AI / CAD Experience
Intrinsic Imaging is the world leader in conducting multi-case multi-reader studies to evaluate Artificial Intelligence (AI) and Computer Assisted Detection (CAD) systems.
We provide the most efficient means for Sponsors to conduct trials to assess the clinical performance of their AI/CAD software and obtain FDA clearance.
Intrinsic Imaging is selected due to our:
- Operational excellence and experience conducting large MRMC AI/CAD trials
- Successful FDA Inspection of an MRMC AI/DL/CAD trial with zero 483
- Proven success with multiple FDA clearances of Class I-III software
- ISO 13485 certification specifically for providing services for medical device clinical trials
- Quickly source 15-30 reviewers using our network of 500+ reviewers across multiple disciplines and specialties
- Ability to effectively and efficiently manage 6,000-20,000 case reviews with expedited timelines
- ISO Certified quality management system
To have Intrinsic Imaging manage your AI/CAD clinical trial, please contact Intrinsic Imaging at Contact@IntrinsicImaging.com or call us at 1-978-798-2400.
Recent AI / CAD Trials
We have successfully completed many MRMC AI/CAD trials to determine whether the diagnostic accuracy of readers aided by Artificial Intelligence the CAD software was superior to reader’s accuracy when unaided by CAD software. Our recent MRMC AI/CAD trials include:
- Study A was a fully crossed, MRMC AI/CAD study with no wash-out and consisted of a total of 12 readers in 2 Group Cohorts, 240 cases and 5760 reads. Intrinsic Imaging underwent a 5-day routine FDA audit with zero 483 and the CAD software was subsequently cleared by the FDA as a PMA Class III medical device.
- Study B was a fully crossed, MRMC AI/CAD study with a one month wash-out and consisted of a total of 20 readers in 4 Group Cohorts, 240 cases and 9600 reads. This study was a success and the CAD software was subsequently cleared by the FDA as a PMA Class III medical device.
- Study C was a MRMC musculoskeletal device trial to evaluate the efficacy of a spinal implant. This MRMC retrospective study consisted of a total of 28 readers and over 20,000 reads. This study was a success and the medical device is cleared in Europe and awaits clearance by the FDA as a PMA Class III medical device. A recent routine FDA audit of the study resulted in zero 483 findings.
- Study D was a fully crossed, MRMC AI/CAD study with a one month wash-out and consists of a total of 21 readers in 3 Group Cohorts, 350 cases and 14,400 reads. This study is on-going. Once completed, this study data will be submitted to FDA for clearance as a PMA Class III medical device.
- Study E was a fully crossed, MRMC AI/CAD study with a one month wash-out and consists of a total of 14 readers in 2 Group Cohorts, 320 cases and over 8960 reads. This study is on-going. Once completed, this study data will be submitted to FDA for clearance as a PMA Class III medical device.
AI / CAD Quality
Intrinsic Imaging clinical trials are conducted within Intrinsic Imaging’s ISO Certified quality management system framework.
With our portfolio of five ISO certifications certified by the British Standards Institute, Intrinsic Imaging has the most comprehensive and sophisticated quality management system in the industry.
We manage various types of Artificial Intelligence and CAD studies;
- Mammography Software
- Musculoskeletal Software
- Neurology Software
- Oncology Software
Intrinsic Imaging AI-DL-CAD Clinical Team
Amit Mehta, MD
Vice President and CMO
Richard Benedikt, MD
Bryan D. Wayne, BSc.
James Warpula, BSc.
Quality Assurance & Compliance
Heekwan Lee, BSc,
Director, Data Management
Matthew Barnes, BSc.,