Performance and Safety PYLARIFY AI

Performance Characteristics
An independent and prospectively planned clinical evaluation of PYLARIFY AI
demonstrated:

• A high efficiency in producing quantitative (volumetric disease burden)
  structured report for PSMA PET/CT – median reading time 1.4
  minutes interquartile range 2.1 minutes.
• A higher reproducibility of quantitative measurements compared to
  manual state of the art – ICC2 of three independent readers was
  observed at 98% when using PYLARIFY AI, against 90% for manual
  reads.
• A better detection of lesions compared to manual state of the art – the
  pooled sensitivity of three independent readers was observed at 85%
  when using PYLARIFY AI, against 84% for manual reads.

Warnings
The user must ensure that the patient’s name, patient ID and study date displayed in the patient
section correspond to the patient case you intend to review.
The user must ensure the review of the image quality and quantification analysis results before
signing the report.
The user must review the images and quantification results in the report to ensure that the information
saved and exported is correct.
The user shall not rely solely on the information provided by PYLARIFY AI for diagnostic or treatment
decisions. The quantification analysis results provided by PYLARIFY AI are intended to be used as
complementary information together with other patient information and investigations used in the
clinical decision-making process.