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ExaPACS is a web-based distributed software that manages the archival, retrieval, and distribution of medical images and relevant information such as patient demographics and examination on an within the system and other DICOM-compliant imaging devices including CT scanners, MR imager, CR systems, and image viewing workstations among a Picture Archive Communication System (PACS) environment for specific purposes such as telecommunications, fast demonstration, tele-consultation, eic.

ExaPACS is intended for the manipulation, management, display of medical images, and to make that information, whether included textual reports or not, available across a network via web nart whan interfaces.

Lossy compressed mammographic images are not intended for diagnostic review. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images.

ExaPACS is a web-based distributed software that manages the archival, retrieval, and distribution of medical images and relevant information such as patient demographics and examination on an within the system and other DICOM-compliant imaging devices including CT scanners, MR imager, CR systems, and image viewing workstations among a Picture Archive Communication System (PACS) environment for specific purposes such as telecommunications, fast demonstration, tele-consultation, eic.

ExaPACS is intended for the manipulation, management, display of medical images, and to make that information, whether included textual reports or not, available across a network via web nart whan interfaces.

The provided text is related to a 510(k) premarket notification for a device called "ExaPACS". This document is an FDA letter recognizing the substantial equivalence of the device.

However, the letter from the FDA does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria. The letter focuses on the regulatory approval process, stating that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed.

It details:

• The device name (ExaPACS)
• The regulation number and name (21 CFR 892.2050, Picture archiving and communications system)
• The regulatory class (II)
• The product code (LLZ)
• The date of the letter and the receipt of the 510(k) application
• General controls provisions of the Act
• Instructions for labeling regulations and reporting adverse events

The "Indications for Use" section describes what the device does (manages, archives, retrieves, and distributes medical images and related information within a PACS environment) and its intended users, but it does not specify performance metrics, acceptance criteria, or any study results. It also includes a warning about lossy compressed mammographic images not being intended for diagnostic review.

Therefore, based only on the provided text, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets those criteria. The necessary information is not present in the FDA 510(k) clearance letter.

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