(28 days)
This Product is indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.
RadiForce MX194 is a color LCD monitor for viewing medical images other than those of mammography. The color panel employs Vertical Alignment (VA) technology allowing high contrast ratio and the matrix size (or resolution) is 1,280 x 1,024 pixels (1MP) with a pixel pitch of 0.294 mm.
Since factory calibrated display modes, each of which is characterized by a specific tone curve (including DICOM GSDF), a specific luminance range and a specific color temperature, are stored in lookup tables within the monitor, the tone curve is e.g. DICOM compliant regardless of the display controller used.
RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce MX194 based on the QC standards and guidelines and is capable of quantitative tests and visual tests defined by them. The RadiCS and its subset, RadiCS LE, are included in this 510(k) submission as an accessory to the RadiForce MX194.
The RadiForce MX194 is a color LCD monitor indicated for displaying radiological images for review, analysis, and diagnosis by trained medical practitioners, excluding mammography.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance (RadiForce MX194) |
|---|---|---|
| Spatial Resolution | Measurement of MTF (Modulation Transfer Function) | Equivalent to predicate device (RadiForce MX215) |
| Pixel Defects | Maximum number allowed for each type of pixel defects/faults | Met pre-defined criteria |
| Artifacts | Visual check of presence or absence of miscellaneous artifacts on the display screen as specified in TG18 guideline | Met pre-defined criteria |
| Temporal Response | Measurement of temporal response | Met pre-defined criteria |
| Luminance | Measurement of luminance | Met pre-defined criteria |
| DICOM GSDF Conformance | Verification of conformance to DICOM GSDF as specified in TG18 guideline | Met pre-defined criteria |
| Color Tracking | Measurement of color tracking | Met pre-defined criteria |
| Overall Display Characteristics | Display characteristics equivalent to the predicate device, RadiForce MX215 | Confirmed |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of clinical data for algorithmic performance. The performance testing described refers to bench tests conducted on the RadiForce MX194 device itself. Therefore, a specific sample size for a test set of medical images or data provenance is not applicable here as this is a display device, not an AI/ML algorithm that processes patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a display monitor, and the testing involved bench tests of its physical and performance characteristics, not an evaluation of diagnostic accuracy using a ground truth established by medical experts for image interpretation.
4. Adjudication method for the test set
Not applicable. This device is a display monitor, and the testing involved bench tests of its physical and performance characteristics, not an evaluation of diagnostic accuracy.
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 document describes a display monitor, not an AI-powered diagnostic tool. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a display monitor, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the performance testing of the RadiForce MX194, the "ground truth" was established by pre-defined criteria and industry guidelines such as the "Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology" (October 2, 2017) and the AAPM Task Group 18 (TG18 guideline). These guidelines specify objective measurements and visual criteria for evaluating display device performance. There was no medical ground truth based on patient outcomes or expert diagnoses, as this is a hardware device.
8. The sample size for the training set
Not applicable. This document is for a medical display device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This document is for a medical display device, not an AI/ML algorithm that requires a training set and corresponding ground truth.
Study Proving Device Meets Acceptance Criteria:
The study that proves the device meets the acceptance criteria is described under "7. Performance Testing" in the 510(k) summary.
Study Design:
The study was a series of bench tests performed on the RadiForce MX194. The tests followed the instructions outlined in the "Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology" (issued October 2, 2017) and the "Assessment of Display Performance for Medical Imaging Systems by AAPM Task Group 18 (TG18 guideline)".
Tests Performed:
The following specific tests were conducted:
- Measurement of spatial resolution expressed as modulation transfer function (MTF)
- Evaluation of pixel defects/faults (maximum number allowed for each type)
- Visual check for the presence or absence of miscellaneous artifacts on the display screen as specified in the TG18 guideline
- Measurement of temporal response
- Measurement of Luminance
- Verification of conformance to DICOM GSDF as specified in the TG18 guideline
- Measurement of Color tracking
Results:
The test results demonstrated that:
- The RadiForce MX194 has display characteristics equivalent to those of its predicate device, RadiForce MX215.
- The display characteristics of the RadiForce MX194 meet the pre-defined criteria established as acceptance criteria for each test.
Conclusion of the Study:
The performance testing concluded that the RadiForce MX194 is substantially equivalent to the predicate device (RadiForce MX215) and meets all pre-defined performance criteria, confirming its safety and effectiveness for its intended use. No animal or clinical testing was performed for this device.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).