Why is performance demonstration under clinically relevant conditions necessary?

Performance demonstration under clinically relevant conditions is crucial because it ensures that any new technology, treatment, or product is effective and safe in real-world settings where it will actually be used. The clinical environment is distinct from controlled settings in many ways, including the diversity of patient cases, variations in staff experience and skill, and differences in available resources. By testing in these conditions, practitioners can assess whether the innovations can be successfully integrated into everyday dental practice and meet the needs of patients effectively.

This real-world application is foundational to establishing the credibility and reliability of new advancements in dentistry, as it reflects practical considerations that can ultimately impact patient outcomes. Therefore, fulfilling this requirement helps bridge the gap between theoretical efficacy and practical applicability, leading to better treatment protocols and improved patient care.

Satisfying legal regulations, complying with licensing agreements, or reducing user training are important considerations but do not directly address the necessity of validating performance in situations closely resembling actual clinical practice.