(14 days)
The FC-2091 monochrome LCD monitor is intended to use in displaying for diagnosis of X-ray or MRI etc.
FC-2091 is 20.8 inches class monochrome LCD monitor for medical use. This monitor is usually used to display for X-ray diagnosis or MRI. such as one of the medical diagnosis system. This model has specification of resolution in 2048 × 1536 or 2048 × 1536 . And this model has the USB function and optional photo-sensor DTP92 made by X rite Incorporated. This model is certified IEC60601-1 for medical safety standard.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the EIZO FC-2091 monochrome LCD monitor:
Based on the provided 510(k) summary, the device is a medical display monitor. The submission is for a display monitor, not an AI-powered diagnostic device, so many of the requested fields related to AI performance, ground truth, and expert evaluation are not applicable. The primary "acceptance criteria" for such a device would relate to its technical specifications and demonstration of substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
For a medical display monitor like the FC-2091, the "acceptance criteria" are typically met by demonstrating technical specifications comparable to or better than a legally marketed predicate device, and compliance with relevant safety and performance standards. The study implicitly proving this is the technical comparison and demonstration of compliance found in the 510(k) submission.
| Acceptance Criteria (Implied from comparison with Predicate) | Reported Device Performance (FC-2091) |
|---|---|
| Resolution: Comparable to predicate. | 2048 x 1536 or 1536 x 2048 (Same as predicate ME311L) |
| Display Area: Comparable to predicate. | 423.9mm x 318mm (Same as predicate ME311L) |
| Gray-scale Display: Adequate for diagnostic imaging. | 1531 tones (10.5bit), in accordance with DICOM Part 14 (Superior to predicate ME311L's 1021 tones) |
| Luminance: Adequate for diagnostic imaging. | Max. 650[cd/m²] (Superior to predicate ME311L's 600[cd/m²] or more) |
| Luminance Calibration: Feature for calibration. | Software (Option), Photo-sensor (Option) [model DTP92:X-rite] (Comparable to predicate ME311L) |
| Safety Standards Compliance: Meeting medical safety. | IEC60601-1, UL2601-1, CSA No.601-1, MDD/CE (EN60601-1/EN60601-1-2), FCC class A, VCCI class A (Comparable to predicate ME311L) |
| Intended Use: Display for diagnosis of X-ray or MRI. | Intended to use in displaying for diagnosis of X-ray or MRI etc. (Identical to predicate's implicit intended use for a monitor) |
| Basic Structure: LCD display and stand, portrait mode. | Basic structure of LCD display and stand, capable of portrait mode. (Comparable to predicate ME311L) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable in the context of a diagnostic performance study. The "test set" here refers to the physical device undergoing technical evaluation against specifications. There isn't a "data set" of medical images being evaluated.
- Data Provenance: Not applicable. The evaluation is of the monitor's technical specifications and compliance with standards rather than its performance with patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. As this is hardware, ground truth is established through physical measurements, engineering specifications, and compliance with established standards, not through expert consensus on medical images.
4. Adjudication Method for the Test Set:
- Not applicable. There is no qualitative assessment by experts requiring adjudication.
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 is a medical display monitor, not an AI-powered diagnostic tool. There is no AI component.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a display monitor, not an algorithm.
7. The Type of Ground Truth Used:
- Technical Specifications and Compliance Documents: The "ground truth" for a medical display is its adherence to published technical specifications (e.g., resolution, luminance, grayscale tones) and compliance with international and national safety and performance standards (e.g., DICOM Part 14 for grayscale rendering, IEC 60601-1 for medical safety). This is demonstrated through engineering tests and documentation.
8. The Sample Size for the Training Set:
- Not applicable. This is a medical display monitor, not a machine learning model; therefore, there is no "training set."
9. How the Ground Truth for the Training Set was Established:
- Not applicable. There is no training set for a medical display monitor.
§ 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).