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The UDI 1417W System is a Direct Digital Radiography Upgrade unit used to directly capture and conventional projection images from an X-ray source to digital images. The result is a diagnostic image, viewable on a computer monitor, without the time and costs involved with film or cassette handling. The image can be further manipulated on the computer monitor via imaging software, can be printed and/ or e-mailed. The UDI 1717 unit provides Digital Radiographic (DR) images for every general radiographic application in hospitals, clinics and imaging centers. The portable, Wireless 14" x 17" sensor plate captures large patient imaging and areas. The UDI 1417W cannot be used for Mammography applications.

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The provided text is a 510(k) premarket notification letter from the FDA for a medical device called "Universal Digital Interface-Wireless (UDI 1417 W)". This document is a clearance letter, not a study report. It confirms that the device is substantially equivalent to legally marketed predicate devices.

Therefore, this document does not contain the detailed information requested regarding:

• Acceptance criteria table and reported device performance
• Sample sizes used for test and training sets
• Data provenance
• Number of experts for ground truth and their qualifications
• Adjudication method
• MRMC comparative effectiveness study results or effect sizes
• Standalone algorithm performance
• Type of ground truth used
• How ground truth for training set was established

This type of information would typically be found in a separate Premarket Notification 510(k) Summary or the Design Validation Report submitted as part of the 510(k) application, not in the FDA's clearance letter itself.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...". This means the FDA compared the UDI 1417W to existing, legally marketed devices and found them to be similar enough in terms of safety and effectiveness, based on the data submitted by Meridian Medical Systems. The letter itself does not describe the specific studies and their results that led to this determination.

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