(58 days)
This Product is indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.
RadiForce MX317W is a color LCD monitor for viewing medical images other than those of mammography. The color panel employs in-plane switching (IPS) technology allowing wide viewing angles and the matrix size (or resolution) is 4,096 x 2,160 pixels (8MP) with a pixel pitch of 0.1674 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.
RadiCS is application software to be installed in each workstation offering worry-free quality control of diagnostic monitors including the RadiForce MX317W based on the OC 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 MX317W.
RadiCS is Basic Documentation level and that it's being used unchanged from the predicate software. RadiCS supports the functions of the monitor RadiForce MX317W and it's not a medical imaging software.
The provided text describes the RadiForce MX317W, a color LCD monitor for displaying radiological images. It is a Class II device (Product Code: PGY).
Here's an analysis of the acceptance criteria and the study performed, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a specific table of acceptance criteria with numerical targets and the device's numerical performance against those targets. Instead, it states that the device's characteristics "meet the pre-defined criteria when criteria are set" and that the test results showed "display characteristics equivalent to those of the predicate device, RadiForce MX315W."
However, it lists the types of performance tests conducted, which implies general acceptance criteria for these characteristics:
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Spatial resolution (Modulation Transfer Function - MTF) | Met pre-defined criteria; equivalent to predicate device. |
| Maximum number of pixel defects/faults | Met pre-defined criteria; equivalent to predicate device. |
| Absence of miscellaneous artifacts (based on TG18 guideline) | Met pre-defined criteria; equivalent to predicate device. |
| Temporal response | Met pre-defined criteria; equivalent to predicate device. |
| Luminance | Met pre-defined criteria; equivalent to predicate device. |
| Conformance to DICOM GSDF (based on TG18 guideline) | Met pre-defined criteria; equivalent to predicate device. |
| Color tracking | Met pre-defined criteria; equivalent to predicate device. |
2. Sample size used for the test set and the data provenance
The document describes bench testsperformed on the RadiForce MX317W. It does not mention a "test set" in the context of clinical data, images, or patient cases. Therefore, information about sample size for a test set and data provenance (country of origin, retrospective/prospective) is not applicable to this type of device and study. The testing was performed on the physical monitor itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The ground truth for the performance of a display device is established through technical measurements using specialized equipment and adherence to industry standards/guidelines (e.g., AAPM TG18), rather than expert consensus on medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as there was no clinical test set involving human interpretation of images. The performance was assessed through objective physical measurements.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is relevant for AI-powered diagnostic software, not for a display device like the RadiForce MX317W. The document explicitly states: "No animal or clinical testing was performed on the RadiForce MX317W."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The RadiForce MX317W is a display device, not an algorithm or AI system. Its performance is assessed as a standalone hardware unit for displaying images, not as an algorithm's standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the display characteristics (e.g., MTF, luminance, DICOM GSDF conformance) was established based on technical standards and guidelines, specifically "Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology" issued on September 28, 2022, and the "Assessment of Display Performance for Medical Imaging Systems by AAPM Task Group 18 (TG18 guideline)". This involves objective physical measurements against defined technical specifications.
8. The sample size for the training set
This information is not applicable. The RadiForce MX317W is a hardware display device and does not involve machine learning algorithms that require a "training set."
9. How the ground truth for the training set was established
This information is not applicable, as there was no training set.
§ 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).