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21.3-inch (54cm) Monochrome LCD Monitor MDL2122A 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.

MDL2122A is a 21.3-inch Monochrome LCD Monitor that supports both digital & analog video signals, and provides UXGA (1600 x 1200) resolution for both landscape and portrait display.

Here's an analysis of the provided 510(k) summary regarding the TOTOKU 21.3-inch (54cm) Monochrome LCD Monitor MDL2122A:

This 510(k) pertains to a medical display monitor, not an AI or diagnostic algorithm device. Therefore, many of the requested criteria such as sample size, expert ground truth, adjudication methods, multi-reader multi-case studies, and training set details are not applicable to this type of medical device submission. The substantial equivalence here is based on technical specifications and intended use compared to a predicate monitor.

1. Table of Acceptance Criteria and Reported Device Performance

For medical display monitors, acceptance criteria typically revolve around display characteristics meeting established standards for medical image viewing. The 510(k) summary implicitly relies on these standards being met to demonstrate substantial equivalence to the predicate device.

Note: The 510(k) summary does not provide specific performance metrics like luminance, contrast ratio, uniformity, or grayscale accuracy. Instead, it attests to the device's technical specifications matching those required for general medical image display and its substantial equivalence to a previously cleared device (MDL2121A, K063198).

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

• Not Applicable (N/A). This 510(k) is for a medical display monitor. It does not involve a 'test set' of medical images or patient data in the way an AI diagnostic device would. Substantial equivalence is determined by comparing the technical specifications and intended use of the new device against a legally marketed predicate device.

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

• Not Applicable (N/A). As above, there is no 'test set' requiring expert ground truth for a medical display monitor.

4. Adjudication method for the test set

• Not Applicable (N/A). No test set involved.

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 (N/A). This is a hardware display monitor, not an AI or diagnostic algorithm. MRMC studies are not relevant for this device type.

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

• Not Applicable (N/A). This is a display monitor. It does not have a standalone algorithm performance.

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

• Not Applicable (N/A). Ground truth is not a concept applied to the evaluation of a medical display monitor in this context. The "truth" for such a device is whether its technical specifications (resolution, luminance, uniformity, etc.) meet the necessary standards for displaying medical images for diagnosis.

8. The sample size for the training set

• Not Applicable (N/A). There is no training set for a medical display monitor.

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

• Not Applicable (N/A). No training set involved.

Summary of Device and Approval:

The TOTOKU 21.3-inch (54cm) Monochrome LCD Monitor MDL2122A received 510(k) clearance based on its substantial equivalence to a predicate device (MDL2121A, K063198). The key characteristics for this determination were:

• Device Type: 21.3-inch Monochrome LCD Monitor
• Resolution: UXGA (1600 x 1200)
• Signal Support: Digital & Analog video signals
• Display Orientation: Landscape and Portrait
• Intended Use: Displaying and viewing medical images for diagnosis by trained medical practitioners, excluding digital mammography.

The basis for proving it meets acceptance criteria is primarily through demonstrating that its technical specifications and intended use are consistent with a previously cleared device of the same type, and presumably, adheres to relevant industry standards for medical displays (though these standards are not explicitly detailed in the summary). The only difference mentioned from the predicate is the analog video signal.

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