(56 days)
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.
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.
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.
§ 892.2020 Medical image communications device.
(a)
Identification. A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, and interfaces. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions. This does not include electronic transfer of medical image software functions.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.