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DBSWIN and VistaEasy imaging software are intended for use by qualified dental professionals for windows based diagnostics. The software is a diagnostic aide for licensed radiologists, dentists and clinicians, who perform the actual diagnosis based on their training, qualification, and clinical experience, DBSWIN and VistaEasy are clinical software applications that receive images and data from various imaging sources (i.e., radiography devices and digital video capture devices) that are manufactured and distributed by Duerr Dental and Air Techniques. It is intended to acquire, display, edit (i.e., resize, adjust contrast, etc.) and distribute images using standard PC hardware. In addition, DBSWIN enables the acquisition of still images from 3rd party TWAIN compliant imaging devices (e.g., generic image devices such as scanners) and the storage and printing of clinical exam data, while VistaEasy distributes the acquired images to 3rd party TWAIN compliant PACS systems for storage and printing.

DBSWIN and VistaEasy software are not intended for mammography use.

DBSWIN and VistaEasy imaging software is an image management system that allows dentists to acquire, display, edit, view, store, print, and distribute medical images. DBSWIN and VistaEasy software runs on user provided PC-compatible computers and utilize previously cleared digital image capture devices for image acquisition.

VistaEasy is included as part of DBSWIN. It provides additional interfaces for Third Party Software. VistaEasy can also be used by itself, as a defeatured version of DBSWIN.

The provided text is a 510(k) Summary for a medical device (DBSWIN and VistaEasy Imaging Software). It describes the device, its intended use, and its similarities to a predicate device to establish substantial equivalence for FDA clearance.

However, this document does not contain information about specific acceptance criteria related to a study proving the device meets performance metrics. It focuses on demonstrating equivalence to a legally marketed predicate device rather than presenting results from a standalone performance study with defined acceptance criteria.

The "Clinical and Non-Clinical Testing" section mentions:

• "DBSWIN/VistaEasy was developed in compliance with the harmonized standard of IEC 62304 for medical device software life cycle requirements."
• "DBSWIN product has been in sales and distribution in the European dental market for over 15 years serving and performing the same intended use, functionality, and hardware compatibility interfaces with 3rd party software."
• "Bench testing, effectiveness, and functionality were successfully conducted and verified between DBSWIN and VistaEasy, and image capture devices."
• "DBSWIN is DICOM compliant."
• "Risk Analysis based design development and design reviews were conducted."
• "Full functional software cross check testing was performed."

These points indicate software development and general testing, but none of them are described as a quantitative performance study with specific acceptance criteria that would fall under the categories requested in your prompt (e.g., performance metrics like sensitivity, specificity, or reader improvement).

Therefore, based only on the provided text, I cannot answer the questions about acceptance criteria and the specifics of a study proving the device meets them because such details are not present. The clearance is based on substantial equivalence to an existing predicate device (Visix Imaging - K082623), meaning the FDA determined it performs as safely and effectively as the predicate, not necessarily through novel clinical performance studies for this specific submission.

If this were a more complex AI/ML device, the FDA would likely require a more detailed study with quantitative performance metrics as part of the 510(k) submission. This document, however, describes a "Picture archiving and communications system" which primarily functions for image management and display, and its clearance relies on demonstrating it is technologically similar and has similar indications for use as a previously cleared device.

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