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The intended use of the device Giotto Class is to produce digital images suitable for screening and diagnostic examination of the breast for detection of breast cancer.

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This is an FDA 510(k) clearance letter for a Full-Field Digital Mammography (FFDM) system called "Giotto Class." The provided document does not contain the acceptance criteria for a device, nor does it describe a study that proves the device meets specific performance criteria.

The letter confirms that the FDA has determined the "Giotto Class" device is "substantially equivalent" to legally marketed predicate devices for the indicated use of producing digital images suitable for screening and diagnostic examination of the breast for detection of breast cancer. Substantial equivalence is the pathway for clearance, meaning the device performs as safely and effectively as an already legally marketed device, but it does not require a demonstration against specific, quantitative performance criteria as would be found in a clinical trial report.

Therefore, I cannot provide the requested information from the given text. The document is solely a regulatory clearance for market access based on substantial equivalence.

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