(322 days)
EBA One Nailing System standard trochanteric nail is indicated for the treatment of stable intertrochanteric fractures, pertrochanteric fractures, non-unions, mal-unions.
EBA One Nailing System long trochanteric nail is indicated for the treatment of pertrochanteric fractures with extension of the fracture line to the diaphysis,pertrochanteric fractures associated with diaphyseal fractures (bifocal fractures), pathological fractures, non-unions, mal-unions.
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This document is an FDA 510(k) clearance letter for the EBA One Nailing System. It is not a study report for an AI/ML medical device. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, device performance, sample sizes, expert ground truth establishment, or comparative effectiveness studies for an AI/ML device.
The information you are asking for typically comes from a clinical validation study or performance testing report, which would be part of a 510(k) submission for an AI/ML device, but isn't explicitly detailed in the FDA clearance letter itself unless specifically summarized.
This letter solely confirms that the EBA One Nailing System (an intramedullary fixation rod, a physical implant, not an AI/ML software) has been deemed substantially equivalent to legally marketed predicate devices.
§ 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.