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21.3-inch (54cm) Color LCD Monitor CDL2113A (CCL250i) (DV2MC-HB) 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.

CDL2113A (CCL250i) (DV2MC-HB) 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 document is a 510(k) summary for a medical display device, not an AI/ML device. Therefore, the requested information regarding acceptance criteria and studies proving the device meets those criteria, particularly within the context of AI/ML, is not fully applicable or present in this document.

However, based on the provided text, I can infer the general acceptance criterion for this device and the type of study conducted to establish its regulatory clearance:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not provided in the document. For a medical display monitor like this, the "test set" would typically refer to the various tests conducted on the hardware itself (e.g., luminance, chromaticity, uniformity, resolution tests conforming to industry standards like DICOM Part 14). The document only states that the device was compared to a predicate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided and is generally not applicable in the context of a medical display's 510(k) submission where "ground truth" would not be established by medical experts for image interpretation. Ground truth for a display typically relates to objective technical specifications measured by instruments.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided and is not applicable for a medical display device's review. Adjudication methods are relevant for studies involving human interpretation of medical images, often with AI.

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

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted image interpretation systems, not for a standalone medical display monitor.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, a standalone algorithm performance study was not done. This device is a display monitor, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The concept of "ground truth" as it applies to medical image content (e.g., presence of disease, lesion type) is not applicable to this device. For this display, the "ground truth" would be related to its technical specifications matching stated performance and quality metrics, typically measured by calibrated instruments and compared against industry standards, not against medical pathology or expert consensus on patient cases.

8. The sample size for the training set

This information is not applicable as this device is a hardware display monitor and does not involve AI/ML algorithms requiring a training set.

9. How the ground truth for the training set was established

This information is not applicable as this device is a hardware display monitor and does not involve AI/ML algorithms requiring a training set or associated ground truth establishment.

Summary of the Study that Proves the Device Meets the Acceptance Criteria:

The regulatory clearance for this device, K050616, was granted based on a substantial equivalence (SE) study rather than a clinical trial or performance study with medical experts. The core of the study involved comparing the new device, the CDL2113A (CCL250i) (DV2MC-HB) 21.3-inch Color LCD Monitor, to a previously cleared predicate device, the TOTOKU CDL2107A (K040697).

The study, as described in the 510(k) summary, aimed to demonstrate that the new device has "almost the same characteristics" as the predicate, with only minor differences identified (molds and a newly placed front sensor). While the document briefly mentions its technical specifications (DVI support, UXGA resolution) and intended use, the primary evidence for regulatory acceptance was the direct comparison to the predicate device, implying that since the predicate was deemed safe and effective for its intended use, a device with "almost the same characteristics" would also be safe and effective for the same intended use.

Specific technical tests (e.g., luminance, color accuracy, uniformity, resolution) would undoubtedly have been performed on the device to ensure it met general display standards for medical imaging, but the 510(k) summary focuses on the comparative aspect with the predicate as the basis for regulatory clearance. The FDA's letter confirms a "substantial equivalence determination."

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