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Methodological framework demonstrates evaluation criteria for assistive neurotechnologies, highlighting the need to decouple decoder metrics from clinical outcomes.
A non-operational evidence package for assistive neurotechnology, neural interfaces, neuroimaging, materials, privacy, and algorithmic control. It separates decoder metrics from functional and population outcomes, preserves negative clinical and engineering results, and treats whole-device reliability and lifecycle cybersecurity as safety requirements. The release contains no fabrication, implantation, placement, stimulation, cognitive-enhancement, cyberattack, bypass, or unsupervised human protocol. Individual assistive results do not establish population efficacy. FDA and cited institutions are sources and do not imply affiliation, review, approval, or endorsement.
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Riccardo Giudici (2026) studied this question.
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