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21.3 inch (53 cm) Monochrome Digital Mammography LCD Monitor with additional sub-pixel driving techniques designed to improve image quality, MS51i2 (MDL2123A) is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is to be used in digital mammography PACS and modalities including FFDM.

MS51i2 (MDL2123A) is a 21.3-inch (53cm) monochrome LCD monitor whose display resolution is 2048 x 7680 (landscape), 7680 x 2048 (portrait) supporting DVI (digital visual interface).

The provided text is a 510(k) summary for a medical display device, not an AI/ML medical device. Therefore, the typical acceptance criteria and study designs associated with AI/ML devices (e.g., sample sizes for test and training sets, ground truth establishment, MRMC studies) are not applicable or described in this document.

The document describes a medical display monitor (TOTOKU MS51i2 (MDL2123A)) and its substantial equivalence to a predicate device for displaying and viewing medical images, specifically for digital mammography. The acceptance criteria for such a device primarily revolve around its technical performance specifications to ensure it can accurately display medical images for diagnostic purposes.

Since the document does not contain the detailed study information typically requested for AI/ML device evaluations, the following breakdown is based on what can be inferred or directly stated from the provided text regarding a display device's performance and validation.

Acceptance Criteria and Device Performance for TOTOKU MS51i2 (MDL2123A) - Medical Display Monitor

This section describes the acceptance criteria and a "study" in the context of demonstrating substantial equivalence for a medical display monitor, not an AI/ML diagnostic algorithm. The "study" here refers to the comparisons made to a predicate device and the technical specifications provided, rather than a clinical trial evaluating diagnostic accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

Given this is a display monitor, the "acceptance criteria" relate to its technical specifications and its ability to perform comparably to a predicate device. The document states "MS51i2 (MDL2123A) shares the same characteristics with our predicate device ME551i2 (K061447) except for a newly-developed Independent Sub-pixel Drive (ISD), AR (Anti-Reflection) special coating panel and firmware to display driver by FPGA." This implies that the device's performance meets or exceeds the predicate device's established performance without introducing new safety or effectiveness concerns.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable to this type of device submission. There is no "test set" of medical images in the context of an AI/ML algorithm. The performance of the monitor is assessed based on its technical specifications, manufacturing controls, and comparison to a predicate device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. Ground truth establishment for a test set of medical images is not relevant for a display monitor's 510(k) submission.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are used in studies involving human interpretation or AI/ML output, not for a display monitor's technical evaluation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is not relevant for a medical display monitor's 510(k) submission. These studies evaluate the diagnostic performance of human readers, sometimes with and without AI assistance. This document describes a passive display device.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

No. This is not an algorithm, but a display device. Standalone performance is not applicable.

7. The Type of Ground Truth Used

Not applicable for a display monitor. "Ground truth" for an image display would relate to the accuracy of its physical representation of image data, which is governed by technical standards, not expert labels on cases.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is not an AI/ML device that requires a training set.

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