Locked Algorithm

USA: FDA – We define a “locked” algorithm as an algorithm that provides the same result each time the same input is applied to it and does not change with use. Examples of locked algorithms are static look-up tables, decision trees, and complex classifiers (Source: “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) – Discussion Paper and Request for Feedback”, April 2019)

“Locked” algorithms are those that provide the same result each time the same input is provided. As such, a locked algorithm applies a fixed function (e.g., a static look-up table, decision tree, or complex classifier) to a given set of inputs. These algorithms may use manual processes for updates and validation (Source: “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) – Discussion Paper and Request for Feedback”, April 2019)

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