(108 days)
RadGil2 US is an X-Ray irradiation device intended for use in the irradiation of blood products packaged in transfusion bags to inactivate lymphocytes for the prevention of graft vs host disease (GVHD)
The RADGIL 2 US x-ray blood irradiator is for use in Hospitals, Medical Centers and blood banks. The RADGIL 2 US x-ray blood irradiator consists of one lead-shielded cabinet containing one monoblock with one X-ray tube inside, one irradiation chamber, one control electronics, one computer for data management and one operator controls panel for the X-ray settings. The RADGIL 2 US x-ray blood irradiator is designed to accommodate a rotating canister of approximately 2.5 litres, to accommodate up to six standard 300 mL blood bags provided the bags are not frozen and the blood bag tubing is not an obstruction. The RADGIL 2 US x-ray blood irradiator is capable of irradiating the blood products to a central dose of 30 Gy, granting a minimum dose >15 Gy and a maximum dose
The provided text is a 510(k) Summary for the RadGil2 US X-ray blood irradiator. It focuses on demonstrating substantial equivalence to a predicate device (SANGRAY) based on technical characteristics and non-clinical performance tests.
Crucially, the document explicitly states "Clinical Performance Test Summary None". This indicates that no clinical studies (which would involve human participants or human-in-the-loop performance evaluations) were conducted to prove the device meets specific acceptance criteria based on human performance or diagnostic accuracy.
Therefore, the requested information regarding acceptance criteria, study that proves the device meets the acceptance criteria (specifically performance metrics like sensitivity, specificity, AUC, or reader improvement), sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth for training data cannot be extracted from this document. These types of data are typically found in clinical validation reports for AI/CADe devices, not premarket notifications for radiation-emitting medical devices like blood irradiators.
The acceptance criteria and performance data provided in this document relate solely to the physical specifications and non-clinical performance of the blood irradiator itself, such as:
- Dose Delivery: Central dose of 30 Gy, minimum dose >15 Gy, maximum dose 15 Gy |
| | Maximum Dose |
N/A