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APTUS® Ulna Plates are indicated for fractures and osteotomies, in particular for the ulna.

The APTUS Ulna Plates consists of titanium locking plates and locking and non-locking titanium screws. APTUS Ulna Plates are provided in four designs: Y (distal ulna), Olecranon Straight, Olecranon Right/Left and Olecranon Tension. The plates are used with TriLock locking screws, cortical screws or lag screws (all of which have cortical threads). APTUS Ulna Plates are made of commercially pure titanium, Grade 4, conforming to ASTM F67 and TriLock locking and cortical screws are made of titanium alloy conforming to ASTM F136.

The provided text describes a 510(k) premarket notification for the APTUS® Ulna Plates, which are orthopedic fixation devices. This type of submission focuses on demonstrating substantial equivalence to a predicate device already on the market, rather than conducting de novo clinical studies with specific acceptance criteria in the way a diagnostic AI device would.

Therefore, the requested information regarding acceptance criteria, study details (sample size, data provenance, ground truth, experts, adjudication, MRMC, standalone performance, training set), is not applicable to this 510(k) submission for APTUS® Ulna Plates.

Instead, the submission relies on performance data provided to demonstrate substantial equivalence, which included:

• Detailed dimensional analysis of the subject and predicate plate designs.
• Fatigue testing of the subject and predicate plate design constructs.

The "acceptance criteria" here are implicitly that the APTUS® Ulna Plates perform as safely and effectively as the predicate devices in these engineering tests, confirming similar mechanical properties suitable for their intended use. The study "proves" the device meets these (unspecified numerical) acceptance criteria by demonstrating that the mechanical performance is comparable to devices already deemed safe and effective by the FDA.

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