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The uDR 592h, uDR596i Radiographic system is intended to use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, limbs and trunk .Not for mammography.

The uDR 592h, uDR 596i is a digital medical X-ray imaging system that the X-ray generated by the X-ray tube assembly is converted into digital signal through flat panel detector, finally image data using TCP/IP protocol transfers to image process software.

The software mainly has the following functions:

• A Patient Administration: supporting RIS and PACS system, register the emergency patient, dynamic real-time patient information search and display, support the display and ranking of examinations in different statuses;
• A Acquisition and post processing: selecting radiography protocol, display and adjust the exposure parameter, image acquisition and image display, provide image processing tools, such as zoom, pan, adjust window width/window level, delete all graphics, annotation and text, rotate, flip, gray invert, pixel lens, ROI zoom, cut, reload and reset;
• Image Transmission and Filming Function: image transmission to PACS server, A filming layout, filming preview, life-size filming, DVD burning function, image export and import function, supporting the USB device.

The uDR 592h, uDR 596i have been previously cleared by FDA via K181413. The modifications performed on the uDR 592h, uDR 596i (K181413) in this submission are due to the addition of an 80kW high voltage generator, x-ray tube and a new grid configuration (130 cm). Meanwhile, patient table and stitching stand have been optimized.

The modifications, which do not affect the intended use or alter the fundamental scientific technology of the device, are following:

• A Introduce a 80kW high voltage generator and X-ray tube
• Introduce a new grid configuration (focus: 130cm, grid line: 40L/cm, ratio: A 8:1)
• A Increase the maximum load weight of patient table and stitching stand.

This proposed device includes two models: uDR 592h, uDR 596i.The differences between the two models are as follows:

| Spec.
Model | HVG Power | Maximum Tube
Current | Remark |
|----------------|-----------|-------------------------|-------------------------------------------------|
| uDR 596i | 80kW | 1000 mA | New configuration in this
submission |
| uDR 596i | 65kW | 800 mA | Configuration in previous
submission K181413 |
| | 80kW | 1000 mA | New configuration in this submission |
| uDR 592h | 65kW | 800 mA | Configuration in previous
submission K181413 |
| | 50kW | 630 mA | Configuration in previous
submission K181413 |

The provided text is a 510(k) Summary for a medical device (uDR 592h, uDR 596i Radiographic system) and focuses on demonstrating substantial equivalence to a predicate device. It states that no clinical testing was conducted on the proposed devices. Therefore, the document does not contain information about acceptance criteria or a study proving the device meets those criteria for clinical performance measures.

The "Performance Data" section discusses "Non-Clinical Testing" and "Software," which refer to engineering and software validation tests rather than clinical efficacy or diagnostic accuracy.

Specifically, the document states:

• "Performance test for uDR 596i (80KW) and uDR 592h (80KW)" was conducted, adhering to various IEC and ES standards for medical electrical equipment, radiation protection, and X-ray equipment. The conclusion of these tests was that "the device performs as expected and thus, it is substantially equivalent to the predicate devices to which it has been compared."
• "Software Verification and Validation" was performed, confirming that "all the software specifications have met the acceptance criteria."

Without clinical testing, it's impossible to create a table of clinical acceptance criteria and reported device performance, or to provide details on sample sizes, ground truth, expert qualifications, or MRMC studies for diagnostic accuracy.

Therefore, the requested information regarding acceptance criteria and study details for clinical performance cannot be extracted from this document because no clinical testing was performed for this submission.

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