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The Synthes (USA) Sternal Fixation System is intended for use in primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion.

The Synthes (USA) Sternal Fixation System consists of machined titanium plates, a quick-release pin and 3.0 mm locking screws. The plates utilize screw fixation to create the construct.

I am sorry, but based on the provided document, there is no information about acceptance criteria, device performance, a study, sample sizes, experts, adjudication methods, multi-reader multi-case studies, standalone performance studies, or ground truth.

The document is a 510(k) summary and an FDA clearance letter for the Synthes (USA) Sternal Fixation System, a medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than providing the detailed study design and results typically found in a clinical trial report.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study proving device performance.

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The Synthes Sternal Fixation System is intended for use in primary or secondary closure/repair of the sternum following sternotomy or fracture of the stemum to stabilize the sternum and promote fusion.

The Synthes Titanium Locking Plates feature compression screw holes which accept existing 2.4 and 3.0mm locking screws, have notched sides and undersides. The plates are available in lengths of 96 and 160mm with 12 and 20 holes.

This 510(k) summary (K052683) is for a medical device (Synthes Sternal Fixation System), not an AI/ML powered device. As such, the concepts of acceptance criteria for algorithm performance, sample size for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable.

This submission focuses on demonstrating substantial equivalence to a predicate device based on its intended use, design, and materials, primarily through descriptive information rather than performance studies that would involve "device performance" in the context of an AI algorithm.

Therefore, I cannot provide the requested information in the format of acceptance criteria and a study that proves the device meets those criteria, as it is outside the scope of this type of medical device submission.

Ask a specific question about this device