(500 days)
21.3 inch (54cm) Monochrome Digital Mammography 3M pixel LCD Monitor with subpixel driving techniques enabling 9M subpixels to be driven independently, MS3112 (MDL2128A) 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.
MS31i2 (MDL2128A) is a 21.3-inch (54 cm) monochrome LCD monitor whose display resolution is 1536 x 6144 (landscape), 6144 x 1536 (portrait) supporting DVI (digital visual interface).
This document focuses on the 510(k) summary for the TOTOKU MS31i2 (MDL2128A) monochrome digital mammography LCD monitor. This device is a display monitor and, as such, does not undergo the same type of performance studies (e.g., diagnostic accuracy studies with human readers, AI algorithms, and clinical outcomes) as a diagnostic imaging device or an AI-powered diagnostic algorithm.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context will refer to the technical specifications and standards that a medical display monitor must meet to be considered safe and effective for its intended use, particularly for mammography. The 510(k) summary provided here does not detail a clinical study with patients, readers, or AI algorithms; rather, it asserts substantial equivalence to predicate devices based on technical characteristics.
Therefore, many of the requested elements (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, training set details, ground truth for training set) are not applicable or not provided in the context of a 510(k) for a display monitor.
Here's an interpretation based on the provided document and general understanding of medical display regulatory submissions:
Acceptance Criteria and Device Performance for TOTOKU MS31i2 (MDL2128A)
This 510(k) summary for the TOTOKU MS31i2 (MDL2128A) monitor focuses on demonstrating substantial equivalence to predicate devices rather than detailing a specific clinical performance study with defined acceptance criteria for diagnostic accuracy. For a display monitor, acceptance criteria are typically related to its physical and performance specifications that ensure images are displayed accurately and consistently for medical diagnosis, especially in demanding fields like mammography.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided document, the acceptance criteria are implicitly tied to the performance characteristics being equivalent to the predicate devices and meeting relevant standards for display of medical images. Specific quantitative acceptance criteria are not detailed in this summary, but the device description highlights key specifications.
| Characteristic / Acceptance Criteria (Implied) | Reported Device Performance (from K096947) |
|---|---|
| Display Resolution | 1536 x 6144 (landscape) / 6144 x 1536 (portrait) |
| Screen Size | 21.3 inch (54 cm) |
| Display Type | Monochrome LCD |
| Sub-pixel Driving Technique | Enables 9M subpixels to be driven independently |
| Interface | Supports DVI (Digital Visual Interface) |
| Intended Use | Displaying and viewing medical images for diagnosis by trained medical practitioners in digital mammography PACS and modalities (including FFDM). |
| Equivalence to Predicate Devices | Shares the same characteristics with ME551i2 (K061447) and MS51i2 (K071794) |
Study to Prove Acceptance Criteria:
The "study" to prove the device meets acceptance criteria in this context is the substantiation of substantial equivalence to legally marketed predicate devices, ME551i2 (K061447) and MS51i2 (K071794). This involves demonstrating that the new device has the same intended use and similar technological characteristics, or that any differences do not raise new questions of safety and effectiveness.
For medical display monitors, this typically involves:
- Technical Bench Testing: Verifying that the monitor meets its published specifications (e.g., luminance, contrast ratio, uniformity, color stability for color displays, resolution, grayscale reproduction accuracy according to DICOM Part 14 standard).
- Compliance with Standards: Demonstrating adherence to relevant industry and regulatory standards for medical devices and displays (e.g., DICOM Part 14, IEC 60601-1 for electrical safety, IEC 60601-1-2 for electromagnetic compatibility).
- Comparison to Predicate Device Specifications: A direct comparison of the technical specifications of the new device against the predicate device to establish equivalence.
The 510(k) summary itself states: "MS31i2 (MDL2128A) shares the same characteristics with our predicate device ME551i2 (K061447) and MS51i2 (K071794)." This statement is the core of the "proof" from the regulatory perspective provided in this document.
Regarding the specific questions that are not directly applicable to a display monitor 510(k) from the provided text:
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 device is a display monitor, not a diagnostic algorithm or imaging system that processes patient data. The "test set" would refer to a set of technical tests on the display hardware itself, not a dataset of patient images.
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, in the sense of clinical diagnoses or pathology, is not established for a display monitor. Technical experts and engineers would evaluate the monitor's performance against technical specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. Adjudication is relevant for clinical studies where multiple readers interpret images.
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 device is a monitor, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a monitor, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not provided. The "ground truth" for a display monitor's performance would be objective measurements against technical standards (e.g., luminance measurements, spatial resolution charts, grayscale step tests), not clinical ground truth.
8. The sample size for the training set
- Not applicable. This device is a monitor, not a machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. This device is a monitor.
§ 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).