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This document sets requirements for assessing AI and AuI systems used with 2D radiographs
Based on the variety of combinations arising from the test strategy, test metrics, assessment levels and AI outputs, the real accuracy and usability of AI applications can often only be assessed with difficulty because every product is designed and assessed differently. This document provides manufacturers and other relevant groups requirements regarding the assessment of AI products in the field of 2D radiographs in dentistry. No minimum results (in terms of pass/fail criteria) are provided here, while requirement for carrying out and describing the tests and their results are provided. This is intended to result in greater transparency and comparability of the assessment of AI products from various manufacturers. AI systems must be transparent and trustworthy by providing users with explainability tools and thorough documentation of model tuning, thereby ensuring safety, reproducibility, and compliance. Together with ISO 18374, which provides, among other things, explanations about the test data sets, the aim is obtain a more valid, more reliable and more comparable assessment of AI products in the field 2D radiographs in dentistry
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