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The Synthes 3.5 mm LCP Distal Humerus System is indicated for intraarticular fractures of the distal humerus, comminuted supracondylar fractures, osteotomies, and non-unions of the distal humerus.

The Synthes 3.5 mm LCP Distal Humerus System consists of medial and postero-lateral distal humerus plates of various lengths and 2.7 mm locking screws. The plates are pre-contoured to match the anatomy of the distal humerus with a limited contact low profile design. The plate features locking compression holes and conical locking holes which accept 2.4, 3.5, & 4.0 mm cortex screws, 2.4, 2.7 & 3.5 mm locking screws, and 4.0 mm cancellous screws. The System will be available in Stainless Steel and Titanium.

The provided text does not contain information about acceptance criteria or a study proving the device meets said criteria.

The document is a 510(k) summary for a medical device (Synthes 3.5 mm LCP Distal Humerus System) and an FDA clearance letter. It describes the device, its intended use, classification, and predicate devices, and concludes that it is substantially equivalent to legally marketed predicate devices.

However, it does not include:

1. A table of acceptance criteria and reported device performance.
2. Details on sample size, data provenance, number or qualifications of experts, or adjudication methods for a test set.
3. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
4. Data on standalone algorithm performance.
5. The type of ground truth used for any study.
6. The sample size for a training set or how its ground truth was established.

Therefore, I cannot populate the requested table or answer the specific questions related to acceptance criteria and study details.

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