Template: Instructions On Data Acquisition (Machine Learning / AI)

Sven Piechottka
Updated April 26, 2024

Template Download

This is a free template, provided by OpenRegulatory.

If you are a user of Formwork, our eQMS software, you can save a lot of time by choosing “QMS” on the top menu and “OpenRegulatory Templates” on the left menu, and then opening the relevant folder to find this template ready to load into Formwork.

If, for some mysterious reason, you’re using a different QMS Software, you can also simply download this template – specifically, as Word (.docx), PDF, Google Docs or Markdown file. Scroll down for a preview!

The template license applies (don’t remove the copyright at the bottom, don’t re-use this for commercial purposes).

Lost In Regulation? Book a Free 30-Minute Consulting Call.

Unsure how to get started and how to get your EU MDR medical device certified?
We’ve already helped hundreds of companies with their MDR compliance.
Book a free 30-minute consulting call and let’s discuss how you can get your compliance done efficienty.

Book a free 30-minute consulting call
Template preview

The Instructions on Data Acquisition define what kind of data is collected and annotated (prepared) for machine learning model development. The requirements for general data acquisition can be defined less specific than the subset of data used for annotations as any additional data can be used for future developments that are not specified yet.

Relevant other documentation:

  • SOP Machine Learning Model Development
  • Intended Use
  • Instructions on data annotation
  • Algorithm Validation Report

Acquisition

Use Context

Use context:<e.g. AI-based decision support in radiology>
Pathology:<e.g. prostate cancer>
Target numbers:For example: XXX tumor cases with biopsies, XXX benign cases, XXX healthy cases
Other information:<For example: Prefer images from certain manufacturers>
(…)(…)

Medical Specifications

Patient population:<For example: European male>
Contents of medical reports:<Applicable clinical scores, biopsy information, etc.>

Technical Specifications

Manufacturer:<Enter hardware manufacturer, e.g. Siemens>
Exclusions:For example: images other than MRI, no medical reports included
(…)(…)

Annotation Data

Inclusion criteria:For example: male patients in Europe with certain diagnoses, (…)
Exclusion criteria:For example: tumors caused by metastasis of other cancers, implants e.g. for radiation therapy, (…)

Template Copyright openregulatory.com. See template license.

Please don’t remove this notice even if you’ve modified contents of this template.

Template preview