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The MEDRAD® Imaging Bulk Package Transfer Set (IBP Transfer Set) is indicated for the transfer of ULTRAVIST® (Iopromide), ISOVUE® (Iopamidol), and OMNIPAQUE™ (Iohexal) contrast media as supplied in an approved Imaging Bulk Package (IBP) presentation to empty sterile syringes on single-use only syringe-based contrast power injection systems indicated for the controlled, automatic venous administration of contrast agents for CT procedures. The Transfer Set is to be discarded after one of the following conditions has occurred first; the contrast media container has been depleted, the contrast media use time has expired, or 10 hours has elapsed since the container was penetrated.

The MEDRAD ® Imaging Bulk Package Transfer Set is a pre-administration filling device that is designed to transfer fluid from an imaging bulk package into multiple sterile syringes via a powered injector system prior to a CT procedure. There is no direct patient contact with the use of this device. It is intended to spike one bulk package of iodinated contrast media only. Each imaging bulk transfer set consists of a spike, flexible tubing, and a swabbable valve. The transfer set is provided sterile, individually packaged, and is not intended to be resterilized.

The MEDRAD® Imaging Bulk Package Transfer Set is not an AI device, therefore, the requested information regarding AI device performance, sample sizes for training and test sets, expert involvement, and ground truth establishment is not applicable.

This device is an intravascular administration set designed for transferring contrast media. The provided document focuses on its substantial equivalence to a predicate device, as required for a 510(k) submission to the FDA.

Here's the relevant information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance (Non-AI related):

• ISO 594-2:1998 (Conical fittings with 6% Luer taper)
• ISO 8536-4:2007 (Infusion sets for single use, gravity feed) | Complies with the standards |
  | Additional Performance Testing:
• Microbial ingress testing (Swabbable Valve, Bottle Septum, Spike, Syringe) at T=0, 4, 10, 14 hrs, and bottle depletion
• Chemical compatibility and injectable particulate (Evaluation of conformance to approved release specifications of ULTRAVIST® and USP monographs for ISOVUE® and OMNIPAQUE™)
• Material compatibility (Evaluation under worst-case conditions and simulated use with ULTRAVIST® 370 as solvent for leachable compounds) | Complies with its predetermined specifications |

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

• This device is not an AI/software device, so there isn't a "test set" in the traditional sense of a dataset for algorithm evaluation.
• The performance "testing" refers to bench testing, sterilization validations, and biocompatibility assessments of the physical device components and its interaction with contrast media. The document does not specify the sample sizes for these physical and chemical tests, which is common for this type of submission.
• Data provenance is from internal testing and validation by Bayer U.S. LLC, an American company. The tests are prospective in nature, as they are conducted to validate the new device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

• Not applicable, as this is not an AI device relying on expert review of clinical data for ground truth. The "ground truth" for this medical device comes from established industry standards (e.g., ISO standards) and specified performance criteria for physical and chemical properties.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable, as this is not an AI device.

5. 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:

• Not applicable, as this is not an AI device.

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

• Not applicable, as this is not an AI device.

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

• For physical product testing, the "ground truth" is defined by established international standards (e.g., ISO, USP monographs), internal design specifications, and validated test methods. Compliance implies that the device meets these pre-defined, objectively measurable criteria (e.g., sterility level, material compatibility, functional performance).

8. The sample size for the training set:

• Not applicable, as this is not an AI device.

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

• Not applicable, as this is not an AI device.

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