(30 days)
RadiForce G22 is intended to be used in displaying for diagnosis in CT, DSA, or MRI, etc., except for a digital mammography system.
RadiForce G22 is a monitor for medical use. G22 provides 2 mega pixel (1200 x 1600) readly of or and 10 bit (1,024 tones) simultaneous grayscale display for accurate diagnosis in CT, DSA, and MRI, etc, except for a digital mammography system.
Device Acceptance Criteria and Performance Study: EIZO RadiForce G22 Monochrome LCD Monitor
This document describes the acceptance criteria and the supporting information for the EIZO RadiForce G22 Monochrome LCD Monitor, as presented in its 510(k) submission (K041597).
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the RadiForce G22 are implicitly defined by demonstrating substantial equivalence to the predicate device, the EIZO FC-2091 Monochrome LCD Monitor (K022109). The comparison focuses on key technological characteristics. The "Reported Device Performance" column reflects the specifications of the RadiForce G22.
| Characteristic | Acceptance Criteria (Predicate: FC-2091) | Reported Device Performance (RadiForce G22) |
|---|---|---|
| Panel Size and Type | 53 cm (20.8") TFT monochrome LCD panel | 19.6" Class Monochrome LCD Monitor |
| Pixel Pitch | 0.207 mm x 0.207 mm | 0.294 mm x 0.294 mm |
| Display Colors | 1.531 grayscale tones | 1,024 million grayscale tones from a pallet of 3,061 |
| Native Resolutions | 2048 mm x 1536 mm (landscape), 1536 mm x 2048 mm (portrait) | 1200 mm x 1600 mm |
| Brightness | 650 cd/m² | 800 cd/m² |
| Contrast Ratio | 600 : 1 (typical) | 600 : 1 (typical) |
| Response Time | 50 ms (typical) | 40 ms (typical) |
| Input Signals | DVI Standard 1.0 | DVI Standard 1.0 |
| Input Terminals | DVI-D 24 pin | DVI-D 24 pin |
| USB Ports / Standard | 1 upstream, 2 downstream / Rev. 1.1 | 1 upstream, 2 downstream / Rev. 2.0 |
| Luminance Calibration | Software (Optional), Photo-sensor (Optional) | Software (Optional), Photo-sensor (Optional) |
| Intended Use | Displaying for diagnosis in CT, DSA, and MRI, etc., except for a digital mammography system. | Displaying for diagnosis in CT, DSA, or MRI, etc., except for a digital mammography system. |
| Compliance Standards | TUV/GM, CE, CB, EN60601-1, UL2601-1, CSA C22.2 No. 601-1, FCC-A, Canadian ICES-003-A, VCCI-A, FDA 510(k) | TUV/GM, CE Medical Device Directive, CB (EN60601-1), cTUVus (UL2601-1, CSA C22.2 No. 601-1), FCC-B, Canadian ICES-003-A, VCCI-A, EIZO ECO Products 2002 |
Note: The differences in Pixel Pitch, Native Resolutions, Brightness, and Response Time for the G22 are considered to be within acceptable performance for the stated intended use and are not described as deviations requiring additional clinical testing. The updated compliance standards (e.g., CE Medical Device Directive) also reflect current requirements at the time of submission.
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary for the EIZO RadiForce G22 is for a monochrome LCD monitor, which is a hardware device. The equivalence is established through a technical comparison to a predicate device and compliance with relevant performance and safety standards.
- Sample Size for Test Set: Not applicable. For hardware devices like monitors, performance is typically evaluated through engineering tests, adherence to technical specifications, and compliance with industry standards, rather than a "test set" of patient data in the way an AI algorithm would be evaluated. The "test set" in this context refers to the monitor unit itself and its performance characteristics.
- Data Provenance: Not applicable in the context of clinical data. The data provenance would relate to the technical specifications and test results conducted by the manufacturer, which are assumed to be generated in Japan (country of origin for EIZO NANAO CORPORATION). The assessment is based on physical and electrical characteristics of the monitor.
- Retrospective or Prospective: Not applicable.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. As this is a hardware device (monitor), there is no "ground truth" derived from expert interpretation of medical images in the same way as an AI diagnostic algorithm. The "ground truth" for a monitor's performance is its technical specifications (e.g., brightness, contrast, resolution, grayscale tones) being met and verified through objective measurements and calibration, often against industry standards.
4. Adjudication Method for the Test Set
Not applicable. There is no expert adjudication of medical image interpretations as this is not an AI diagnostic device. The performance validation for a monitor involves engineering measurements and evaluations against established technical standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. An MRMC study is designed to assess the impact of a diagnostic aid (often AI) on human reader performance when interpreting medical cases. This device is a display monitor, not a diagnostic aid or AI algorithm.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a display monitor, not an algorithm. Its function is to accurately render images for human interpretation, not to make independent diagnoses.
7. Type of Ground Truth Used
The "ground truth" for the EIZO RadiForce G22 monitor is based on its technical specifications and performance characteristics. This includes:
- Objective Measurements: Brightness (cd/m²), Contrast Ratio, Pixel Pitch, Response Time, Native Resolutions, Grayscale Tones.
- Compliance with Standards: Adherence to international and national standards for medical display devices (e.g., DIN 6868-57, AAPM TG18, IEC 60601-1, FCC, CE Medical Device Directive, etc.), which ensure image quality, safety, and performance for medical use. The 510(k) mentions compliance with various standards (TUV/GM, CE, CB, EN60601-1, UL2601-1, CSA C22.2 No. 601-1, FCC-B, Canadian ICES-003-A, VCCI-A).
The comparison with the predicate device (FC-2091) serves as the basis for demonstrating substantial equivalence against an already cleared device with established "ground truth" performance for medical imaging display.
8. Sample Size for the Training Set
Not applicable. This is a hardware device (monitor), not an AI algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no AI algorithm and therefore no "training set," this question is not relevant.
§ 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).