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The LifeJet™ Video Link is a video image digitizer for the acquisition and conversion into digital format of medical images codified as analogue video signal.

The LifeJet™ Video Link has been developed to be used together with LifeJet™ Printers to produce referral prints of images coming out from ultrasound systems or other medical equipment through the video signal output.

The LifeJet™ Video Link is a small box that integrates the functions and the hardware of a standard personal computer based on a Pentium architecture, for the purpose of acquisition and conversion into digital format of medical images codified as analogue video signal.

The provided text, K013395 for Ferrania S.p.A. LifeJet™ Video Link, does not contain information about acceptance criteria or a study proving the device meets said criteria.

The document is a 510(k) Premarket Notification summary, which focuses on demonstrating substantial equivalence to a predicate device, not on presenting performance data from a specific study against predefined acceptance criteria.

Specifically, Section 10.9, titled "Performance data," explicitly states: "Not required for this type of device and its level of concern."

Therefore, I cannot fulfill your request for the detailed information as it is not present in the provided input.

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