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The Wireless(V14 CLARITY, V14 HC, V17 CLARITY, V17 HC, F14 CLARITY, F14 HC)/Wired(V14 CLARITY, V14 HC, V17 CLARITY, V17 HC, F14 CLARITY, F14 HC, W17 Clarity, W17 HC) PRORAD X-Ray Flat Panel Detector with DROC is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications wherever conventional film/screen or CR systems may be used. The PRORAD X-Ray Flat Panel Detector with DROC is not intended for mammography, tomography, and angiography applications. The use of this product is not recommended for pregnant women and the risk of radioactivity must be evaluated by a physician.

PRORAD X-Ray Flat Panel Detector with DROC is the similar product to the predicate, Yushan X-Ray Flat Panel Detector with DROC, K201528, K210988, K220510. There are 8 models in this submission, V14 Clarity, V14 HC, V17 Clarity, V17 HC, W17 HC, F14 Clarity, F14 HC, W17 Clarity are a portable(wireless)/nonportable(wired) digital detector. The PRORAD X-Ray Flat Panel Detector with DROC is designed to be used in any environment that would typically use a radiographic cassette for examinations. Detectors can be placed in a wall bucky for upright exams, a table bucky for recumbent exams, or removed from the bucky for non-grid or free cassette exams. These medical devices have memory exposure mode, and extended image readout feature. Additionally, rounded-edge design for easy handling, image compression algorithm for faster image transfer, LED design for easy detector identification, extra protection against ingress of water.

The PRORAD X-Ray Flat Panel Detector with DROC sensor can automatically collects x-ray images from an x-ray source. It collects x-rays and digitizes the images for their transfer and display to a computer. The x-ray generator (an integral part of a complete x-ray system), is not part of the submission. The sensor includes a flat panel for x-ray acquisition and digitization and a computer (including proprietary processing software) for processing, annotating and storing x-ray images. The personal computer is not part of this submission.

PRORAD series is working by using DROC. This is a software running on a Windows PC as an user interface for radiologist to perform a general radiography exam. The function include:

1. Detector status update
2. Xray exposure workflow
3. Image viewer and measurement.
4. Post image process and DICOM file I/O
5. Image database: DROC support the necessary DICOM Services to allow a smooth integration into the clinical network

This submission for the PRORAD X-Ray Flat Panel Detector with DROC (K240771) indicates that no new performance data was generated to demonstrate substantial equivalence. Instead, the device is deemed substantially equivalent to its predicate devices (Yushan X-Ray Flat Panel Detector with DROC, K201528, K210988, K220510) due to minimal changes in product name, appearance, and labeling, implying that the performance of the device is identical to the predicates. Therefore, the acceptance criteria and study details would be those established for the predicate devices.

However, based solely on the provided document, which states "no clinical study has been performed" and that "the performance data is the same and need no extra validation," it explicitly does not include a study directly proving the device meets new acceptance criteria. It relies on the substantial equivalence argument, meaning the predicate devices' performance data is referenced implicitly.

Since the document explicitly states "No clinical study has been performed" and "Therefore the performance data is the same and need no extra validation", there isn't a direct study described in this document that proves the device meets (new) acceptance criteria. Instead, the device is deemed substantially equivalent to the predicate devices and thus relies on the predicate devices' performance data. The document does not provide details of any specific acceptance criteria or performance study results for the PRORAD device itself.

However, based on the non-clinical performance data section, it states that "the image quality evaluation confirmed that the image quality of the PRORAD X-Ray Flat Panel Detector with DROC is substantially equivalent to that of the predicate device." While this isn't a detailed study, it implies a comparison.

Here's an attempt to answer the questions based on the limited information regarding this specific device's performance, highlighting the reliance on predicate device information:

1. A table of acceptance criteria and the reported device performance

Based on the provided document, no specific acceptance criteria for the PRORAD X-Ray Flat Panel Detector with DROC itself are listed, nor is new device performance data reported. The document states that the device's technical characteristics, design, functional, and performance characteristics are similar to the predicate devices. The assumption is that the new device meets the same performance characteristics as the predicate. The comparison table of technical characteristics (from page 8-14 of the original document) contains performance-related metrics that are presented as identical or nearly identical between the subject device and the predicates.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states, "No clinical study has been performed." For non-clinical tests (e.g., electrical safety, EMC, mechanical, biocompatibility), sample sizes are not specified. The "image quality evaluation" also does not mention a sample size or data provenance. The assessment relies on the inherent similarity of the new device to the previously cleared predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as no new clinical study was performed for this 510(k) submission. The document relies on "image quality evaluation" that confirmed substantial equivalence, but details on experts or ground truth establishment for this comparison are not provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no new clinical study involving adjudication was performed for this 510(k) submission.

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

Not applicable. This device is a digital X-ray flat panel detector, not an AI-assisted diagnostic tool.

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

Not applicable. This device is an imaging hardware component, not an algorithm for standalone diagnostic performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable, as no new clinical study requiring ground truth was performed for this 510(k) submission. The "image quality evaluation" for substantial equivalence would likely rely on quantitative technical metrics rather than clinical ground truth for diagnostic accuracy.

8. The sample size for the training set

Not applicable, as no machine learning algorithm development (which would require a training set) is described for this device in the document.

9. How the ground truth for the training set was established

Not applicable, as no machine learning algorithm development is described.

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