(17 days)
The device is intended to be used as a tool in displaying and viewing digital images, including digital mammography system for view and analyses by trained medical practitioner.
The MMD-5201M LCD monitors are displays for medical use. MMD-5210M provides 5 mega pixel resolution and 766 grayscales per pixel display. The display device is complied with the standard ISO13406-2 to conform to the requirement of the mammography display system.
The provided text describes a 510(k) summary for the PACSmate MMD-5201M monitor. This document focuses on the regulatory clearance of a medical display device, not an AI or diagnostic algorithm, therefore, many of the requested criteria related to AI/algorithm performance and clinical studies are not applicable.
Here's an analysis of the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a numerical table form for performance. Instead, it indicates compliance with standards and equivalence to a predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Intended Use: Displaying and viewing digital images, including digital mammography for analysis by trained medical practitioners. | The performance test results demonstrated that the device meets its intended use specifications as a displayer for medical images. |
| Resolution | 5 Megapixel (up to 2560 x 2048 pixels) |
| Grayscales per pixel | 766 grayscales per pixel |
| Brightness | Maximum 850 cd/m2 |
| Contrast Ratio | 600:1 |
| Compliance with ISO 13406-2 standard (ergonomic requirements for flat panel displays) | The display device is complied with the standard ISO13406-2 to conform to the requirement of the mammography display system. The technical specification is compliance with the ISO 13406-2 standard: ergonomic requirements for flat panel displays ergonomics. |
| Substantial Equivalence to Predicate Device (EIZO RadiForce GS520) | Claimed to be substantially equivalent in terms of intended use, construction, function, safety, operating environmental conditions, and effectiveness. MMD-5201M employs the maximum resolution values same as that of RadiForce GS520. Performance testing demonstrated the device meets its intended use specifications and requirements. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The performance testing "demonstrated that the device meets its intended use specifications," but details about the methodology, sample size of images or cases tested, or data provenance are absent. As this is a display monitor, the "test set" would likely refer to images displayed on the monitor, but no specifics are given.
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)
This information is not provided and is largely not applicable for a medical display device. The device itself is not making a diagnostic judgment, so there is no "ground truth" in the sense of expert consensus on disease presence/absence to be established for the display's own performance. The document states the device is for "viewing and analyses by trained medical practitioner," implying the target user, but not for defining ground truth for the display's testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided and is not applicable for a medical display device. Adjudication methods are typically used in studies where human readers are interpreting images and their agreement is being assessed against a ground truth.
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
There is no indication that an MRMC comparative effectiveness study was done. This type of study is relevant for AI or CAD (Computer-Aided Detection/Diagnosis) systems, not for a passive display monitor. The device itself is a display, not an AI or CAD tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a display monitor, not an algorithm. Its function is to render images for human interpretation, not to provide an automated diagnostic output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This is not applicable for a medical display monitor in the context of its performance validation. The "ground truth" for a display would refer to the fidelity of the image presentation, adherence to display standards, and visual quality, not diagnostic accuracy based on pathology or outcomes.
8. The sample size for the training set
This is not applicable. The PACSmate MMD-5201M monitor is a hardware device. It does not utilize a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
This is not applicable for the same reason as point 8.
§ 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).