CDRH released guidance on what information should be included in regulatory submissions for devices that generate quantitative imaging values.
The guidance provides a general approach for developing and defining technical performance information to include in premarket submissions for devices with quantitative imaging functions.
Most images require a trained physician to identify a certain structure or feature. Quantitative imaging extracts additional information from images in the form of numerical values, such as standard uptake values in nuclear medicine and volumetric measurements in tomographic imaging in magnetic resonance imaging.
Because quantitative imaging functions have a broad range of intended uses, it is often difficult to define universal criteria for achieving a well characterized quantitative imaging function and sufficient user information, the agency says.
In general, devicemakers should provide performance specifications for the quantitative imaging functions, supportive performance data to show that the quantitative imaging functions meet those performance specifications, and sufficient information for the end user to understand the values provided, the draft guidance says.
The recommendations apply to premarket applications, humanitarian device exemption applications, 510(k) submissions and de novo requests. The guidance document is applicable to all devices that generate quantitative imaging values across a wide range of imaging modalities, intended uses, levels of automation, and complexity of algorithms.
The guidance proposes best practices for technical performance assessments, such as defining relationships between the quantitative imaging functions and the measure/use conditions and determining performance metrics such as bias, precision, limits of detection, linearity and sensitivity.
Read the guidance here: www.fdanews.com/04-26-19-QuantitativeImagingGuidance.pdf.