FDA grants 510(k) clearance to AI companion tool for TULSA-PRO system

The FDA has granted 510(k) clearance to the Contouring Assistant, a machine-learning-based prostate segmentation tool designed for use in conjunction with the TULSA-PRO system to assist in delineating the prostate and target ablation volume for Transurethral Ultrasound Ablation (TULSA) procedure treatment planning.¹

Profound is continuing developmental work on their next planned TULSA-AI model, TULSA BPH.

The Contouring Assistant now marks Profound Medical’s second FDA-cleared TULSA-AI module.

“The addition of a second, FDA-cleared TULSA-AI module is an important milestone as we continue to deliver on our promise to continuously improve the TULSA treatment experience for urologists and their patients. To that end, we believe that Contouring Assistant should not only increase urologists’ confidence in their treatment designs, but also significantly increase their procedural efficiency,” said Arun Menawat, PhD, Profound’s CEO and Chairman, in a news release from the company.¹

The Contouring Assistant utilizes a large database of successful physician-created TULSA treatment designs to recommend a treatment plan based on learned patterns. Specifically, the tool uses 24,611,072 parameters extracted from 7466 training images.

According to the news release from Profound, the tool has been validated in 2 clinical studies.

The first study compared the Contouring Assistant with the reference standard in 100 prostate cancer cases. Overall, the study showed that the Contouring Assistant was noninferior to the reference standard and similar to expert radiologist inter-reader variability. Further, the Contouring Assistant was able to contour all 100 prostate cancer cases with an average Sørensen–Dice coefficient of 0.910 (SD, 0.031).

The Contouring Assistant was also assessed in a multi-reader, multi-case study involving 5 radiologists and 3 urologists. Data from the study showed that the contouring accuracy of the radiologists when using the tool was noninferior to their performance without the tool. They were also 29% faster on average when using the tool. Further, the urologists in the study showed a statistically significant improvement in contouring accuracy when using the tool vs when not using the tool. They were also 32% faster on average when using the tool.

Preston Sprenkle, MD, a urologist in the study, commented in the news release,¹ “Profound is to be commended for supporting this rigorous clinical analysis of the Contouring Assistant feature, which was on par with that normally associated with testing diagnostic-level AI software. Importantly, [Contouring] Assistant not only allowed my esteemed urologist colleagues and I to approach the accuracy of an expert radiologist reader in our TULSA treatment designs, but also enabled us to reduce overall procedure times by one-third.”

The Contouring Assistant is designed to work in conjunction with the TULSA-PRO system, which was granted FDA 510(k) clearance in August 2019.²

The clearance was granted based on findings from the TACT trial, which showed that the device was effective in prostate tissue ablation with minimal adverse events. The system was also shown to significantly reduce prostate volume and prostate-specific antigen levels and achieved low rates of residual prostate disease.

In addition to these tools, Profound noted that they are continuing developmental work on their next planned TULSA-AI model, TULSA BPH. They expect to provide more details on that tool later in the year.

References

1. Profound Medical receives U.S. FDA 510(k) clearance for ‘Contouring Assistant’ AI module that enables creation of an automated TULSA treatment plan. News release. Profound Medical Corp. Published online and accessed May 14, 2024. https://www.biospace.com/article/releases/profound-medical-receives-u-s-fda-510-k-clearance-for-contouring-assistant-ai-module-that-enables-creation-of-an-automated-tulsa-treatment-plan/

2. Profound Medical receives U.S. FDA 510(k) clearance for TULSA-PRO. News release. Profound Medical Corp. August 16, 2019. Accessed May 14, 2024. https://www.globenewswire.com/news-release/2019/08/16/1903004/0/en/Profound-Medical-Receives-U-S-FDA-510-k-Clearance-for-TULSA-PRO.html