I would like to add to the discussion by talking about my experience with 510k submissions. It definitely is possible for companies to embellish characteristics of an implant or testing results to claim equivalency to a predicate device. We had a situation at work where we bought out a startup company that had a device that was currently being marketed and had been approved through a 510k. We replicated the testing that they had performed on the device and were not able to get similar results to the data that they had submitted to FDA. However, when companies act unethically like this, they are taking a high risk of having product failures in the field, and this product that I mentioned earlier is a good example of this. After we acquired the product, it had multiple issues in the field, and we ultimately had to recall the product.