(66 days)
21.3-inch (54cm) Monochrome LCD Monitor with sub-pixel driving techniques enabling 6M subpixels to be driven independently, MS21i2 (MDL2127A) is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is not meant to be used for digital mammography.
MS21i2 (MDL2127A) is a 21.3-inch (54 cm) Monochrome LCD monitor whose display resolution is 1200 x 4800 (landscape), 4800 x 1200 (portrait) supporting DVI (digital visual interface).
The provided text describes a 510(k) premarket notification for a medical display device, the TOTOKU ELECTRIC CO., LTD. 21.3-inch (54 cm) Monochrome LCD Monitor MS21i2 (MDL2127A).
This document focuses on regulatory approval based on "substantial equivalence" to predicate devices, rather than a detailed study evaluating the device's diagnostic performance against specific acceptance criteria. Therefore, most of the requested information (sample sizes, ground truth, expert qualifications, MRMC studies, standalone performance, etc.) is not available in the provided text, as it describes a display monitor and not an AI-powered diagnostic device.
Here's an attempt to answer the questions based on the available information and, where information is missing, to state that the information is not provided.
Device: TOTOKU ELECTRIC CO., LTD. 21.3-inch (54 cm) Monochrome LCD Monitor MS21i2 (MDL2127A)
1. A table of acceptance criteria and the reported device performance
For a medical display monitor like the MS21i2 (MDL2127A), acceptance criteria are typically related to display characteristics and regulatory compliance, ensuring it can accurately present medical images for diagnosis. The provided document does not explicitly list a table of performance criteria and results from a clinical study for this device, as it is a display monitor. The substantial equivalence argument implies that its performance is comparable to already-approved monitors.
Implicit Acceptance Criteria (inferred from device type and regulatory context):
| Acceptance Criteria Category | Specific Criteria (Inferred) | Reported Device Performance (Inferred from "Substantial Equivalence") |
|---|---|---|
| Purity and Uniformity | - Luminance uniformity across display |
- Color/grayscale uniformity | Satisfies industry standards for medical displays, comparable to predicate devices. |
| Resolution | - Display resolution of 1200 x 4800 (landscape) / 4800 x 1200 (portrait) | Achieves stated resolution (1200 x 4800 / 4800 x 1200). |
| Luminance & Contrast | - Maximum luminance - Minimum luminance
- Contrast ratio
- Compliance with DICOM Part 14 Grayscale Standard Display Function | Comparable to predicate devices, suitable for diagnostic image viewing. |
| Calibration Stability | - Long-term stability of display characteristics | Comparable to predicate devices. |
| Viewing Angle | - Acceptable image quality across typical viewing angles | Comparable to predicate devices. |
| Dead/Stuck Pixels | - Acceptable limits for pixel defects | Comparable to predicate devices. |
| Input Compatibility | - Supports DVI (digital visual interface) | Supports DVI. |
| Regulatory Compliance | - Meets FDA general controls - Electromagnetric compatibility (EMC)
- Electrical safety | Compliant with relevant standards, as per 510(k) clearance. |
Study to prove acceptance criteria: The 510(k) submission primarily relies on demonstrating substantial equivalence to predicate devices (ME253i2 (MDL2121A) (K063198) and MS51i2 (MDL2123A) (K081242)). For a display monitor, this typically involves technical comparisons and testing against recognized industry standards (e.g., DICOM Part 14, IEC standards for medical electrical equipment) rather than clinical studies with human readers or AI algorithms. The document explicitly states: "MS21i2 (MDL2127A) shares the same characteristics with our predicate devices, ME253i2 (MDL2121A) (K063198) and MS51i2 (MDL2123A) (K081242) except for bezel, enclosure and main board (driver board)." This indicates that the justification for meeting acceptance criteria is largely based on the established safety and performance of the predicate devices.
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 / Not Provided. This information would be relevant for a diagnostic algorithm or a clinical study. For a display monitor, validation focuses on technical specifications and substantial equivalence, not a "test set" of patient data.
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 / Not Provided. Ground truth establishment by experts is not described for a display monitor.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided. Adjudication methods are not described for a display monitor.
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 / Not Provided. This device is a display monitor, not an AI or CAD system. Therefore, an MRMC study comparing human readers with AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable / Not Provided. This device is a display monitor, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable / Not Provided. Ground truth, in the context of clinical accuracy for an AI/diagnostic device, is not defined for a display monitor. The "ground truth" for a display monitor's performance would be its conformity to technical specifications and industry standards.
8. The sample size for the training set
- Not Applicable / Not Provided. This device is a display monitor, not an AI system that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided. This device is a display monitor, not an AI system that requires a training set with established ground truth.
§ 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).