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YY/T 1833.5-2024Artificial intelligence medical device - Quality requirements and evaluation - Part 5: Pre-trained models (English PDF)

人工智能医疗器械质量要求和评价第5部分：预训练模型

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

September 29, 2024

Implementation date

October 15, 2025

Scope

YY/T 1833.5-2024 is the English-translated version of 人工智能医疗器械质量要求和评价第5部分：预训练模型.

YY/T 1833.5-2024 is the Chinese standard "Artificial intelligence medical device - Quality requirements and evaluation - Part 5: Pre-trained models".

Its scope clause reads: This document specifies the general quality requirements for pre-trained models used in artificial intelligence medical devices and describes the corresponding evaluation methods.

This document applies to pre-trained models used in artificial intelligence medical devices. This document is not intended for evaluation of the development process of pre-trained models. Its clauses include terms and definitions.

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Document preview — YY/T 1833.5-2024

National Standard of the People's Republic of China

ICS: 11.040.99
Classification: C30

Issued by: National Medical Products Administration

Preface
Introduction
1 Scope
2 Normative references
3 Terms and Definitions
4 Pre-training model description requirements
5 Pre-trained model quality characteristics
6 Pre-training model quality compliance evaluation method
Appendix A (Informative) Extended description of pre-training related elements
Appendix B (Informative) Model Description Example

1 Scope

This document specifies the general quality requirements for pre-trained models used in artificial intelligence medical devices and describes the corresponding evaluation methods.

This document applies to pre-trained models used in artificial intelligence medical devices.

This document is not intended for evaluation of the development process of pre-trained models.

2 Normative references

The contents of the following documents constitute essential clauses of this document through normative references in this document.

For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to

This document.

YY/T 1833.1 Quality requirements and evaluation of artificial intelligence medical devices Part 1.Terminology

YY/T 1833.2-2022 Quality requirements and evaluation of artificial intelligence medical devices Part 2.General requirements for data sets

YY/T 1833.3-2022 Quality requirements and evaluation of artificial intelligence medical devices Part 3.General requirements for data annotation

3 Terms and definitions

The terms and definitions defined in YY/T 1833.1 and the following apply to this document.

3.1 Pre-trained model

A computational model that has been trained on a dataset and can be used as the basis for new tasks.

Note. Pre-trained models are usually used for transfer learning in a narrow sense, where the model is pre-trained on a source task and then fine-tuned on a downstream task;

In a broad sense, a pre-trained model may be used as the initial value of a machine learning model for fine-tuning of downstream tasks.

The source and category are described in an expanded manner.

3.2

Documentation describing various properties of the pretrained model.

3.3 taskdomaintaskdomain

The domain of the specific problem or task that the machine learning model needs to solve.

Note. In the application of artificial intelligence medical devices, examples of task domains include. image lesion detection, imaging sign classification, image ROI (region of interest) classification, segmentation, ultrasound video segmentation, image report generation, ECG signal detection, image generation, process optimization, etc.

3.4 Source Task

Initial tasks for training machine learning models.

Note. A.2 explains the relationship between source tasks, downstream tasks, and pre-trained models.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 24 pages — is available in the English PDF.

Referenced standards

Normative references

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