Template

Instructions On Data Acquisition (Machine Learning / AI)

Sven Piechottka · IEC 62304 Templates · Published November 15, 2023

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Instructions on Data Acquisition

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, (...)

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Sven Piechottka

Sven Piechottka

With a background in political and administrative sciences, my way into regulatory affairs started from a different angle. I focused on the promises of precision medicine during my final year of studies and first joined IBM to help leverage healthcare innovation projects across Germany.

 I then gained most of my regulatory experience while working for Vara (before: Merantix Healthcare), where we built up a quality management system from scratch. For about three years, I coordinated regulatory affairs, led the ISO 13485 certification and CE certification of an AI-based radiology software, and served as data protection officer and quality management officer of the company.
More about me