(104 days)
20.8 inch Monochrome Digital Mammography 3M pixel LCD Monitor with sub-pixel driving techniques enabling 9M subpixels to be driven independently, MS33i2 (ML21033) 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.
MS33i2 (ML21033) is a 20.8-inch monochrome LCD monitor whose display resolution is 1536 x 2048 (landscape), 2048 x 1536 (portrait) supporting DVI (digital visual interface) and DisplayPort.
This document is a 510(k) summary for a medical device called the "20.8 inch Monochrome Digital Mammography LCD Monitor MS33i2 (ML21033)" by TOTOKU ELECTRIC CO., LTD. It's a display monitor intended for viewing medical images for diagnosis, specifically in digital mammography PACS and modalities.
Based on the provided text, the device is a monitor, not an AI/algorithm-powered diagnostic tool. Therefore, the questions related to AI performance, sample sizes for training/test sets, ground truth establishment, expert adjudication, or MRMC studies are not applicable. The substantial equivalence is based on device characteristics rather than diagnostic performance.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a display monitor and not a diagnostic algorithm, typical performance metrics like sensitivity, specificity, or AUC as seen in AI studies are not relevant. The substantial equivalence is based on technical specifications and intended use comparison with a predicate device.
| Acceptance Criteria (Implied by substantial equivalence) | Reported Device Performance (Implied by substantial equivalence) |
|---|---|
| Intended Use: Used in displaying and viewing medical images for diagnosis by trained medical practitioners, in digital mammography PACS and modalities including FFDM. | Device shares the same intended use as the predicate device. |
| Technical Characteristics Comparison: Similar display resolution, monochrome display, DVI and DisplayPort support. | MS33i2 (ML21033) is a 20.8-inch monochrome LCD monitor with display resolution 1536 x 2048 (landscape), 2048 x 1536 (portrait). |
| Safety and Effectiveness: Demonstrated through comparison to a legally marketed predicate device. | Substantially equivalent to the predicate device MS31i2 (MDL2128A) (K090947). Differences are in the main board, LCD panel, and power supply, which are implicitly not considered critical enough to alter fundamental safety or effectiveness for the stated intended use. |
2. Sample size used for the test set and the data provenance
Not applicable. This is a medical device monitor, not a diagnostic algorithm that processes patient data. The evaluation for substantial equivalence would involve technical testing of the monitor's performance characteristics (e.g., luminance, contrast, resolution) rather than a test set of medical images with ground truth.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for diagnostic accuracy is not established for a monitor.
4. Adjudication method for the test set
Not applicable. Adjudication methods are used in studies involving diagnostic interpretations of images, which is not the primary evaluation 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. The device is a monitor, not an AI tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a monitor, not an algorithm.
7. The type of ground truth used
Not applicable. The concept of "ground truth" as it pertains to diagnostic accuracy studies is not relevant for a display monitor's regulatory clearance. The "ground truth" for a monitor would relate to its physical specifications and imaging performance standards.
8. The sample size for the training set
Not applicable. The device is a monitor, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. The device is a monitor, not a machine learning model.
§ 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).