(77 days)
The Syntec Tibial Nail System is intended to stabilize fractures of the proximal and the tibial shaft; certain pre-and post-isthmic fractures; open and closed tibial shaft fractures; and tibial malunions and non-unions
The Syntec Tibial Nail System are manufactured from commercially SUS316L (stainless steel) and Ti-6AL-4V (Titanium alloy). It is an intramedullary (IM) nail with a 12° in the upper third of the reamed Tibial Nail. These nails will use ø5mm internal hex captured screws in various lengths for cross-screw fixation in both the proximal and distal portion of the nail. Also, an End Cap ø8.4 in 15mm lengths is available for proximal closing of the nail. The Syntec Tibial Nail System (nail, screw and end cap) are provided non-sterile and single use only. Also, it is not for spinal use. Associated instrumentation such as aiming device for proximal and distal, insertion guide wire, drill accessories, system and removal instruments are available with the system.
I am sorry, but the provided text does not contain the information required to answer your request. The document describes a medical device, the Syntec Tibial Nail System, and its clearance as substantially equivalent to predicate devices by the FDA. However, it does not include details about acceptance criteria, device performance metrics, sample sizes for testing, expert qualifications, ground truth establishment, or clinical study results with effect sizes against human readers. The document explicitly states that "Clinical studies are not required to support substantially equivalent" and only mentions "Biomechanical Test: The biomechanical tests ASTM F1264-16e1 were performed to determine substantial equivalence for the Syntec Tibial Nail System".
Therefore, I cannot provide a table of acceptance criteria and reported device performance or information regarding multi-reader multi-case studies, standalone performance, or sample sizes/ground truth details for training and test sets.
§ 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.