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CARE Contrast CT is designed to facilitate contrast enhanced CT examinations by connecting CT and injector. If CARE Contrast CT is activated, the contrast enhanced examination can be started by pressing one single start button, either at the CT scanner or at the injector. CARE Contrast CT is based on the future standard for the communication between CT and injector.

CARE Contrast CT for the SOMATOM CT Systems includes both hardware and software components. CARE Contrast CT is an optional extension to the functionality of Siemens SOMATOM Emotion and Sensation CT scanners and is designed to facilitate contrast enhanced CT examinations by connecting CT and injector. The addition of the CARE Contrast CT option to the SOMATOM scanners simply implements an interface between CT scanners and an injector. CARE Contrast CT is based on the future standard for the communication between CT and injector.

The provided text is a 510(k) summary for the Siemens CARE Contrast CT, which is an accessory to Computed Tomography Systems. The primary purpose of this device is to facilitate contrast-enhanced CT examinations by connecting CT and injector systems.

Based on the document, there is no acceptance criteria or study outlined to prove the device meets specific performance criteria in the traditional sense of a clinical or performance study for diagnostic accuracy.

The 510(k) submission primarily focuses on establishing substantial equivalence to predicate devices. This means the manufacturer is asserting that the new device is as safe and effective as a legally marketed device that does not require premarket approval. The review process for substantial equivalence typically involves demonstrating that the device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.

Therefore, most of the requested information regarding acceptance criteria, sample sizes, ground truth, and expert involvement is not available or applicable in this specific 510(k) summary because a performance study with such details was not presented.

Here's an analysis of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

• Not applicable / Not provided. The document describes a device designed to facilitate CT examinations by connecting a CT scanner and an injector. It does not present specific performance criteria or metrics (e.g., accuracy, sensitivity, specificity) for a diagnostic task for which acceptance criteria would typically be set. The device's "performance" is its ability to establish communication and allow synchronized operation, which is assumed to be functional.

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

• Not applicable / Not provided. The submission does not detail a "test set" or any data collection for a performance study. Its focus is on establishing substantial equivalence based on the device's functional description and comparison to existing predicate devices.

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 / Not provided. Since no "test set" is described, there's no mention of experts or ground truth establishment.

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

• Not applicable / Not provided. No test set or corresponding adjudication method is discussed.

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

• No. An MRMC comparative effectiveness study was not done. The device, CARE Contrast CT, is an interface solution between a CT scanner and an injector, not an AI-assisted diagnostic tool.

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

• Not applicable / Not provided. This device is not an algorithm that performs a standalone diagnostic task. It's an accessory that enables communication and workflow for contrast-enhanced CT.

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

• Not applicable / Not provided. No ground truth for diagnostic performance is mentioned as no such study was presented.

8. The sample size for the training set

• Not applicable / Not provided. As this is not an AI/ML diagnostic device, there is no mention of a training set.

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

• Not applicable / Not provided. No training set is mentioned.

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