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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 < 50 Gy as required by US clinics, hospitals and blood banks. The RADGIL 2 US has a lockable panel to ensure that only authorized personnel make adjustments.

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 < 50 Gy.
• Irradiation Method: One X-Ray tube with a rotating canister.
• X-Ray Tube Voltage/Current: 180-200 Kv, 5-20 mA.
• Dose Rate: Up to 6.0 Gy/min.
• Max/Min Dose Ratio: Less than 1:1.5.
• Radiation Safety: Pb shielding, interlocks.
• Radiation Leakage: <1.0 µSv/h.
• Compliance with Standards: UL 61010-1, IEC 61010-2-091, 21 CFR 1020.40, etc.

Below is a table summarizing the "acceptance criteria" and "reported device performance" purely based on the physical and non-clinical specifications mentioned in the document, as no clinical performance data is available.

Acceptance Criteria and Reported Device Performance for RadGil2 US (Based on Non-Clinical Specifications)

Regarding the specific questions about clinical performance and AI/algorithm validation, the document explicitly states "Clinical Performance Test Summary None," meaning these data points are not provided or applicable for this submission:

1. A table of acceptance criteria and the reported device performance: Provided above for non-clinical and physical performance. Clinical/AI performance data is not available.
2. Sample sized used for the test set and the data provenance: Not applicable for clinical performance. Clinical test sets are not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set where ground truth based on expert consensus would be established.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: "Clinical Performance Test Summary None." No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: "Clinical Performance Test Summary None." This device is a radiation therapy device, not an AI/CADe algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

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