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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:

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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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 system consists of Bucky Wall Stand, Tube Stand, Table, High-voltage Generator, X-ray Tube Assembly, Collimator, Flat Panel Detector, Power Distribute Unit, Control Console, Pluggable Grid, Ionization Chamber, Stitching Stand, Image Processing System and Monitor. The system software is a program used for patient administration, acquisition and post processing, image transmission and filming.

The system software provides functions such as import/export images, image viewing, image annotation, patient and study administration, store/delete/rec-over rejected images, exposure index monitoring, image documentation and achieving, automatic exposure control (AEC), stitching.

For automatic exposure control function, high voltage generator can terminate exposure automatically and the stitching provided in uDR 596i can stitch 2-4 single frame images into a full image.

Based on the provided text, here's a detailed breakdown of the acceptance criteria and the study information for the uDR 592h and uDR 596i devices:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria alongside reported device performance for a specific clinical endpoint. Instead, the "acceptance criteria" are implied by adherence to various electrical, safety, and performance standards, and the "reported device performance" is a general statement about meeting these standards and specifications.

However, a specific "Note 12" under "Comparison of Technological Characteristics" mentions acceptance criteria for the stitching function:

Other "performance data" are described in terms of conformance to various standards:

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "No Clinical Study is included in this submission."

Therefore, there is no information on a sample size for a clinical test set or its data provenance in the provided text. The only mention of "clinical images" for evaluation is in the context of the stitching feature and "sample clinical images evaluation" under performance verification, but no details on size or origin are given.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

For the specific "stitching feature" evaluation, it states: "The clinical images of stitching feature have been reviewed by a board-certified radiologist". This implies one expert.

The qualification provided is: "board-certified radiologist". No information on years of experience is given.

For any other "sample clinical images evaluation," no details regarding experts or their qualifications are provided.

4. Adjudication Method for the Test Set

There is no mention of a formal adjudication method (like 2+1 or 3+1) for any test set. For the stitching feature, it appears to be a single "board-certified radiologist" review, not a consensus or adjudication process.

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

No MRMC comparative effectiveness study was done as "No Clinical Study is included in this submission." The devices are referred to as "digital medical X-ray imaging system" and there is no indication of AI assistance in the available text.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

The device is described as a "digital medical X-ray imaging system," not an AI algorithm. Therefore, no standalone algorithm performance study would be relevant in this context. The "software" section details verification and validation of the software components as part of the system.

7. The Type of Ground Truth Used

For the stitching feature, the ground truth was based on expert opinion/consensus by a board-certified radiologist who "indicated that the provided images are of sufficient diagnostic quality."

For the broader "Performance Verification" and "Non-Clinical Testing," the ground truth is indirectly established by adherence to recognized international standards for electrical safety, EMC, radiation protection, and imaging performance parameters (e.g., dosimetry, image performance tests like DQE, MTF).

8. The Sample Size for the Training Set

The document states, "No Clinical Study is included in this submission." Therefore, there is no information on a training set or its sample size. The device is a traditional X-ray system, not an AI-driven image analysis tool requiring a training set in the typical sense.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned (since it's not an AI device relying on one), there is no information on how ground truth for a training set was established.

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