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ESSENPACS is a software package intended for acquisition, processing, archiving, transmitting and viewing DICOM Compliant medical images (including mammographic images). It receives digital images and data from various sources (including CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.

Lossy compressed or digitized screen film mammographic images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using a FDA approved monitor that offers at least 5 Mpixel resolutions and other technical specifications reviewed and accepted by FDA.

ESSENPACS is a DICOM-compliant and server/client architectural software application. It is a distributed image management system that manages the viewing, retrieval, manipulation, and distribution of medical images within a Picture Archiving and Communication System (PACS) environment. ESSENPACS is implemented on base of the Digital Imaging and Communication in Medicine (DICOM) standard. Therefore, the system provides communications of images and relevant information such as patient demographics and examination data between DICOM-compliant imaging devices and itself.

The provided 510(k) summary for ESSENPACS™ does not contain information on acceptance criteria or a study proving that the device meets specific performance criteria. This type of 510(k) submission generally focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and intended use, rather than presenting detailed performance studies with acceptance criteria.

The document primarily describes the device's function as a Picture Archiving Communications System (PACS) and its DICOM compliance. It also identifies a predicate device (STARPACS™ K011013) and claims substantial equivalence to it.

Therefore, the specific information requested in the prompt, such as

• A table of acceptance criteria and reported device performance
• Sample sizes and data provenance for test sets
• Number and qualifications of experts for ground truth
• Adjudication method for the test set
• MRMC comparative effectiveness study results
• Standalone algorithm performance
• Type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

are not present in the provided text.

The conclusion states: "The 510(k) Pre-Market Notification for ESSENPACS™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device." This indicates that the FDA's decision was based on a comparison of the device's characteristics and indications for use to a previously cleared similar device, not necessarily on a detailed performance study against specific acceptance criteria.

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