(189 days)
RadiForce RS210 is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. RadiForce RS210 does not support the display of mammography images for diagnosis.
Color LCD Monitor, RadiForce RS210
This document is an FDA 510(k) clearance letter for a medical display monitor, the Eizo RadiForce RS210. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria related to a diagnostic AI algorithm.
The letter simply states that the FDA has reviewed the manufacturer's premarket notification and determined that the device is substantially equivalent to legally marketed predicate devices. This means it has met the regulatory requirements for general controls, but there is no diagnostic algorithm being cleared or assessed for performance.
Therefore, I cannot provide the requested information, such as:
- A table of acceptance criteria and the reported device performance: This letter does not specify performance criteria for a diagnostic algorithm, as it is a monitor.
- Sample sized used for the test set and the data provenance: No diagnostic algorithm test set is described.
- Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable, as there's no diagnostic algorithm.
- Adjudication method: Not applicable.
- Multi reader multi case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (i.e. algorithm only without human-in-the-loop performance) study: Not applicable.
- ** Type of ground truth used:** Not applicable.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The "Indications for Use" section clearly states: "RadiForce RS210 is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. RadiForce RS210 does not support the display of mammography images for diagnosis." This confirms its role as a display device, not an AI diagnostic tool.
§ 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).