(13 days)
RadiForce G33 is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The devices must not be used for digital mammography system.
RadiForce G33 is a 53cm (20.8") Color LCD display for medical viewing. G33 displays high-definition medical imaging.
The provided text is a 510(k) summary for a medical display device, the EIZO RadiForce G33, from 2005. It focuses on demonstrating substantial equivalence to a predicate device (EIZO FC-2091) rather than a clinical study evaluating diagnostic performance. Therefore, many of the requested elements for a study proving device performance are not present in the given document.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The concept of "acceptance criteria" for diagnostic performance, as might be found in a clinical study, is not directly applicable here. Instead, the "acceptance criteria" are implied by the comparison table to the predicate device, where the new device (G33) seeks to be substantially equivalent or improved in its technical specifications.
| Item | Acceptance Criteria (Predicate: FC-2091) | Reported Device Performance (G33) | Met? |
|---|---|---|---|
| Panel Size and Type | 53 cm (20.8") TFT monochrome LCD panel | 53 cm (20.8") TFT Monochrome LCD panel | Yes |
| Pixel Pitch | 0.207 mm x 0.207 mm | 0.207 x 0.207mm | Yes |
| Cabinet Color | Black | Black | Yes |
| Display Colors | 1,531 grayscale tones | 4,095 | Improved |
| Viewing Angles | H: 170°, V: 170° | H: 170°, V: 170° | Yes |
| Scanning Freq. (H, V) | 92.86 - 96.72Hz, 60Hz | 31-100kHz, 48-71.5Hz (VGA Text: 69-71Hz) Frame synchronous mode: 59-61Hz | Changed, presumed acceptable |
| Native Resolutions | 2048 x 1536 (landscape), 1536 x 2048 (portrait) | 2048 x 1536 (landscape), 1536 x 2048 (portrait) | Yes |
| Brightness | 650 cd/m² | 700 cd/m² | Improved |
| Contrast Ratio | 600 : 1 (typical) | 700 : 1 (typical) | Improved |
| DOT Clock | 132MHz | 165MHz | Improved |
| Response Time | 50 ms (typical) | 50 ms (typical) | Yes |
| Active Display Size (H x V) | 424 mm x 318 mm | 318x424mm | Similar (portrait/landscape swap) |
| Viewable Image Size | 529 mm (20.8") (diagonal) | 529 mm (20.8") (diagonal) | Yes |
| Luminance Calibration | Software (Optional), Photo-sensor (Optional), Protection panel (Optional) | Built-in swing calibration sensor provided. | Improved |
| Input Signals | DVI Standard 1.0 | DVI Standard 1.0 | Yes |
| Input Terminals | DVI-D 24 pin | DVU-D 24 pin | Yes |
| USB Ports / Standard | 1 upstream, 2 downstream / Rev. 1.1 | 1 upstream, 2 downstream | Similar |
| Power | 10V-120V/200V-240V, 50/60Hz, 0.7A-0.4A, 0.4-0.2A | AC100-120V, 200-240V, 50/60Hz | Similar |
| Power Management | DVI-DMPM | DVI-DMPM | Yes |
| Dimensions (W x H x D) | Varies by stand/no stand | Varies by stand/no stand | Similar |
| Certifications & Standards | TUV/GM, CE, CB, EN60601-1, UL2601-1, CSA C22.2 No. 601-1, FCC-A, Canadian ICES-003-A, VCCI-A | TUV/GM, CE Medical Device Directive, CB (EN60601-1), cTUVus (UL2601-1, CSA C22.2 No. 601-1), VCCI-B, FCC-B, Canadian ICES-003-A, CCC | Updated/Similar |
Note: The primary "study" presented is a comparison against a predicate device to establish substantial equivalence based on technical characteristics, not a clinical trial of diagnostic accuracy.
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. This submission describes hardware specifications and comparison to a predicate device, not a diagnostic performance study involving a test dataset of patient images.
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)
Not applicable. No ground truth establishment from experts for image interpretation is described, as this is not a diagnostic algorithm.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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
Not applicable. This device is a display monitor, not an AI-powered diagnostic tool. The document does not describe a MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a hardware device (monitor), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this device's performance relies on its technical specifications meeting or exceeding those of the predicate device, as verified by engineering measurements and compliance with standards.
8. The sample size for the training set
Not applicable. This is not a machine learning algorithm.
9. How the ground truth for the training set was established
Not applicable.
§ 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).