(63 days)
RadiForce MX241W is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The device is not specified for digital mammography system.
RadiForce MX241W is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. RadiForce MX241W does not support the display of mammography images for diagnosis.
RadiForce MX241W is 61cm Color LCD display for medical image viewing digital images viewing.
The provided text is for a 510(k) summary for a medical display monitor (EIZO RadiForce MX241W). This type of device is a display monitor, not an AI-powered diagnostic device, and therefore the kind of study and acceptance criteria you are asking for (e.g., related to algorithm performance, expert evaluations, MRMC studies, ground truth) are not applicable or typically part of the regulatory submission for such a display device.
The 510(k) submission for a medical display focuses on demonstrating substantial equivalence to a predicate device, primarily through comparison of technical specifications and intended use.
Here's a breakdown based on the information available and what is typically expected for this type of device:
1. A table of acceptance criteria and the reported device performance
For a medical display, acceptance criteria typically revolve around technical specifications such as brightness, contrast ratio, resolution, color accuracy, and compliance with industry standards (e.g., DICOM Part 14 for grayscale display function). The submission primarily highlights improvements over the predicate device.
| Acceptance Criteria (Implied / Compared to Predicate) | Reported Device Performance (RadiForce MX241W) |
|---|---|
| Panel Size (compared to predicate) | 61cm (24.1") |
| Brightness (compared to predicate) | 320 cd/m2 |
| Input Terminals (newly added) | DisplayPort |
| Intended Use | Displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners (not for digital mammography). |
| Classification | Class II (21 CFR 892.2050 - Medical displays) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a medical display device, not an image analysis or diagnostic software. Therefore, there is no "test set" of medical data in the context of diagnostic performance evaluation. The "testing" would involve electrical and optical performance measurements of the display itself.
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)
Not applicable, as there is no "ground truth" to establish for a display device in the same way there would be for a diagnostic algorithm. Performance is based on technical specifications and adherence to standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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 device is a display monitor, not an AI or CAD system, so an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is hardware (a monitor), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable.
8. The sample size for the training set
Not applicable.
9. How the ground truth for the training set was established
Not applicable.
§ 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).