YY/T 1907-2023Artificial intelligence medical device - Coronary CT image processing software - Algorithm performance test methods (English PDF)
人工智能医疗器械 冠状动脉CT影像处理软件 算法性能测试方法
This is a limited preview
Buy now to download the full PDF (34 pages)
Need quotation for your management?
Get a formal quotation for YY/T 1907-2023 in 30 minutes.
Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
September 5, 2023
Implementation date
September 15, 2024
Scope
YY/T 1907-2023 is the English-translated version of 人工智能医疗器械 冠状动脉CT影像处理软件 算法性能测试方法.
YY/T 1907-2023 is the Chinese standard "Artificial intelligence medical device - Coronary CT image processing software - Algorithm performance test methods". Its scope clause reads: This document describes the algorithm performance testing method of coronary CT image processing software using artificial intelligence technology.
This document applies to software products that use artificial intelligence technology to post-process coronary CT images. This document is not suitable for image pre-processing and process optimization.
CCTA) and CT plain imaging. Its clauses include normative reference documents; terms and definitions.
Found what you need?
Document preview — YY/T 1907-2023
National Standard of the People's Republic of China
- ICS
- 11.040.99
- Classification
- C30
Issued by: National Medical Products Administration
Contents
- Foreword
- 1 Scope
- 2 Normative reference documents
- 3 Terms and definitions
- 3.
1 Scope
This document describes the algorithm performance testing method of coronary CT image processing software using artificial intelligence technology.
This document applies to software products that use artificial intelligence technology to post-process coronary CT images.
This document is not suitable for image pre-processing and process optimization.
CCTA) and CT plain imaging.
2 Normative reference documents
The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, the dated quotations
For undated referenced documents, only the version corresponding to that date applies to this document; for undated referenced documents, 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 Quality requirements and evaluation of artificial intelligence medical devices Part 2.General requirements for data sets
YY/T 1833.3 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, YY/T 1833.2, YY/T 1833.3 and the following apply to this document.
3.1 coronary
A curve formed along the axis of the blood vessel and connecting the lumen center points on each cross-sectional image of the coronary artery. The starting point of the curve is the crown
The opening of the coronary artery, the end point is the clearly identifiable farthest end of each coronary artery.
Note. The coronary artery centerline is generally presented on curved images.
3.2
Fractional flow reserve calculated from coronary CT vascular images.
Note. Appendix A provides additional explanation of fractional flow reserve.
3.3
A quantitative index to calculate the degree of coronary artery calcification, usually using ECG gating before coronary CT angiography.
CT plain scan (axial scan), combined with mathematical formulas to quantify coronary artery calcification.
Note 1.Currently commonly used calculation methods include Agatston integral, volume integral and mass integral.
Note 2.Agatston score is a commonly used indicator of coronary artery calcium score. Appendix B provides a supplementary explanation of its calculation method.
Note 3.Coronary artery calcification is characterized based on the lesion size exceeding a certain area or volume threshold and the density exceeding the prescribed CT value threshold. Different calculation methods
Not all the same, the guide recommends using Agatston points.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 34 pages — is available in the English PDF.
Referenced standards
Normative references
- YY/T 1833.1Artificial intelligence medical device—Quality requirements and evaluation - Part 1: Terminology
- YY/T 1833.2Artificial intelligence medical device—Quality requirements and evaluation - Part 2: General requirements for datasets
- YY/T 1833.3Artificial intelligence medical device—Quality requirements and evaluation - Part 3: General requirement for data annotation
How to Download YY/T 1907-2023
- 1
Add to cart
Click "Download PDF" on this page and choose "Buy this standard". You can add more standards before checkout.
- 2
Checkout
Enter your email and billing details. Payment is processed securely by Stripe (cards or bank transfer). Prefer bank details? Request a quotation (min. order $300).
- 3
Instant delivery (0–9 sec)
Delivery is automatic: within seconds of payment you'll receive an email with a secure download link. The link stays valid for 72 hours.
- 4
Invoice included
A tax invoice is attached to the confirmation email. Need a custom invoice? Contact us.
Related Standards
YY/T 1833.1-2022 — Artificial intelligence medical device—Quality requirements and evaluation - Part 1: Terminology
YY/T 1833.2-2022 — Artificial intelligence medical device—Quality requirements and evaluation - Part 2: General requirements for datasets
YY/T 1833.3-2022 — Artificial intelligence medical device—Quality requirements and evaluation - Part 3: General requirement for data annotation
Secure payment via Stripe
Payments accepted
YY/T 1907-2023
$300.00