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The Synthes 3.5 mm Broad LC-DCP Plates are intended for use on the diaphysis of the long bones (i.e., humerus, ulna, and tibia).

The Synthes 3.5 mm Broad LC-DCP Plate is of a Limited Contact - Dynamic Compression Plate (LC-DCP) design. The plates are 4.2 mm thick, 13.5 mm wide, and available in lengths from 90 mm (7 holes) to 285 mm (22 holes).

The provided document, K020872, is a 510(k) premarket notification for the "Synthes 3.5 mm Broad LC-DCP Plates," which are bone fixation plates. The FDA's review in this document focuses on establishing substantial equivalence to a legally marketed predicate device, rather than requiring performance studies with acceptance criteria to demonstrate safety and effectiveness for a novel medical device.

Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria and a study proving the device meets those criteria. Specifically, the following information is not present:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
6. Information about a standalone (algorithm only) performance study.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

The document primarily focuses on regulatory approval based on substantial equivalence and does not detail the technical performance testing typically associated with the type of acceptance criteria mentioned in the prompt.

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