(51 days)
21.3-inch (54cm) 3M Color LCD Monitor CCL354i2 (CDL2126A) is to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is not meant to be used in digital mammography.
CCL354i2 (CDL2126A) is a 21.3-inch (54cm) 3 meqapixcel Color LCD monitor that supports DVI video signal and provides UXGA (1536 x 2048) resolution for both landscape and portrait display.
This document describes the 510(k) summary for the TOTOKU ELECTRIC CO., LTD. 21.3-inch (54 cm) 3M Color LCD Monitor CCL354i2 (CDL2126A). This submission establishes substantial equivalence to a predicate device and does not detail a study proving the device meets specific acceptance criteria in the sense of a clinical performance study with defined metrics like sensitivity, specificity, or reader agreement.
The device is a medical image display monitor. For such devices, acceptance criteria typically relate to technical performance specifications (e.g., luminance, contrast, resolution, uniformity, color accuracy) rather than diagnostic performance in a clinical study. The provided text does not include a table of acceptance criteria or a study proving the device meets such criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device based on shared characteristics.
Therefore, many of the requested details, such as sample size for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth for training/test sets, are not applicable or not provided in this regulatory submission for a display monitor.
Here's a response based on the information provided in the input:
1. A table of acceptance criteria and the reported device performance
The provided 510(k) summary does not include a table of specific quantitative acceptance criteria (e.g., specific luminance levels, contrast ratios, or color accuracy metrics) or a study reporting the device's performance against such criteria. The submission primarily relies on demonstrating substantial equivalence to a predicate device.
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. This 510(k) summary for a medical monitor does not describe a clinical performance study with a test set of data/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. This 510(k) summary for a medical monitor does not describe a clinical performance study with ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This 510(k) summary for a medical monitor does not describe a clinical performance study 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 510(k) summary is for a medical display monitor, not an AI-powered diagnostic algorithm. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance was not conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a display monitor, not a diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. This 510(k) submission for a display monitor does not involve a clinical study requiring ground truth for diagnostic accuracy.
8. The sample size for the training set
Not applicable. This device is a display monitor and does not involve machine learning or a training set.
9. How the ground truth for the training set was established
Not applicable. This device is a display monitor and does not involve machine learning or a training set with ground truth.
Summary of Device and Evidence Presented in 510(k):
The 510(k) submission for the 21.3-inch (54 cm) 3M Color LCD Monitor CCL354i2 (CDL2126A) establishes substantial equivalence to its predicate device, the 3M Color LCD Monitor CDL2119A (CCL352i2) (K072065).
The basis for acceptance (regulatory clearance) is the demonstration of substantial equivalence. The argument for substantial equivalence is that the new device shares the "same characteristics" as the predicate device, with differences only in power supply, front bezel, frame, fan, PCB, and LCD screen. These differences are presumably not considered to affect the fundamental performance parameters relevant to its intended use for displaying and viewing medical images for diagnosis.
No specific quantitative acceptance criteria or detailed performance study results are provided in the excerpt. The regulatory submission relies on the established equivalence to a previously cleared device that meets the general controls and requirements for medical image display.
§ 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).