(68 days)
The 21.3inch Monochrome LCD Monitor is intended to be used for displaying and viewing of digital images for diagnosis by trained physicians. The 21.3inch Monochrome LCD Monitor must not be used for primary diagnostic in mammography.
The monitor combines a TFT(thin film transistor) liquid crystal display panel structure and a built-in backlight with inverter for a better picture quality. The monitor can be used in portrait or landscape version, simply by turning the panel. The tilt and swivel foot allows ideal positioning of the panel, in height and viewing angle. The image brightness can be adjusted by means of a control wheel on the monitor. The LCD panel adopts Super Advanced-Super Fine TFT(SA-SFT) for the MD21GS-3MP-CB, BB and MD211GS3P-CB, BB. Additionally, a low reflection overooat is applied on top of the bead layer, which yields a low, uniform reflection over the surface of the glass. This process also provides for a truer representation of black and a higher contrast ratio. The MD21GS-3MP-CB, BB and MD211GS3P-CB, BB can select the use of the landscape or the portrait only by rotating the LCD panel. The tilt and swivel foot allows ideal positioning of the panel, in height and viewing angle. In addition, because our device has the height adjustment function of the stand, a more ideal positioning can be offered.
The provided text is a 510(k) Summary for a monochrome LCD monitor (NEC MD21GS-3MP-CB, NEC MD21GS-3MP-BB, MITSUBISHI MD211GS3P-CB, MITSUBISHI MD211GS3P-BB). This document aims to demonstrate "substantial equivalence" to a predicate device (Barco Coronis 3MP Medical Flat Panel Display System, K013922), not to conduct a study proving the device meets specific acceptance criteria in the context of a clinical performance study.
Therefore, many of the requested categories for acceptance criteria and study details cannot be directly extracted from this regulatory document. The document focuses on comparing technical specifications and intended use of the new device against a predicate device to establish that it is "substantially equivalent" for market approval.
Here's a breakdown of what can and cannot be provided based on the input:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (from predicate) | Reported Device Performance (New Device) |
|---|---|---|
| Intended Use | Displaying and viewing digital images for review by trained medical practitioners. | Displaying and viewing of digital images for diagnosis by trained physicians. (Exclusion: Not for primary diagnostic in mammography) |
| Resolution | Not explicitly stated for predicate, but new device aims for equivalence. | Can select 20481536 (landscape) or 15362048 (portrait modes). |
| Viewing Angle | 170° (Barco Coronis 3MP) | 176° (by adoption of SA-SFT panel) |
| Grayscale Reproduction | Not explicitly stated for predicate in number, but new device aims for equivalence. | Supports up to 1024 grayscales from a palette of 3061. 10-bit gamma correction. |
| Power Supply | Built-in circuit of power supply or AC adapter (described for predicate). | AC voltage converts to DC voltage within the device. |
| Safety Standard | UL60950 (Barco Coronis 3MP) | UL60601 (severer safety standard) |
| Panel Type | TFT liquid crystal display panel structure | Super Advanced-Super Fine TFT (SA-SFT) |
| Reflection | Not explicitly stated | Low reflection overcoat applied, low and uniform reflection. |
| Contrast Ratio | Not explicitly stated | Higher contrast ratio |
| Adjustability | Tilt and swivel foot | Tilt and swivel foot, plus height adjustment function. |
Missing Information/Not Applicable:
The document does not describe a clinical study with specific performance metrics like sensitivity, specificity, accuracy, or reader performance improvement. The "acceptance criteria" here are a comparison of technical specifications and intended use to an existing legally marketed device.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is a technical comparison for substantial equivalence for a medical display device, not a clinical study involving a test dataset of images or patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. Ground truth as typically understood in clinical studies (e.g., confirmed diagnoses) is not relevant for this type of regulatory submission concerning a display monitor.
4. Adjudication Method for the Test Set
Not applicable. No test set requiring adjudication in this context.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This document does not describe a clinical study comparing human reader performance with and without AI assistance. The device is a display monitor.
6. Standalone Performance Study
Not applicable. This document describes a display monitor, not an algorithm. Standalone performance (algorithm-only) would not be directly relevant for this device. The closest concept would be the technical performance of the monitor itself (resolution, brightness, grayscale), which is discussed via comparison to the predicate.
7. Type of Ground Truth Used
Not applicable in the clinical sense. For this device, "ground truth" would relate to measurable physical properties of the display (e.g., luminance, contrast, uniformity) and its adherence to relevant standards. The document implies these are met by virtue of design and comparison to the predicate, and by mentioning adherence to standards (e.g., 10-bit gamma correction).
8. Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 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).