Evaluation of clinical data and regulatory submission characteristics for neuromodulation devices approved via the 510(k) pathway (1996-2024).

초록

The 510(k) pathway is prevalent for medical device approval, yet its integration of clinical data, especially in neuromodulation devices, remains underexplored. We evaluated neuromodulation devices approved via the 510(k) pathway from 1996 to 2024. Using Natural Language Processing, we traced predicate networks and analyzed clinical data inclusion. Published clinical data were also reviewed. Among 715 medical devices, 31 neuromodulation devices were identified, with 30 having summary documents.