New: QIBA Conformance Certification Service for CT Analysis Vendors

Medical scanners and image analysis software systems are now routinely being used to obtain precise quantitative image measurements, which can often play a major role in patient care. It is therefore critical that CT analysis vendors demonstrate that their image analysis software has been thoroughly evaluated to achieve high levels of performance for specific measurement tasks. The Radiological Society of North America’s (RSNA) Quantitative Imaging Biomarkers Alliance (QIBA®) has developed specification documents, called Profiles, that specify the requirements and technical performance needed for quantitative image measurement tasks. QIBA® is now working closely with Accumetra to provide a new QIBA® Conformance Certification Service that enables CT analysis vendors to verify conformance with a QIBA® Profile and receive a QIBA® Conformance Certification Mark that can be used to communicate the achievement.

QIBA® has developed the QIBA CT Small Lung Nodule Profile along with a new QIBA® Conformance Certification Service. The Profile provides a comprehensive set of specifications to ensure that a clinical site attains a minimum level of quantitative imaging performance necessary to achieve a specified lung nodule volume measurement accuracy. The QIBA® Conformance Certification Service for the CT Small Lung Nodule Profile provides conformance certification specifications needed to show that a CT software analysis application is able to achieve high quality lung nodule measurements. After signing up an FDA approved CT analysis software application for this service, CT software analysis vendors are provided performance evaluation testing datasets and instructions for performing a set of CT small lung nodule measurements that demonstrate measurement performance over a range of nodules sizes. The conformance results are then used to provide customers with independently performed verification that a specific CT analysis software application is conformant with the QIBA® CT Small Lung Nodule Profile. In addition, the software analysis vendor receives a QIBA® Conformance Certification Mark that can be used for marketing and promotion.

To use this service and obtain an institution-specific QIBA® Conformance Certification Mark for an FDA approved CT analysis software version, a CT analysis software vendor must register and pay $6,000 + tax for each year of conformance certification services.

Benefits of obtaining a QIBA® Conformance Certification Mark for a CT Analysis Software Vendor:

• Demonstrate to your current and potential customers that your medical device or software meets the thorough specifications outlined in a QIBA® Profile
• Annually verify the performance of your medical device helping ensure that the high performance remains consistent under a variety of acquisition and measurement conditions.
• Provide quantitative and independently confirmed device data to your customers on the best methods and protocols to use with your medical device.
• Promote your high-performance, quantitative imaging capability by posting the QIBA® Conformance Certification Mark to your medical device or software web pages and promotional materials.
• Participation will help improve future CT lung cancer imaging guidelines.

Contact Accumetra at info@accumetra.com for additional information on these services.

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