(48 days)
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.
| Characteristic / Acceptance Criteria (Predicate Device) | Reported Device Performance (VariSource 200) |
|---|---|
| Intended Use | High Dose Rate Brachytherapy |
| Safe (Maximum source strength) | Tungsten Alloy 370GBq |
| Maximum Surface Dose (IEC 601-2-17: 1µGy/h @ 1m) |
§ 892.5700 Remote controlled radionuclide applicator system.
(a)
Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class II.