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20.8-inch (53cm) Color LCD Monitor CDL2119A (CCL352i2) 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.

CDL2119A (CCL352i2) is a 20.8-inch (53cm) 3 megapixel color LCD monitor that supports DVI video signal and provides UXGA (1536 x 2048) resolution for both landscape and portrait display.

The provided text describes a 510(k) summary for a medical display monitor, not a device that uses AI or processes medical images for diagnostic purposes. Therefore, most of the requested information regarding acceptance criteria and study design (especially related to AI, ground truth, expert adjudication, and sample sizes for training/test sets) is not applicable to this submission.

The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, which is typical for hardware components like monitors. The primary "performance" in this context relates to technical specifications ensuring suitable image display for medical diagnosis, rather than the accuracy of a diagnostic algorithm.

However, I can extract the relevant information that is available:

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

The document does not explicitly state "acceptance criteria" in the format of a clinical trial or performance study for an AI-powered device. For a medical display monitor, "performance" is generally assessed against technical specifications to ensure it meets the requirements for displaying medical images.

2. Sample size used for the test set and the data provenance

• Not Applicable. This is a medical monitor, not a device that processes or analyzes data. No "test set" of medical images was used in the context of an algorithm's performance evaluation.

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

• Not Applicable. See point 2.

4. Adjudication method for the test set

• Not Applicable. See point 2.

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 device is a display monitor, not an AI-assisted diagnostic tool.

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 an algorithm.

7. The type of ground truth used

• Not Applicable. See point 2.

8. The sample size for the training set

• Not Applicable. See point 2.

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

• Not Applicable. See point 2.

Summary of Device and Evidence:

The submission K072065 is for a 20.8-inch (53cm) 3M Color LCD Monitor CDL2119A (CCL352i2). Its intended use is for "displaying and viewing medical images for diagnosis by trained medical practitioners," explicitly excluding digital mammography.

The "study" or evidence provided for this type of device is primarily a comparison to a predicate device to establish substantial equivalence. The predicate device is identified as the "3M Color LCD Monitor CCL350i (CDL2112A) (DV3MC-HB) (K050619)."

The basis for substantial equivalence is that the new device "shares the same characteristics with our predicate device CCL350i (CDL2112A) (DV3MC-HB) (K050619) except for a LCD panel, power supply and (additional) fan." This implies that the manufacturer would have provided technical specifications and potentially conducted engineering tests to demonstrate that these new components do not alter the fundamental safety and effectiveness of displaying medical images compared to the predicate. The resolution (UXGA 1536x2048) and other display characteristics are key "performance" metrics for such a device, ensuring it can adequately present diagnostic images. No clinical performance study with human readers or AI algorithms is mentioned or expected for a medical display monitor in this context.

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