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The 3-CCD Digital Camera System provides medical professionals with video capabilities for diagnostic and surgical procedures.

This device is a 3-CCD Digital Camera System utilized for medical applications. The intended use for this device is identical to that of most contemporary surgical video camera systems and accessories. The 3-CCD Digital Camera System has been designed and manufactured to meet the UL 2601.1, IEC 601-1, CAN/CSA 601.1, and EN 60601 guidelines for electrical safety.

The provided text describes a 3-CCD Digital Camera System. However, it does not include information about acceptance criteria, device performance, or a study proving that the device meets specific criteria related to its diagnostic or surgical capabilities.

The document primarily focuses on:

• Regulatory clearance: FDA clearance (K970605) for the device as "substantially equivalent" to a predicate device (K941919).
• Safety standards: Mention of meeting UL 2601.1, IEC 601-1, CAN/CSA 601.1, and EN 60601 for electrical safety.
• Intended use: "providing medical professionals with video capabilities for diagnostic and surgical procedures."

Since the document does not contain the requested information regarding acceptance criteria, performance studies, sample sizes, ground truth, or expert qualifications, I cannot populate the table or answer the specific questions.

The document is a regulatory clearance letter and a brief device description, not a performance study report.

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