(15 days)
ME511L (MDL2105A) is intended for use with the Picture Archiving Communication Systems (PACS) for medical imaging applications by physicians, including digital mammography.
ME511L (MDL2105A) is a 21.3-inch 5 megapixcel monochrome LCD display whose display resolution is 2560x2048 (QSXGA), supporting DVI (ditital visual interface).
The provided text is a 510(k) summary for the TOTOKU ELECTRIC CO., LTD. 5M Monochrome Digital Mammography LCD Monitor ME511L (MDL2105A). It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies against specific acceptance criteria. Therefore, much of the requested information regarding acceptance criteria and a detailed study proving the device meets them is not explicitly present in the provided document.
However, based on the context of a 510(k) for a medical display, we can infer some aspects and highlight where the information is missing.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria or a dedicated performance study against such criteria. The substantial equivalence argument implies that the device's performance is at least equivalent to the predicate.
| Acceptance Criteria (Inferred from equivalence to predicate) | Reported Device Performance (From 510(k) summary) |
|---|---|
| Maximum Resolution: Must be equivalent to predicate (Barco MGD 521M) for digital mammography. | Maximum Resolution: 2560x2048 (QSXGA) - "maximum resolution... are the same" as predicate. |
| Luminance: Must be equivalent to predicate (Barco MGD 521M) for digital mammography. | Luminance: "luminance are the same" as predicate. |
| Intended Use: Compatible with PACS for medical imaging applications, including digital mammography. | Intended Use: "intended for used with the Picture Archiving Communication Systems (PACS) for medical imaging applications by physicians, including digital mammography." |
| Display Technology: Suitable for professional medical display. | Display Technology: 21.3-inch 5 megapixcel monochrome LCD display. |
| Interface: Compatible with medical imaging systems. | Interface: Supports DVI (digital visual interface). |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the 510(k) summary. For a display device, a "test set" in the context of diagnostic accuracy studies (like those for AI algorithms) is not directly applicable. Performance testing for a display would typically involve objective measurements of display characteristics (resolution, luminance, contrast, uniformity, viewing angle, etc.) using calibration equipment and potentially visual assessments by trained personnel, rather than a "test set" of medical images with ground truth. The document only mentions that the device "employs a different display system" but that resolution and luminance are the same as the predicate.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided and is generally not relevant for the regulatory submission of a medical display like this. Ground truth establishment with experts is crucial for evaluating AI algorithms that interpret medical images, but not for a hardware display device whose primary function is to render images accurately.
4. Adjudication Method
This information is not provided and is not relevant for this type of device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not performed or reported in this 510(k) summary. MRMC studies are typically done for AI-powered diagnostic tools to assess how their use impacts human reader performance (e.g., diagnostic accuracy, reading time). This submission is for a display monitor.
6. Standalone Performance Study
A standalone performance study focused on diagnostic accuracy was not performed or reported in this 510(k) summary. The "performance" for a display is typically evaluated through technical specifications and adherence to standards (e.g., DICOM Part 14 for grayscale display function), not diagnostic accuracy in a clinical context. The claim of "substantial equivalence" is the primary "performance" argument in this document.
7. Type of Ground Truth Used
This information is not provided and is not relevant for this type of device. (See points 3 & 4).
8. Sample Size for the Training Set
This information is not provided. As this is a display monitor and not an AI algorithm, there would be no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is not relevant for this type of device. (See point 8).
Summary of Device Approval Context:
The 510(k) process for this device relies heavily on demonstrating substantial equivalence to a previously cleared predicate device (Barco MGD 521M Digital Mammography Display - K0338559). The core argument is that even though it uses a different display system, its key performance characteristics relevant to its intended use (maximum resolution and luminance) are the same as the predicate. The FDA's approval indicates that they found this argument of substantial equivalence sufficient, meaning the new device is as safe and effective as the predicate without requiring a new, extensive clinical performance study.
§ 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).