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The Leica FL800 is a surgical microscope accessory used in viewing bypass grafts during coronary artery bypass (CABG) surgery, as well as blood flow during plastic and reconstructive surgery.

The Leica FL800 device is an accessory to the Leica surgical microscopes. It allows the surgical microscope to produce excitation light and resolve fluorescence light from the fluorescent agent ICG. The generated fluorescence signal depicts the distribution of the infrared doct in the patient's blood vessels during the operation (fluorescence video angiography).

The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria.

The document is a 510(k) summary for the Leica FL800, focusing on establishing substantial equivalence to existing devices for an extension of use into coronary vascular and bypass surgery, as well as plastic and reconstructive surgery. It clearly states:

"The Leica FL800 is an existing device which was granted market clearance by the FDA following the submission of a 510(k) pre-market notification (K061871). Leica Microsystems seeks only an extension of use into coronary vascular and bypass surgery, as well as plastic and reconstructive surgery. There will be no change to the device design, function or technical characteristics."

This means that the device's original performance and safety were established in a prior submission (K061871), and this current submission (K080612) is about expanding its indicated uses without altering the device itself. Therefore, a new study to prove specific performance metrics for this particular submission is not described because the device's fundamental performance is assumed to be established.

As a result, I cannot provide the requested information about acceptance criteria and a study proving they are met from the given text.

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