(45 days)
21.3-inch (54cm) Color LCD Monitor CDL2120A (CCL252i2) is to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is not meant to be used for digital mammography.
CDL2120A (CCL252i2) is a 21.3-inch Color LCD Monitor that supports DVI video signal and provides UXGA (1600 x 1200) resolution for both landscape and portrait display.
This 510(k) summary is for a medical display monitor and as such, it does not involve an AI/ML algorithm or a study comparing AI with human readers. The acceptance criteria for such a device typically relate to its technical specifications and performance characteristics, rather than diagnostic accuracy determined by a study involving a test set, ground truth, or expert readers as would be the case for an AI diagnostic tool.
Therefore, many of the requested sections (2, 3, 4, 5, 6, 7, 8, 9) are not applicable to the provided document.
Here's the relevant information that can be extracted:
Acceptance Criteria and Device Performance:
The document doesn't explicitly state "acceptance criteria" in the format of a table with specific thresholds. However, the core of the substantial equivalence claim for this monitor lies in its technical specifications being comparable to the predicate device. The performance is implied by these specifications.
1. A table of acceptance criteria and the reported device performance:
| Feature/Characteristic | Acceptance Criteria (Implied by equivalence to predicate) | Reported Device Performance (CDL2120A / CCL252i2) |
|---|---|---|
| Display Size | 21.3-inch (54cm) | 21.3-inch (54cm) |
| Display Type | Color LCD Monitor | Color LCD Monitor |
| Video Signal Support | DVI video signal | Supports DVI video signal |
| Resolution | UXGA (1600 x 1200) | UXGA (1600 x 1200) |
| Display Orientation | Landscape and portrait | Both landscape and portrait display |
| Intended Use | Displaying and viewing medical images for diagnosis by trained medical practitioners. Not for digital mammography. | Displaying and viewing medical images for diagnosis by trained medical practitioners. Not meant to be used for digital mammography. |
| Key Differentiating Feature from Predicate | Not applicable (predicate does not have this feature) | Newly-developed luminance equalizer |
Sections not applicable for this device and document:
- 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 monitor, not a diagnostic algorithm evaluated on a data set.
- 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.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 not an AI device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Summary of the Study/Basis for Substantial Equivalence:
The provided document indicates that the device, CDL2120A (CCL252i2), achieved substantial equivalence based on a comparison to a predicate device, CDL2113A ([K050616](https://510k.innolitics.com/search/K050616)). The "study" here is not a clinical trial with patient data, but rather a technical comparison and verification that the new monitor meets the necessary performance standards for its intended use and is functionally equivalent to a device already cleared for market. The only stated difference is the "newly-developed luminance equalizer," which implies that the technical performance of this equalizer, along with other core display characteristics, was evaluated against established industry and regulatory standards for medical displays, or demonstrated to not raise new questions of safety or effectiveness compared to the predicate.
§ 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).