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The indication for use of the FCR® Fuji Computed Radiography DMS CRT Image Console HI-C654 Multimodality Display System for Networks is to receive, process, display, and transmit medical images.

The subject device consists of a computer (system unit, display, keyboard, and mouse) and software. The subject device is a software modification of the predicate device. The modification may be to either existing or newly-installed predicate devices. One of two software modifications may be installed:
1? The network software adds network communication capability and newly permits lossy compression/decompression of approximately 5:1, 12:1, or 20:1. A "transmitter" network HI-C654 is connected directly to an image reader and can transmit images which optionally have undergone lossy compression to a network. A "receiver" network HI-C654 is connected only to the network and can receive images from the network. The transmitter/receiver status is indicated at power-on. Lossily compressed images are so labeled on the CRT display, along with a compression code which indicates the approximate compression rate.
2? The multimodality software a) includes the capabilities of the network software above, and b) adds the ability to receive images from multiformatters
3? The subject device connects either directly to one or two FCR® image readers, or to a proprietary network. The network may have on it FCR® image readers and Fuji multiformatters with image data from other imaging modalities such as CT, MR, DSA, NM, for example.
The device receives images from the FCR® image reader or network and stores, process, and displays the image. Stored images may be transmitted to other devices, such as multiformatters, archiving units, or other CRT image consoles.

The provided document is a 510(k) summary for the FCR® Fuji Computed Radiography DMS CRT Image Console HI-C654 Multimodality Display System for Networks. However, it does not contain information about specific acceptance criteria or a detailed study designed to prove the device meets those criteria.

The document largely focuses on demonstrating substantial equivalence to a predicate device (K931002) and describes the device's technological characteristics, particularly the addition of networking capabilities and optional lossy compression.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor details about a specific study proving it meets such criteria, as this information is not present in the provided text.

Here's a breakdown of what can be inferred or directly stated from the document regarding a "study" of the device, even though it's not a formal clinical performance study in the way implied by the request:

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

• Not Available: The document does not specify quantitative acceptance criteria (e.g., minimum diagnostic accuracy, image quality metrics) or report performance against such criteria. The device is primarily a display and transmission system, not a diagnostic algorithm that generates a "performance" metric in the typical sense of accuracy, sensitivity, or specificity.

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

• Not Applicable in this context: No "test set" of images or patient data is mentioned for evaluating diagnostic performance. The document focuses on regulatory compliance, hardware/software specifications, and safety. The "data" being handled by the device are medical images from various modalities, but there is no study evaluating diagnostic performance using a specific dataset.

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 there's no diagnostic performance study described, there's no mention of experts establishing ground truth for a test set. The document states that "Images displayed on the CRT image console are interpreted by a physician, providing ample opportunity for competent human intervention," which highlights the human-in-the-loop aspect of its intended use.

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

• Not Applicable: No test set or adjudication method is described.

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, not performed/reported: The document does not describe any MRMC study. This device is a display console, 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 a display console, not an algorithm providing a standalone diagnostic output. Its function is to "receive, process, display, and transmit medical images" for interpretation by a physician.

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

• Not Applicable: No ground truth is established for the device itself, as it is not a diagnostic device in the sense of making a medical judgment.

8. The sample size for the training set

• Not Applicable: The device is not described as involving machine learning or AI that would require a "training set" for diagnostic algorithm development.

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

• Not Applicable: As above, no training set or ground truth for such a set is mentioned.

What performance data is mentioned in the document:

The "Performance Data" section ([21 CFR 807.92(b)(1)]) in the document states:

• "The IEEE802.3 standard transceiver for Ethernet connection is employed."
• "The subject and predicate devices both use standard data communications controls to detect and correct errors."
• "The device complies with the UL 1950 Standard for Safety of Information Technology Equipment, Including Electrical Business Equipment."

These points refer to standard compliance and data integrity mechanisms, not diagnostic performance or image quality metrics. The "study" here is essentially compliance with engineering and safety standards, and a demonstration of substantial equivalence to the predicate device regarding its intended use and technological characteristics (handling images, displaying them, and transmitting them). The introduction of "lossy compression" is addressed by labeling the compressed images on the display, acknowledging the potential impact on image quality, and placing the ultimate interpretation responsibility on the physician.

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