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The VERSIFLEX is intended to visualize anatomical structures by converting a pattern of x-radiation into an image through electronic amplification and recording, and, when used with injection of contrast medium, to visualize the heart or blood vessels.

The Hitachi VERSIFLEX is a new product. The VERSIFLEX is a multidirectional fluoroscopic/angiographic and radiographic system, incorporating a C-arm supporting base and an integrated patient tilting table into one system. With this system it is possible to carry out fluoroscopic/angiographic or radiographic examinations from various angles, and in combination with an X-ray generating unit and an image processing system, it can be used for multi-purpose examinations.

The provided document is a 510(k) summary for the Hitachi Versiflex, a fluoroscopy/angiography system. It asserts substantial equivalence to a predicate device and details the intended use and technological characteristics. However, it does not contain the specific information requested regarding acceptance criteria, device performance, study design, or ground truth establishment.

Therefore, I must state:

**The provided document does not contain the information required to complete the request regarding acceptance criteria and the study that proves the device meets those criteria. Specifically, the document is a 510(k) summary focused on substantial equivalence to a predicate device, and it does not include details on: **

• A table of acceptance criteria and reported device performance
• Sample sizes used for test sets
• Data provenance for test sets
• Number and qualifications of experts for ground truth establishment
• Adjudication methods
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study results or effect sizes
• Standalone algorithm performance
• Type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

The document only states that "The VERSIFLEX is being tested to UL-2601 and will not be marketed until the testing reaches a successful conclusion," which indicates safety testing, not performance criteria related to diagnostic accuracy or clinical effectiveness. The core of this 510(k) is a comparison of technological characteristics to a predicate device, not a performance study against specific acceptance criteria.

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