(44 days)
19-inch (48cm) Color LCD Monitor CDL1904A is to be used in conjunction with the picture archiving communication system (PACS) for medical imaging applications. It is not meant to be used for digital mammography.
CDL1904A is a 19-inch Color LCD Monitor that has a multi-scanning function corresponding to resolution from VGA 640 x 400 to SXGA 1280 x 1024. This is also compliant with VESA standard display mode.
This document is a 510(k) summary for the TOTOKU 19-inch (48cm) Color LCD Monitor CDL1904A. As such, it does not contain acceptance criteria or a study proving device performance in the way a clinical trial or performance study report for an AI/ML medical device would.
The information provided describes a medical monitor, which is a display device, not an AI algorithm or a diagnostic tool that provides performance metrics like sensitivity, specificity, or AUC. The concept of "acceptance criteria" for this device would relate to its technical specifications and conformity to industry standards for medical displays, not to its diagnostic performance.
Here's an analysis based on the provided text, addressing the points where applicable, and explaining why other points are not relevant:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the 510(k) summary. For a medical display monitor like the CDL1904A, acceptance criteria would typically involve technical specifications such as:
- Resolution: (e.g., SXGA 1280 x 1024 as stated in the device description)
- Luminance/Brightness: (e.g., cd/m²)
- Contrast Ratio:
- Color Accuracy:
- Viewing Angle:
- Uniformity:
- Pixel defect criteria:
- Compliance with medical display standards: (e.g., DICOM Part 14 Grayscale Standard Display Function, which is often a requirement for medical monochrome displays, though this is a color display).
The document states the device has "a multi-scanning function corresponding to resolution from VGA 640 x 400 to SXGA 1280 x 1024" and is "compliant with VESA standard display mode." This is a description of its capability, not a set of acceptance criteria or performance against those criteria.
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 is a display device, not an algorithm that processes data. There is no "test set" of medical images or data for performance evaluation in this context.
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. There is no ground truth, as this is a display device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no ground truth or test set for 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 device, not an AI algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a display device, not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. There is no ground truth, as this is a display device.
8. The sample size for the training set
Not applicable. This is a display device, not an AI algorithm.
9. How the ground truth for the training set was established
Not applicable. This is a display device, not an AI algorithm.
Summary from the provided document:
The 510(k) summary indicates that the TOTOKU CDL1904A is a 19-inch Color LCD Monitor intended for use with PACS for medical imaging applications, excluding digital mammography. The basis for its clearance is substantial equivalence to an existing predicate device, the ME183L (K030272). The substantial equivalence is claimed because the CDL1904A has "almost the same characteristics as TOTOKU's predicate device ME183L (K030272) except for the panel, molds and boards." This implies that the engineering and performance characteristics are comparable to a previously cleared device, satisfying regulatory requirements without needing a new clinical performance study for image interpretation.
§ 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).