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510(k) Data Aggregation
(42 days)
FUJIFILM UNITY SPEEDSUITE, MODEL CR-IR 371
FUJIFILM Unity SpeedSuite X-Ray System is Intended for 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, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
The FUJIFILM DR Unity SpeedSuite is a stand-alone X-ray exposure system comprised of a U- arm (manufactured by Sedecal) that incorporates the following: Fuji's image reader equipped with HD Linescan technology, Fuil's CR/DR Console (IIP), and Sedecal's X-ray source and U-Arm system (Verso). Since both are paired, the height and angle can be flexibly changed while maintaining their positional relationship. This system enables you to make an exposure not only at supine or upright position but also at any other desired positions. Images taken by the Unity system are sent to Fuii's IIP (CR/DR Console) to be processed. There is an automatic collimator made by Huestis attached to the tube head. The x-ray tube is manufactured by Toshiba
Here's an analysis of the provided text, focusing on the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided documents, the "acceptance criteria" for the FUJIFILM Unity SpeedSuite are primarily based on demonstrating substantial equivalence to a predicate device, the Sedecal URS LP X-Ray Units with Digital Detector (K042876). The "performance" is implicitly compared through a feature-by-feature assessment rather than explicit quantitative metrics of diagnostic accuracy.
| Characteristic | Acceptance Criteria (Predicate Device K042876) | Reported Device Performance (FUJIFILM Unity SpeedSuite) |
|---|---|---|
| Intended Use | General purpose diagnostic X-ray unit for skull, spinal column, chest, abdomen, extremities, and other body parts. | SAME - General purpose diagnostic X-ray unit for skull, spinal column, chest, abdomen, extremities, and other body parts; for adult and pediatric subjects; patient sitting, standing, or lying. |
| User Interface | Depends on Control Console option chosen. Mainly dedicated touch controls. | Software Driven Touch Panel LCD, + remote control unit + remote console. (Technological difference, but deemed equivalent in function) |
| Maximum Output | Depends on model of generator chosen. Models available from 30 kW to 64 kW. | Depends on model of generator chosen. Models available from Sedecal range from 30kW to 80 kW. (Technological difference, broader range, deemed equivalent) |
| Image Acquisition | Digital: CANON CXDI-50G. K031447. | Digital: Fuji Computed Radiography (FCR) Velocity K033561. (Technological difference in detector, but deemed equivalent) |
| Digital Panel Size | Up to 14" x 17" active area. | 17" x 17" active area. (Technological difference, larger size, deemed equivalent) |
| Digital Resolution | 160 micron pixels, with approximately 6 million pixels. | 100 micron pixels, 15 million pixels. (Technological difference, higher resolution, deemed equivalent or superior) |
| Method of Control | Dedicated push button Controls. | Software Driven Touch Panel LCD. (Technological difference, but deemed equivalent in function) |
| Collimator | Manual R302/A. | Automatic, Huestis 150PBL. (Technological difference, automation, deemed equivalent or superior) |
2. Sample Size Used for the Test Set and Data Provenance
The provided documentation does not mention a clinical test set with human patients or images for performance evaluation. The study focuses on demonstrating substantial equivalence through a comparison of technical specifications and the fact that the proposed device combines three already cleared devices.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. No clinical evaluation with expert ground truth establishment is described in these documents. The "ground truth" for this 510(k) submission is the technical specifications and cleared status of the predicate and component devices.
4. Adjudication Method
Not applicable. No clinical evaluation or expert review process requiring adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported in these documents. The submission focuses on substantial equivalence based on technical specifications and the combination of previously cleared components, not on human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
No, a standalone (algorithm only) performance study was not conducted or reported. The device is a hardware system for X-ray acquisition and processing, not an AI algorithm for image interpretation.
7. Type of Ground Truth Used
The "ground truth" implicitly used for this submission is regulatory clearance and established performance of predicate and component devices, along with technical specifications and bench/standards testing results of the proposed device itself. There is no mention of pathology, expert consensus on patient images, or outcomes data.
8. Sample Size for the Training Set
Not applicable. This device is a diagnostic X-ray system, not an AI image analysis algorithm that requires a training set of images.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, there is no AI algorithm requiring a training set for this device.
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