(24 days)
RadiForce RS110 is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. RadiForce RS110 does not support the display of mammography images for diagnosis.
RadiForce RS110 is a 48cm (19") Color LCD display for medical image viewing. RS110 displays high-definition medical imaging.
This document is a 510(k) summary for the EIZO RadiForce RS110 Color LCD Monitor. It outlines the device's characteristics and its substantial equivalence to a predicate device (RadiForce R12).
However, this document does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically described for a medical imaging algorithm or diagnostic device. This document describes a monitor, which is a display device, not a diagnostic algorithm. Therefore, many of the typical acceptance criteria and study parameters you asked for (like sample size, ground truth, expert adjudication, MRMC studies) are not applicable or detailed in this type of submission for a display monitor.
Instead, the "acceptance criteria" for a medical display device like this are primarily related to its technical specifications and performance characteristics, and the "study" proving it meets these involves technical measurements and comparisons to a predicate device.
Here's an interpretation based on the provided text, addressing your points where possible and noting where information is not available or not applicable:
1. Table of acceptance criteria and the reported device performance
For a medical display monitor like the RadiForce RS110, the "acceptance criteria" are implicitly its ability to meet or exceed the performance specifications of the predicate device (RadiForce R12) and comply with general medical display standards. The reported performance is highlighted by the comparison table itself.
| Acceptance Criteria (Implied: Match/Exceed Predicate) | Reported Device Performance (RadiForce RS110) |
|---|---|
| Panel Size and Type: 48cm (19") | Same as R12 (48cm (19")) |
| Pixel Pitch: 0.294 mm x 0.294 mm | Same as R12 (0.294 mm x 0.294 mm) |
| Display Colors: 16.77 million from 1.06 billion palette | Same as R12 (16.77 million from 1.06 billion palette) |
| Viewing Angles: H: 170°, V: 170° (Predicate) | Improved: H: 176°, V: 176° |
| Native Resolutions: 1280 x 1024 | Same as R12 (1280 x 1024) |
| Brightness: 270 cd/m² (Predicate) | Improved: 290 cd/m² |
| Contrast Ratio: 450 : 1 (typical) (Predicate) | Improved: 800 : 1 (typical) |
| Response Time: 20 ms (typical) (Predicate) | 25 ms (typical) |
| Input Terminals: DVI-D 29 pin x 2 (Predicate) | D-Sub mini 15pin, DVI-I 29pin (switchable) (Modified) |
| Power Consumption: 60 watts (typical) (Predicate) | Improved: 55 watts |
| Power Save Mode: Less than 8 watts (Predicate) | Improved: Less than 1.3 watts |
| Certifications & Standards: (Specifics listed for R12) | Updated and expanded list for RS110, including CE (Medical Device Directive), cTUVus (UL 60601-1, CSA C22.2 No. 601-1), VCCI-B, FCC-B, Canadian ICES-003-B, c-Tick, EPA ENERGY STAR®, EIZO Products 2009, RoHS |
| Intended Use: Displaying and viewing digital images for diagnosis of X-ray or MRI, etc., excluding mammography. | Identical for RS110. |
Study that proves the device meets the acceptance criteria:
The study is an equivalence demonstration by comparing the technical specifications of the new device (RS110) against a legally marketed predicate device (R12). The "study" is the detailed comparison table provided in Appendix 1, which shows that the RS110 either maintains or improves upon the performance characteristics of the R12, while maintaining the same intended use.
Specifically, the document states: "RadiForce R12 is substantially equivalent to RS110 employs the maximum resolution values same as that of R12. RS110 improved the brightness, contrast and viewing angle of the LCD module, and modified the calibration software." This forms the basis of their claim of equivalence and meeting (or exceeding) the implied acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable and therefore not provided in this 510(k) for a display monitor. There is no "test set" of medical images in the context of an algorithm's diagnostic performance. The testing here is of the monitor's physical and optical properties.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. Ground truth, expert consensus, and radiologists are relevant for evaluating diagnostic algorithms, not for the technical specifications of a display monitor. The "ground truth" for a monitor is its measured physical performance characteristics.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are used in diagnostic studies, not for the technical evaluation of a monitor's specifications.
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
This information is not applicable. MRMC studies are for evaluating the impact of a diagnostic tool (like AI) on reader performance. This document is for a display monitor, which is a passive viewing instrument.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is not an algorithm; it's a hardware display device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for a display monitor's performance is essentially the physical measurements of its technical specifications (brightness, contrast, viewing angles, resolution, power consumption, etc.) using calibrated equipment and standard test patterns. These measurements are then compared against the predicate device's specifications and relevant industry standards for medical displays.
8. The sample size for the training set
This information is not applicable. Training sets are used for machine learning algorithms. This device is a display monitor.
9. How the ground truth for the training set was established
This information is not applicable. As there is no training set for a display monitor, there's no ground truth for it to be established either.
§ 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).