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The Control Device (CCD) is intended for use in the IV delivery of contrast media during imaging procedures with a secondary intended use of conservation of contrast media.

The CCD is made up of two parts: Part A, which is the reusable spike assembly (intended for use on only one container of contrast media/dye and considered an extension of the contrast container) and; Part B, which is the disposable valve and tubing set (intended for use on only one patient). The two in-line backcheck valves in Part B prevent inadvertent retrograde flow thereby protecting Part A from contamination.

The provided text describes a 510(k) premarket notification for a medical device called the "Contrast Control Device" (CCD). However, it does not contain information about acceptance criteria, actual device performance (beyond intended use), specific studies conducted, sample sizes, ground truth establishment, or expert involvement.

The document primarily focuses on:

• Administrative details: Submitter information, device names, predicate devices, and the date of submission.
• Device description: How the two parts of the CCD work (reusable spike assembly and disposable valve/tubing set) and its multi-patient use protocol within a 6-hour timeframe.
• Intended use: IV delivery of contrast media during imaging procedures and conservation of contrast media.
• FDA's response: A letter confirming substantial equivalence to predicate devices and allowing marketing.
• Indications for Use statement.

Therefore, I cannot provide the requested information in the format specified because the input text does not contain the necessary data regarding performance studies or acceptance criteria.

To answer your request, I would need a section of the 510(k) or accompanying documentation that details the verification and validation (V&V) activities performed for the device. This would typically include:

• Test methods: Descriptions of how the device was tested.
• Test results: Specific quantitative or qualitative outcomes of the tests.
• Acceptance criteria: Predefined limits or conditions for the test results to demonstrate safety and effectiveness.
• Study design details: Information on sample sizes, data collection, and ground truth.

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