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19-inch (48 cm) 1.3M Color LCD Monitor CDL1909A 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.

CDL1909A is a 19-inch (48cm) 1.3M 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.

The provided text describes a 510(k) premarket notification for a medical display monitor, the 19-inch (48 cm) 1.3M Color LCD Monitor CDL1909A. However, it does not contain the detailed acceptance criteria or the study data that typically proves a device meets such criteria for diagnostic performance of an AI or image-processing algorithm.

Instead, this document focuses on establishing substantial equivalence to a predicate device (CDL1904A, K051403) for regulatory clearance. The key information provided is about the device itself, its intended use, and the regulatory classification.

Therefore, most of the requested information cannot be extracted from the given text.

Here's what can be inferred or stated based on the provided text, and what cannot:

1. A table of acceptance criteria and the reported device performance

• Cannot be provided. The document does not define specific performance acceptance criteria for image quality or diagnostic accuracy in the way an AI or image processing algorithm would. As a display monitor, its "performance" is implicitly tied to its ability to accurately render images, which is typically assessed during manufacturing and quality control according to industry standards for medical displays, but not detailed here as specific acceptance criteria for a 510(k) submission in this format.

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/Cannot be provided. This document does not describe a performance study involving a test set of medical data for diagnostic purposes. It's a submission for a monitor, not an algorithm that interprets medical data.

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/Cannot be provided. No ground truth establishment activity is described for this monitor.

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

• Not applicable/Cannot be provided. No test set or adjudication process is described for this monitor.

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. This is a medical display monitor, not an AI or image processing algorithm intended to assist human readers. Therefore, an MRMC comparative effectiveness study involving AI assistance would not be part of its submission.

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

• No. This is a medical display monitor, not a standalone algorithm.

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

• Not applicable/Cannot be provided. No ground truth is mentioned or relevant to the regulatory submission for a display monitor.

8. The sample size for the training set

• Not applicable/Cannot be provided. This device is a monitor, not an AI algorithm requiring a training set.

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

• Not applicable/Cannot be provided. No training set or ground truth establishment is relevant to this device.

In summary: The provided 510(k) summary is for a medical display monitor and focuses on its substantial equivalence to a predicate device. It does not include information about diagnostic performance studies, AI algorithms, or the detailed acceptance criteria and study data typically associated with such criteria for an AI-powered diagnostic device. The "study" here is implicitly the demonstration of functional equivalence and adherence to relevant standards for medical displays (which are not explicitly detailed in this summary).

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