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This flat panel digital imaging system is intended for use in generating radiographic images of human anatomy. This device is intended to replace film/screen systems in all general purpose diagnostic procedures. This device is intended for use by qualified medical personnel. (Not for mammography)

This is a digital x-ray panel coupled with image acquisition software. The acquisition software is installed on a Windows compatible workstation. No routine user calibration or generator connection is required. AED and ACC are standard features. AED is automatic exposure detection. No synchronization connection to the generator is required. ACC is Automatic Calibration Control. Calibration values are automatically loaded at power-up. The TFT is inherently linear, and all that is necessary is to set a Start (Dark) and Stop (Bright) value to define the dynamic range you want to operate in. It is completely independent of the x-ray source. That is why this can be done at the factory. MECHANICAL: FITS IN THE BUCKY TRAY WITHOUT MODIFICATION... Ultra-Light Cassette Sized Detector easily moves from table top to wall to stretcher with ease. The system is compatible with CPI CMP 200 and Sedecal SHF series generators.

The provided document is a 510(k) summary for the Fusion Digital Diagnostic X-Ray Upgrade Kit (K141743). It explicitly states that "No new testing was done because no modifications have been made other than deleting the generator and tube stand" for both non-clinical and clinical tests (Sections 7 and 8 on page 4).

Therefore, this document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria for the K141743 submission.

The document refers to a previous clearance (K132294) for the "IDENTICAL digital x-ray panel/software/workstation." To obtain the requested information, one would need to review the 510(k) submission for K132294.

Based on the provided document K141743, the following questions cannot be answered:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

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