(59 days)
This product is intended for use in clinical radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.
RadiForce GX570 is a monochrome LCD monitor for viewing medical images including those of mammography. The monochrome panel employs in-plane switching (IPS) technology allowing wide viewing angles and the matrix size (or resolution) is 2,048 x 2,560 pixels (5MP) with a pixel pitch of 0.165 mm.
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. This helps ensure tone curves even if a display controller or workstation must be replaced or serviced.
The Digital Uniformity Equalizer function compensates luminance non-uniformity, one of the inherent characteristics of LCD panel modules, to the levels required by various QC standards and guidelines.
The Sharpness Recovery function compensates sharpness degradation caused by the inherent characteristics of LCD panel modules (A user selectable).
There are two model variations, GX570 and GX570-AR. The difference of the two variations is the surface treatment of the GX570 is Anti-Glare (AG) treatment and that of the GX570-AR is Anti-Reflection (AR) coating.
Two GX570 monitors mounted on a single stand configuration is available identified by with "MD" like GX570-MD and GX570-AR-MD.
RadiCS is application software to be installed in each workstation offering worry-free quality control of diagnostic monitors including the RadiForce GX570 based on the QC standards and guidelines and is capable of quantitative tests and visual tests defined by them. The RadiCS is included in this 510(k) submission as an accessory to the RadiForce GX570.
RadiCS is of Basic Documentation Level and that it's being used unchanged from the predicate software. RadiCS supports the functions of the monitor RadiForce GX570 and it's not a medical imaging software.
The provided FDA 510(k) clearance letter and summary are for a medical display monitor (RadiForce GX570), not an AI device or a diagnostic algorithm. Therefore, the information requested regarding acceptance criteria and a study proving an AI device meets those criteria cannot be extracted from this document.
The document discusses the technical performance of a display monitor, such as:
- Spatial resolution (MTF)
- Pixel defects
- Luminance and chromaticity (including DICOM GSDF conformance)
- Temporal response
- Noise (NPS)
- Display reflections
- Small-spot contrast ratio
These are physical and optical performance characteristics of a display hardware, not the diagnostic performance of a software algorithm.
Therefore, I cannot populate the requested table or answer the questions related to AI device performance, sample sizes for test/training sets, expert adjudication, MRMC studies, or ground truth establishment, as this information is not relevant to a medical display monitor clearance.
The document does state that the device is intended for use with "clinical radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners." However, the studies described are bench tests to assure the display hardware meets performance standards for displaying these images, not for interpreting them with AI.
§ 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).