Instructions on Data Annotation

Intended Purpose:

The Instructions on Data Annotation specify the way in which datasets shall be annotated by medical experts to apply labelling required for the training of the machine learning model. It provides a standard annotation style, including the accuracy and form of annotation. Annotation requirements shall be specific enough to enable any given third party to evaluate the quality of annotation. The guidelines shall als provide a reasoning for the selection of labels and the methodology used to derive the ground truth for model development.

Relevant other documentation:

SOP Machine Learning Model Development
Intended Use
Instructions on Data Acquisition

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General Information

Annotation experts shall draw segmentations around the following findings:

Tumors
Other suspicious findings
(…)

Annotation experts must make sure to segment all visible findings as missing a possible findings will lead to an algorithmic classification as unsuspicious and decreased model performance.

Annotation experts shall NOT segment the following findings:

Benign finding XYZ
(…)

Tumors

Annotation instructions:

Ensure that the segmentation captures the entire tumor
(…)

Document the following information:

Tumor classification
Biopsy information
Confidence level
(…)

Other Suspicious Findings

Annotation instructions:

Ensure that the segmentation captures the entire finding
(…)

Document the following information:

Type of suspicious finding
Biopsy information
Confidence level
(…)

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