed Supracondylar Nail is manufactured from titanium per ASTM F 136. This device is provided pre-sterile. Sterility is achieved by gamma radiation. Validation of sterility is maintained on site. Sterility level is 106. Information regarding implantation, packaging, and labeling have been provided.
Based on the provided text, there is no information about acceptance criteria, device performance, or any studies conducted on the Acumed Supracondylar Nail.
The document is a 510(k) summary for a medical device (Acumed Supracondylar Nail) and focuses on describing the device, its materials, sterilization, and its substantial equivalence to a predicate device (Smith & Nephew Richards' Intramedullary Supracondylar Nail System) for regulatory approval purposes.
Therefore, I cannot provide the requested information in the format of the table or answer the specific questions about studies, sample sizes, ground truth, or expert involvement, as this data is not present in the provided text.
§ 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.