(19 days)
RadiForce R31 and R31-C are intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. These devices must not be used for digital mammography system.
RadiForce R31 and R31-C are 53cm (20.8") Color LCD displays for medical viewing. Each model produces hi·crisp images for modality applications and 3D image fusion. The model difference between R31 and R31-C are the panel protector provided with R31-C and brightness only.
This 510(k) premarket notification (K052344) is for a medical display device, the EIZO NANAO CORPORATION’s Color LCD Monitor, RadiForce R31 and R31-C. It does not contain information about an AI/ML device or its performance study. Therefore, I cannot accurately answer your request.
Medical displays like the RadiForce R31 are evaluated based on display hardware performance specifications (e.g., luminance, resolution, contrast ratio, uniformity, color accuracy) and their ability to render medical images accurately, not on clinical performance metrics like diagnostic accuracy, sensitivity, or specificity that would be generated from a study involving image interpretation by human readers or an AI algorithm.
The provided documentation does not include:
- Acceptance criteria and reported device performance in terms of clinical outcomes or diagnostic accuracy.
- Sample sizes for test sets, data provenance, or ground truth establishment.
- Details about expert involvement, adjudication methods, or MRMC studies.
- Standalone algorithm performance or training set information.
Instead, the documentation focuses on the substantial equivalence of the new device to a predicate device (RadiForce R22) based on technical characteristics and intended use for displaying digital images for diagnosis.
§ 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).