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Making the Invisible Visible. Building the 510(k) Predicate Graph. Introduction.
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Making the Invisible Visible Building the 510(k) Predicate Graph
Introduction The 510(K) process of the US Food and Drug Administration (FDA) [1] allows manufacturers to demonstrate that a device is as safe and effective as one or more similar marketed devices, which are commonly known as “predicates". From the 510(K) submissions, we can easily extract the list of predicates for a particular device. However, given a predicate device, it is harder to get a list of all the devices that depend on it. The lack of a global dependency graph may hide critical information about the inheritance relationship between devices. [1]U.S. Food and Drug Administration. Premarket notification (510k). http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm, Visited June 2013.
Building the 510(k) Predicate Graph Build Hierarchical Graph to show Ancestry Relationship Process Optical Character Recognition Search for K-numbers Error testing The process of OCR and searching for K-numbers may cause errors of the predicate devices found. According to the testing, the false negative error rate is 10% and false positive rate is 3%.
For example, the graph above shows the equivalence relationship of a type of face masks. Each node is the unique identifier (known as the K-number) of a medical device. The edges from a node point to its predicate device(s). Likewise, the edges to the node trace the dependents of the device. Notice that K041855 on the bottom left can be immediately identified of having a large number of dependents. Also note that K100800 on the top right has a redundant path to K051291.
Redundant Paths In the 510(k) predicate graph, we define a redundant path to be another path from one device and its predicate besides the edge connecting them. This graph shows the number of paths from a device to each of its devices. Thus, the number of redundant paths is one fewer.
Number of Predicates and Number of Dependents Edges from a node point to its predicate devices. Likewise, edges to a node connects the devices that are dependent on that device. By counting the edges, we can know the number of predicates of each device and also the number of its dependents. This graph shows the degree of both in and out edges of each device.
