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The UDI 1717 System is a Direct Digital Radiography Upgrade unit used to directly capture and convert 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 17" x 17" sensor plate capture large patient imaging and areas.

For the review of parts of the anatomy (legs, spine, etc.) that exceed the panel's dimensions, several Images can also be "stitched" together to allow the review of this part of the anatomy as one single image.

The UDI 1717 cannot be used for Mammography applications.

The UDI 1717 System is a Direct Digital Radiography Upgrade unit used to directly capture and convert 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 17" x 17" sensor plate capture large patient imaging and areas.

For the review of parts of the anatomy (legs, spine, etc.) that exceed the panel's dimensions, several Images can also be "stitched" together to allow the review of this part of the anatomy as one single image.

The UDI 1717 cannot be used for Mammography applications.

This document is a 510(k) premarket notification decision letter from the FDA for the Universal Digital Interface (UDI) 1717. It does not contain the detailed study information, acceptance criteria, or performance data typically found in a clinical study report or a more extensive submission summary.

Therefore, I cannot extract the requested information (1-9) from the provided text. The document primarily focuses on the FDA's decision regarding substantial equivalence based on the device's indications for use.

To obtain the requested information, you would need to consult the actual 510(k) submission document (K112527) which would contain the technical specifications, testing protocols, and performance data used to demonstrate substantial equivalence to a predicate device.

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The UDI 1717 System is a Direct Digital Radiography Upgrade unit used to directly capture and convert 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 17" x 17" sensor plate capture large patient imaging and areas. The UDI 1717 cannot be used for Mammography applications.

Universal Digital Interface (UDI) 1717

This looks like an FDA 510(k) clearance letter and an "Indication for Use" statement, not a scientific study or clinical trial report. As such, it does not contain the detailed information required to answer your questions about acceptance criteria and study results.

Here's why and what information is missing:

• No Acceptance Criteria or Performance Data: The document is a regulatory approval letter. It confirms that the device (Universal Digital Interface (UDI) 1717) is substantially equivalent to a legally marketed predicate device. It does not specify any acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or present any device performance data from a specific study.
• No Study Details: This document does not describe any specific study conducted to prove the device meets acceptance criteria. It doesn't mention sample sizes, data provenance, expert qualifications, ground truth methods, MRMC studies, standalone performance, or training set details.

To answer your questions, you would need access to the actual 510(k) summary or the original submission documents, which contain the technical details and performance data that the FDA reviewed.

Therefore, I cannot populate the table or answer the subsequent questions based on the provided text.

Ask a specific question about this device