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Indicated for Contrast Media Administration in Angiographic procedures.

The Dye Management® System is comprised of two (2) components namely; 1) a dye management set with contrast spikes. 2) A dye management set with in-line reservoir. The Dye Management® system is configured by attaching the reservoir set to either the one (1) or two (2) spike set.

The provided text describes a Special 510(k) submission for the ICU Medical Dye Management® System. This submission is for a medical device (catheter lab kit, angiography kit, dye management set) and not for an AI/ML powered device. As such, the specific criteria requested for AI/ML device studies (such as MRMC studies, standalone algorithm performance, number of experts for ground truth, sample sizes for training/test sets, data provenance, etc.) are not applicable or mentioned in this type of submission.

Therefore, the response will focus on the information available in the provided text regarding device acceptance and the supporting study, while explicitly stating where AI/ML-specific information is not present.

Acceptance Criteria and Device Performance for ICU Medical Dye Management® System

1. Table of Acceptance Criteria and Reported Device Performance

Study Information (as applicable to a medical device submission, not AI/ML):

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• The document does not specify a sample size for an explicit "test set" in the context of clinical data for AI/ML. The testing mentioned refers to device component integrity (alternate burette). No information on data provenance (country, retrospective/prospective) is provided, as this is not a study involving clinical data for algorithmic performance.

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. This is a submission for a physical medical device, not an AI/ML algorithm requiring expert-established ground truth for performance evaluation.

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

• Not applicable. Adjudication methods are typically relevant for clinical studies involving multiple readers for diagnostic accuracy, which is not the focus of this device submission.

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. This is not an AI/ML device, and no MRMC study is mentioned.

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

• Not applicable. This is a physical medical device. No standalone algorithmic performance is relevant.

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

• The "ground truth" here is based on engineering and manufacturing specifications and functional testing of the device components (specifically, the alternate burette) and comparison to established predicate devices. It is not clinical ground truth in the sense of diagnostic accuracy.

8. The sample size for the training set

• Not applicable. There is no AI/ML training set involved for this device.

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

• Not applicable. No AI/ML training set.

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