(41 days)
20.8-inch (53cm) Monochrome LCD Monitor MDL2110A (ME351i) (DV3MM-HB) is to be used in conjunction with the picture archiving communication systems (PACS) for medical imaging applications. It is not meant to be used for digital mammography.
MDL2110A (ME351i) (DV3MM-HB) is a 20.8-inch Monochrome LCD monitor that supports DVI video signal and provides QXGA (2048 x 1536) resolution for both landscape and portrait display.
This 510(k) summary describes a monochrome LCD monitor, not an AI/ML device or a medical image analysis algorithm. Therefore, the detailed information requested regarding acceptance criteria, study design, ground truth, and human-in-the-loop performance is not applicable to this document.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (ME315L (K030274)) for regulatory clearance. The "device performance" in this context refers to the technical specifications of the monitor rather than diagnostic accuracy or effectiveness in analyzing medical images.
Here's an attempt to answer the relevant parts, noting the limitations:
1. Table of acceptance criteria and the reported device performance:
The document doesn't explicitly state "acceptance criteria" in the way one would for an AI/ML device's diagnostic performance (e.g., sensitivity, specificity thresholds). Instead, it implies acceptance based on similarity to the predicate device's technical specifications.
| Acceptance Criteria (Implied) | Reported Device Performance (MDL2110A) |
|---|---|
| Resolution | QXGA (2048 x 1536) |
| Display Type | Monochrome LCD |
| Screen Size | 20.8-inch (53cm) |
| Video Signal Support | DVI |
| Intended Use Consistency with Predicate | "used in conjunction with the picture archiving communication system (PACS) for medical imaging applications" (excluding digital mammography) |
| Characteristics "almost the same" as predicate (ME315L, K030274) | "almost the same characteristics as TOTOKU's predicate device ME315L (K030274) except for the molds, the AC adaptor, which has higher capacity and longer lifetime, and the front sensor, which has been newly placed." |
2. Sample size used for the test set and the data provenance:
Not applicable. This is a monitor, not a diagnostic algorithm evaluated on a dataset.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable.
7. The type of ground truth used:
Not applicable.
8. The sample size for the training set:
Not applicable.
9. How the ground truth for the training set was established:
Not applicable.
Summary of the Study (Implied from the 510(k) Summary):
The "study" or justification for clearance for this device centers on demonstrating substantial equivalence to an already legally marketed predicate device (TOTOKU ME315L, K030274).
- Study Type: Substantial Equivalence Comparison.
- Methodology: The manufacturer compared the technical specifications and intended use of the MDL2110A monitor to the predicate device ME315L.
- Key Finding: The MDL2110A has "almost the same characteristics" as the predicate, with minor changes (molds, AC adaptor, front sensor) that are not presented as impacting the fundamental safety or effectiveness for its intended use in medical imaging applications (excluding digital mammography).
- Acceptance: The FDA's letter (K050485) confirms that, based on this comparison, the device is substantially equivalent for the stated indications for use.
§ 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).