Search Results

The VariSource 200 System is a High Dose Rate Brachytherapy Afterloader used to treat lesions, tumors and conditions in the body where radiation is indicated.

The VariSource 200 Series High Dose Rate Afterloader system is a computer controlled remote electro/mechanical system used for medical purposes, for placing a NiTiNol wire incorporating an irradiated iridium seed internally or close by, a malignant tumor or tumor bed in a practice known as brachytherapy.

The provided document is a 510(k) summary for the VariSource 200 HDR Brachytherapy Afterloader, which is a medical device used for radiation therapy, specifically brachytherapy. It is not an AI/ML device, and thus the acceptance criteria and study information typically associated with AI/ML device performance (like sensitivity, specificity, MRMC studies, ground truth establishment by experts, training/test set sizes, etc.) are not applicable or provided in this document.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (VariSource K - K945383) by comparing technological characteristics and meeting relevant safety standards.

Therefore, I cannot provide the requested information regarding AI/ML device performance criteria.

However, I can extract the comparison chart that outlines the device's characteristics and how it compares to its predicate, essentially serving as a form of acceptance criteria for a non-AI medical device.

1. A table of acceptance criteria and the reported device performance

For a traditional medical device like the VariSource 200 HDR Brachytherapy Afterloader, "acceptance criteria" are typically defined by regulatory standards (like IEC 601-2-17) and by demonstrating substantial equivalence to a predicate device. The performance is assessed against these established characteristics and safety thresholds.

Ask a specific question about this device