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dicomPACS® and dicomPACS®DX-R are software systems for the administration, archiving, processing, improvement and compression of medical image data for diagnosis. The images are either acquired from imaging modalities via DICOM or imported directly. All images are archived in a database as DICOM compliant files. The data is displayed on a computer monitor for diagnosis. dicomPACS® and dicomPACS® DX-R also provides services for administering the data.

dicomPACS® DX-R can control X-ray generators. dicomPACS®DX-R is not approved for the acquisition of mammographic image data.

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

Functions to be carried out using dicomPACS® and dicomPACS® DX-R are, for example, but not limited to adjustment of window leveling, rotation, zoom, and measurements.

dicomPACS® and dicomPACS®DX-R are meant to be used by qualified medical personnel only. All users must be qualified to create and diagnose radiological image data.

dicomPACS® and dicomPACS®DX-R are software systems for the administration, archiving, processing, improvement and compression of medical image data for diagnosis. The images are either acquired from imaging modalities via DICOM or imported directly. All images are archived in a database as DICOM compliant files. The data is displayed on a computer monitor for diagnosis. dicomPACS® and dicomPACS® DX-R also provides services for administering the data.

dicomPACS® DX-R can control X-ray generators.

The software comes in two varieties - as dicomPACS® 5.2. and as dicomPACS® DX-R 1.6. While dicomPACS® DX-R 1.6 provides some functionality like generator control, CR/DR acquisition and raw data processing, dicomPACS® does not have these functions.

The provided text is a 510(k) summary for the dicomPACS® 5.2 and dicomPACS® DX-R 1.6 devices. It describes modifications made to the device and asserts substantial equivalence to a predicate device, but it does not contain acceptance criteria for device performance or a study demonstrating that the device meets such criteria.

The document primarily focuses on:

• Administrative information about the submission.
• Indications for Use for the updated devices.
• A functional comparison table highlighting new features in the updated versions.
• Identification of "significant changes" to the device (Multiplanar Reconstruction, CR/DR acquisition, and Raw data processing).
• A "Substantial Equivalence Conclusion" stating that the modifications do not alter the Indications for Use, fundamental scientific technology, or introduce new safety/effectiveness questions.
• The FDA's letter of substantial equivalence.

Therefore, I cannot provide the requested information from the provided text. The document is an application for market clearance based on substantial equivalence, not a performance study report.

No information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for either training or test sets is present in the provided text.

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