(15 days)
This product is intended to be used in displaying and viewing digital images including those of digital mammography for review and analysis by trained medical practitioners.
RadiForce RX850 is a color LCD monitor for viewing medical images including those of mammography. The color panel employs in-plane switching (IPS) technology allowing wide viewing angles. With the matrix size (or resolution) of 4.096 x 2.160 pixels (8MP), the RX850 is an alternate replacement for traditional dual head 5MP display installations. 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 RX850 based on the OC 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 RX850.
Here's an analysis of the provided text regarding the EIZO RadiForce RX850 monitor's acceptance criteria and studies:
Product: EIZO RadiForce RX850 8MP Color LCD Monitor
Study Reference: K140702 (510(k) Summary)
Acceptance Criteria and Reported Device Performance
The document does not explicitly list acceptance criteria in a quantitative table. Instead, it states that "the display characteristics of the RadiForce RX850 meet the pre-defined criteria when criteria are set" and that the "test results showed that the RadiForce RX850 has display characteristics equivalent to those of the predicate device, RadiForce RX840-MG except 2 items, each of which was determined that it would not affect observer's performance."
Based on the performance testing section, the acceptance criteria are implicitly tied to the performance metrics outlined by the AAPM Task Group 18 (TG18 guideline) and specific measurements related to display characteristics. The "reported device performance" is essentially that it met these implicit criteria and demonstrated equivalence to the predicate.
While quantitative acceptance criteria are not presented in a table with reported performance, the document lists various performance aspects that were tested. These can be inferred as the targets for acceptance.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Conformance to DICOM GSDF (as per TG18) | Met (The display characteristics meet the pre-defined criteria) |
| Acceptable angular dependency of luminance response (horizontal, vertical, diagonal) | Met (The display characteristics meet the pre-defined criteria) |
| Acceptable luminance non-uniformity characteristics (as specified in TG18) | Met (The display characteristics meet the pre-defined criteria) |
| Acceptable chromaticity non-uniformity characteristics (as specified in TG18) | Met (The display characteristics meet the pre-defined criteria) |
| Acceptable chromaticity at center of screen (5%, 50%, 95% max luminance) | Met (The display characteristics meet the pre-defined criteria) |
| Acceptable display reflections (specular, diffuse, haze) | Met (The display characteristics meet the pre-defined criteria) |
| Acceptable small-spot contrast ratio | Met (The display characteristics meet the pre-defined criteria) |
| Acceptable spatial resolution (MTF) | Met (The display characteristics meet the pre-defined criteria) |
| Acceptable noise (NPS) | Met (The display characteristics meet the pre-defined criteria) |
| Acceptable pixel aperture ratio | Met (The display characteristics meet the pre-defined criteria) |
| Absence of miscellaneous artifacts on the display screen (as specified in TG18) | Met (The display characteristics meet the pre-defined criteria) |
| Acceptable temporal response | Met (The display characteristics meet the pre-defined criteria) |
| Acceptable luminance stability | Met (The display characteristics meet the pre-defined criteria) |
| Maximum allowed pixel defects/faults | Met (The display characteristics meet the pre-defined criteria) |
| Equivalence to predicate device (RadiForce RX840-MG) for display characteristics functions | Demonstrated (except for 2 items determined not to affect observer performance, which are not specified in detail but imply other aspects were equivalent or superior, e.g., higher contrast, higher max luminance) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes bench tests performed on the RadiForce RX850 monitor. These tests assess the physical and photometric properties of the display device itself, not image data analysis from patients. Therefore, the concept of "test set" in terms of patient data or clinical cases is not applicable here. The "sample size" would refer to the number of RadiForce RX850 units tested, which is not specified but implicitly at least one unit.
The manufacturer, EIZO Corporation, is based in Japan, so the testing would have been conducted there or by their representatives. This is not a study involving patient data, so "retrospective or prospective" provenance is not relevant.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As this is a technical bench test of a display device, clinical "ground truth" established by medical experts is not relevant. The ground truth for these tests would be the measured physical properties of the display against established technical standards (like DICOM GSDF or TG18 guidelines). There is no mention of experts establishing a ground truth for a test set of images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no test set of clinical cases requiring adjudication. The performance is measured against technical specifications and guidelines.
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 submission is for a medical display monitor, not an AI-powered diagnostic algorithm. No MRMC study was performed or is relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a hardware monitor, not an algorithm. Standalone algorithm performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance testing is based on established technical guidelines and standards for medical displays. Specifically, the AAPM Task Group 18 (TG18 guideline) for display performance assessment and DICOM GSDF (Grayscale Standard Display Function) are mentioned as references. These are objective, quantifiable standards for display characteristics.
8. The sample size for the training set
Not applicable. This is a hardware monitor, not a machine learning model. There is no "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set for a machine learning model, the establishment of ground truth for such a set is not relevant.
§ 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).