(28 days)
RadiForce GS310 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 GS310 is a 53cm (20.8") Monochrome LCD display for medical image viewing. GS310 displays high-definition medical imaging.
The provided text is a 510(k) summary for EIZO NANAO Corporation's RadiForce GS310 Monochrome LCD Monitor. This document is a premarket notification to the FDA, demonstrating that the new device is substantially equivalent to a legally marketed predicate device. As such, it does not contain a study section with detailed acceptance criteria and performance data in the way a clinical trial report would for an AI-powered diagnostic device.
Instead, the "study" demonstrating the device meets acceptance criteria is a comparison to a predicate device (EIZO NANAO RadiForce G33, K052337). The acceptance criterion is "substantial equivalence" to the predicate device in terms of technical characteristics and general functions, especially for displaying and viewing digital images for diagnosis.
Here's an breakdown of the requested information based on the provided text, with explicit notes where the information is not available due to the nature of a 510(k) for a display monitor:
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (a medical display monitor), the "acceptance criteria" are generally that its technical specifications meet or exceed those of a legally marketed predicate device and are suitable for the intended use. The performance is gauged by direct comparison to the predicate.
| Characteristic | Acceptance Criteria (based on predicate G33) | Reported GS310 Performance | Notes |
|---|---|---|---|
| Panel Size and Type | 53 cm (20.8") TFT Monochrome LCD panel | 53 cm (20.8") TFT Monochrome LCD panel | Substantially equivalent. |
| Pixel Pitch | 0.207 x 0.207mm | 0.207 x 0.207mm | Substantially equivalent. |
| Grayscale Tones | 4,096 from a pallet of 8,161 | 1,024 from a pallet of 8,161 | Difference noted: GS310 employs fewer grayscale tones. The summary states: "GS310 employs smaller grayscale tones than that of G33. The sole modification is 3 bit ratio in sub-pixel opening areas for GS310." The implication is that despite fewer tones, the device is still considered substantially equivalent for its intended use, likely through other improvements or the assertion that 1,024 tones are sufficient. This is a key point of comparison. |
| Viewing Angles | H: 170°, V: 170° | H: 170°, V: 170° | Substantially equivalent. |
| Native Resolutions | 1536 x 2048 (landscape/portrait) | 1536 x 2048 | Substantially equivalent. |
| Brightness | 700 cd/m² (Typical) | 700 cd/m² (Typical) | Substantially equivalent. |
| Contrast Ratio | 700: 1 (typical) | 900: 1 (typical) | Improvement noted: GS310 has a higher contrast ratio. This is a positive difference. |
| Luminance Calibration | Built-in swing calibration sensor provided | Built-in swing calibration sensor provided | Substantially equivalent. Others (e.g., certifications, input signals, physical dimensions) are also listed as substantially equivalent. |
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 (N/A) for a medical display monitor in this context. This 510(k) summary describes a hardware device (a monitor), not a software algorithm that processes medical data. The "test" for this device is primarily a comparison of its physical and technical specifications against a predicate device, rather than a performance study on a dataset of patient images. Therefore, there is no "test set" in the context of image data or patient cohorts.
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)
- N/A. Since there is no "test set" of medical images or patient data being processed, there were no experts establishing ground truth for such a set. The "ground truth" here is the established performance and safety of the predicate device and the technical standards for medical displays.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. No adjudication method for a test set of medical images was used.
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
- N/A. No MRMC study was performed. This device is a display monitor, not an AI-powered diagnostic tool, and therefore, it doesn't involve human readers "improving with AI assistance."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- N/A. This device is a monitor, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- N/A. For this device, the "ground truth" for substantial equivalence is the established performance and safety profile of the predicate device (RadiForce G33) and adherence to general performance standards for medical display monitors. This is not derived from patient outcomes, pathology, or expert consensus on a dataset of images.
8. The sample size for the training set
- N/A. There is no "training set" as this is a hardware device (monitor), not a machine learning algorithm.
9. How the ground truth for the training set was established
- N/A. As there is no training set, there is no ground truth established for it.
§ 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).