(57 days)
5M Monochrome Digital Mammography LCD Monitor MDL2116A (ME551i2) is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is to be used in digital mammography PACS and modalities including FFDM.
MDL2116A (ME551i2) is a 21.3-inch 5 megapixel monochrome LCD monitor whose display resolution is 2048 x 2560 (QSXGA), supporting DVI (digital visual interface).
The provided text is related to a 510(k) submission for a medical device, specifically a "5M Monochrome Digital Mammography LCD Monitor MDL2116A (ME551i2)". This document, however, does not contain a detailed study design or acceptance criteria for a device that uses an algorithm or AI. Instead, it's a regulatory submission for a display monitor that practitioners use to view medical images, including those from digital mammography.
Therefore, many of the requested items, such as sample sizes for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and types of ground truth, are not applicable to this type of device. These are typically relevant for AI/ML-driven diagnostic devices or advanced image processing software that generate a clinical output, not for a display monitor.
The document primarily focuses on establishing substantial equivalence to a predicate device (ME511L (K0417337)) based on its technical specifications and intended use.
Here's an attempt to address the relevant points based on the provided text, and explicitly state where information is not available or not applicable:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria or performance metrics in a table format as would be expected for a diagnostic algorithm. The "reported device performance" for a monitor like this would typically involve technical specifications related to display quality, resolution, luminance, uniformity, and adherence to display standards for medical imaging (e.g., DICOM Part 14). While these are not detailed here, the statement of "Substantial Equivalence" implies that these performance aspects are at least comparable to the predicate device.
| Acceptance Criteria (Implied / Not Explicitly Stated for this Device Type) | Reported Device Performance (Implied from Substantial Equivalence and Device Description) |
|---|---|
| Display Resolution | 2048 x 2560 (QSXGA) |
| Display Type | 21.3-inch 5 megapixel monochrome LCD monitor |
| Connectivity | Supporting DVI (digital visual interface) |
| Intended Use | Displaying/viewing medical images for diagnosis, including digital mammography PACS and FFDM. |
| Substantial Equivalence to Predicate | Same characteristics as ME511L (K041737) except for board, power supply, and front sensor. |
2. Sample size used for the test set and the data provenance
Not Applicable. This is a hardware display monitor. There is no "test set" of medical images in the context of evaluating an algorithm's performance. The evaluation would involve technical testing of the monitor's display characteristics, not an analysis of a dataset of medical images.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable. As above, there is no "ground truth" establishment for a test set of medical images in the context of this device. The assessment is technical verification of monitor specifications and image display capabilities.
4. Adjudication method for the test set
Not Applicable. No test set of medical images 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 display monitor, not an AI or algorithm-driven diagnostic device. MRMC studies are used to evaluate the impact of a new diagnostic method (often involving AI) on human reader performance.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Not Applicable. This device is a display monitor and does not involve an algorithm or AI that operates in a standalone capacity.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not Applicable. No ground truth needed for a clinical study comparing an algorithm's performance. The "truth" for a monitor is its technical specifications meeting established display standards.
8. The sample size for the training set
Not Applicable. This is a hardware monitor; there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not Applicable. No training set exists 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).