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This software is intended for use by qualified personnel in the Operating Room and Nurses Station. The Advanced Image and Data Archiving System (AIDA) is a Windows® based still/video image capturing, archiving, documentation system and recording of audio sequences and patient data during a procedure. It allows capture and annotation of the surgical procedure for documentation purposes. Images captured and distributed by AIDA are for viewing and reference purposes and are not intended for primary diagnosis.

It is also a Windows® based solution to communicate with other picture archival communication systems (PACS) using DICOM and with Hospital Information Systems (HIS) using the HL7 standard. Also as a part of the AIDA system the Storz Application Manager software (SAM) enables the selection and integrations of AIDA functions with various compatible applications, such as Karl Storz's Storz Communication Bus (SCB) or other third party image capturing devices.

The Karl Storz AIDA/DICOM/HL7 is an image capturing device with DICOM viewer which communicates with the Hospital Information System via HL7 protocol.

The provided text does NOT include information about acceptance criteria, device performance, or any studies addressing these aspects.

The document is a 510(k) summary for a Picture Archiving and Communications System (AIDA/DICOM/HL7) and focuses on establishing its substantial equivalence to a predicate device. It describes the device, its intended use, and general safety and effectiveness concerns related to its software design and risk management, but it does not detail any performance studies with acceptance criteria.

Therefore, I cannot populate the requested tables and information based on the provided text.

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