The indications for use of the FCR/DICOM Gateway Unit CR-DM666 is to serve as a gateway between a proprietary FCR DMS network and a standard ACR/NEMA Digital Imaging and Communications (DICOM) network.

Device Description

The device consists of a computer (console, display, keyboard, and mouse) and software. The device connects Fuji's proprietary Data Management System (DMS) medical image data networks complying with the American College of Radiology (ACR) and National Association of Electrical Manufacturers (NEMA) Digital Imaging and Communications in Medicine (DICOM) standard.

The Fuji network may contain Fuji Computed Radiography (FCR) image readers, workstations, optical disk files, multiformatters, and hard copy image printers. The multiformatters may receive image data from other modalities such as ultrasound, computed tomography (CT), and magnetic resonance imaging (MRI).

The FCR/DICOM Gateway Unit CR-DM666 is a DICOM CR-Storage Service Class (SCU) and DICOM SC-Storage Service Class device.

AI/ML Overview

This 510(k) summary describes a Fuji Computed Radiography FCR/DICOM Gateway Unit CR-DM666, which acts as a gateway between a proprietary FCR DMS network and a standard DICOM network. The key takeaway from the provided text is that no formal studies with specific acceptance criteria or performance metrics for image interpretation are presented. The submission primarily focuses on the device's technical characteristics, safety, and its equivalence to a predicate device in its role as a communication protocol converter for medical images.

Here's a breakdown based on your requested information, highlighting what is and is not present in the provided text:

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

Acceptance Criteria	Reported Device Performance
None explicitly stated for diagnostic accuracy or image quality. The submission focuses on functional and safety equivalence to a predicate device.	The device functions as a communications protocol converter, compliant with data communication controls for error detection and correction. It also complies with UL 1950 Standard for Safety.

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

Sample size for test set: Not applicable. No test set for evaluating diagnostic performance or image quality is mentioned.
Data provenance: Not applicable. The submission does not describe any studies involving medical image data for performance evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No test set for diagnostic performance or image quality is mentioned, and therefore no experts were used to establish ground truth in this context.

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

Not applicable. No test set for diagnostic performance or image quality is mentioned.

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, an MRMC comparative effectiveness study was not done. The device is a communications gateway, not an AI-assisted diagnostic tool. The submission emphasizes that "Images crossing the gateway are interpreted by a physician, providing ample opportunity for competent human intervention." This reinforces that the device is not designed to assist or replace human interpretation but rather to facilitate image transfer.

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

No, a standalone performance study was not done for diagnostic accuracy. The device's primary function is as a communication protocol converter. Its performance is related to its ability to transfer data reliably and safely, not to interpret images.

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

Not applicable. As no diagnostic performance study was conducted, there was no need for a ground truth.

8. The sample size for the training set

Not applicable. The device is a communication gateway and does not utilize a machine learning model that would require a training set.

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

Not applicable. As no training set is used, no ground truth for it was established.

Summary of the Device's "Study" and Acceptance Criteria:

The "study" described in this 510(k) summary is not an efficacy study in the sense of evaluating diagnostic performance. Instead, it's a demonstration of:

Functional Equivalence: The device performs the essential function of a DICOM gateway, similar to an existing predicate device.
Safety Compliance: The device complies with the UL 1950 Standard for Safety of Information Technology Equipment, Including Electrical Business Equipment.
Data Integrity: The device uses standard data communication controls to detect and correct errors during transmission.
Human Intervention: The manufacturer emphasizes that medical images are always interpreted by physicians, providing a safeguard against potential device failures related to image transfer.

The acceptance criteria, though not explicitly enumerated as such, are implicitly met by demonstrating these points of equivalence and safety. The entire submission is built on demonstrating substantial equivalence to a predicate device, rather than proving a specific clinical performance metric for image interpretation.

Summary

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MAR 2 1 1997

K970293

510(k) Summary [as required by 21 CFR 807.92]

Date Prepared [21 CFR 807.92(a)(1)]

January 13, 1997

Submitter's Information [21 CFR 807.92(a)(1)]

Fuji Medical Systems U.S.A., Inc. Post Office Box 120035 Stamford, Connecticut 06912-0035 Telephone: +1 203 973-2664 facsimile: +1 203 973-2777 Contact: Robert A. Uzenoff

Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]

The device trade name is Fuji Computed Radiography FCR/DICOM Gateway Unit CR-DM 666. The device common name is DICOM Gateway.

ﻨﻪ: Predicate Device [21 CFR 807.92(a)(3)]

Fuji views the subject device as an accessory to the predicate device, the Fuji FCR DMS Optical Disk Image Filing Unit OD-F6X4/L Series. FDA assigned the predicate to regulatory class II citing 21 CFR § 892.1750.

FDA's accession number for the premarket notification for the predicate device is K960326. FDA cleared the marketing of the predicate device in a letter dated March 7, 1996.

Description of the Device [21 CFR 807.92(a)(4)]

The FCR/DICOM Gateway Unit CR-DM666 is a DICOM CR-Storage Service Class (SCU) and DICOM SC-Storage Service Class device.

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FDA 510(k) Premarket Notification

Fuji Computed Radiography FCR/DICOM Gateway Unit CR-DM666

Intended Use [21 CFR 807.92(a)(5)]

Technological Characteristics [21 CFR 807.92(a)(6)]

There device does not contact the patient, nor does it control any life sustaining devices. Images crossing the gateway are interpreted by a physician, providing ample opportunity for competent human intervention.

The subject and predicate devices are both based on an industry-standard Sun SPARC Station with 64-bit micro-SPACR II microprocessor, standard 64MB RAM, and 1.5 GB fixed magnetic disk storage. Both use a CRT for character display as part of the user interface. No image data is displayed.

Unlike the predicate, the subject device may perform simple image processing: image rotation, reversal, and the decompression of reversibly compressed (ratio: ½) image data. No compressed image data is sent to the DICOM network.

Data loss may occur because of hardware failure (e.g. hard disk crash) or operator error (e.g. turning off power during hard disk access). However, unlike the predicate, as the device is not the data source, the gateway transmission can be completed after correcting the cause of the failure. Operation is password protected to prevent unauthorized use.

Performance Data [21 CFR 807.92(b)(1)]

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.

Conclusion [21 CFR 807.92(b)(3)]

As is the case with the predicate, the subject device have no patient contact. Nor do the subject device control, monitor, or effect any devices directly connected to or effecting a patient. The images relayed by the subject devices are observed by medical personnel, offering ample opportunity for competent human intervention in the event of a failure.

The device functions as a communications protocol converter, and not as a permanent image store. Device failures which might result in a failed transmission may be recovered from by retransmission after correcting the problem. Passwords are required for operation to protect against unauthorized use.

The subject and predicate share certification of conformance to the UL 1950 Standard for Safety of Information Technology Equipment, Including Electrical Business Equipment.

We conclude that the subject devices are as safe and effective as the predicate device.

Regulation Number and Section

N/A