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Intended for the irradiation of blood or blood products packaged in transfusion bags in accordance with "Recommendations Regarding License Amendments and Procedures for Gamma Irradiation of Blood Products" (22 July 1993 memorandum from Acting Director Office of Blood Research and Review, Center of Biologics Evaluation and Research, FDA to all registered blood establishments) when irradiation to reduce the risk of Graft Versus Host Disease is indicated.

The RS 3400 Rad Source X-ray Blood Irradiator consists of a shielded enclosure containing one x-ray tube capable of emitting radiation in a 360 degree output around its cylindrical design, a power supply and controller. A carousel capable of holding 5 cylindrical containers rotates those cylinders around the cylindrical x-ray tube radiation source causing the blood products contained therein to be irradiated.

Here's a breakdown of the acceptance criteria and the study information based on the provided document:

The document describes a 510(k) premarket notification for the RS 3400 Rad Source X-ray Blood Irradiator, seeking substantial equivalence to a predicate device, the RS 3000 Shielded Cabinet X-ray Radiation Source (K974210). Since this is a submission for an X-ray irradiation device, not an AI/ML medical device, many of the standard questions regarding AI/ML acceptance criteria, reader studies, and ground truth establishment for diagnostic performance are not applicable.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on demonstrating substantial equivalence to its predicate for safety and effectiveness in irradiating blood products. This is primarily evaluated through measurable technical characteristics and the ability to achieve the required radiation dose.

Study Information

For this type of device (X-ray blood irradiator), the "study" is primarily a non-clinical performance evaluation focused on the physical characteristics and radiation output, rather than a clinical trial with patient outcomes or an AI/ML performance study.

1. Sample size used for the test set and the data provenance:

   • The "test set" here refers to the materials used for non-clinical testing. The document states: "...the tests performed include measuring the radiation field resulting within the rotating containers when a blood product (using water as a sample) is contained within the rotating containers."
   • Sample Size: Not explicitly quantified as a number of distinct "samples" in the same way an AI/ML study would. The testing involves using water as a proxy for blood products in the containers.
   • Data Provenance: The tests were conducted internally by the manufacturer (Rad Source Technologies, Inc.) as part of their non-clinical performance data submission. No country of origin for external data is mentioned, as it's an internal test. It's a prospective test conducted on the device itself.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable (N/A) for this device type. The "ground truth" for an X-ray irradiator is established by physics measurements (e.g., dose rates, dose ratios, radiation field uniformity) according to accepted standards and regulatory guidance for such devices. It doesn't involve expert interpretation of images or clinical data.

3. Adjudication method for the test set:

   • N/A for this device type. Adjudication methods (like 2+1, 3+1) are used in studies where human interpretation of data is involved, especially to establish ground truth for AI/ML models. For an X-ray irradiator, physical measurements are objective and don't typically require adjudication.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No. This is an X-ray irradiation device, not an AI/ML diagnostic or assistive tool. MRMC studies are not relevant.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • N/A. This is a hardware device for irradiating blood, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" (or verification) used is based on physical measurements of radiation dose and field distribution, assessed against established regulatory guidelines and the performance of the predicate device. The 22 July 1993 memorandum on gamma irradiation for blood products also serves as a key reference for expected performance.

7. The sample size for the training set:

   • N/A. This is not an AI/ML device, so there is no "training set."

8. How the ground truth for the training set was established:

   • N/A. As there is no training set for an AI/ML model, this question is not applicable.

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