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The CX50N(CX50YQS) LCD Monitor System is intended to be used in displaying and viewing digital medical images for review and analysis by trained medical practitioners. It is specifically designed for digital mammography applications and digital breast tomosynthesis applications.

CX50N(CX50YQS) is a flat panel hi-resolution LCD monitor system for displaying digital medical images. The system consists of a state-of-the-art LCD monitor and a high-resolution graphic control board that connects to a PACS workstation for color image display. The WIDE controller board is installed into the PACS workstation computer system to display PACS medical images.

The provided text describes the WIDE Corporation CX50N(CX50YQS) LCD Monitor System, which displays medical images for review and analysis, specifically for digital mammography and digital breast tomosynthesis. The document is a 510(k) summary indicating substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study conducted:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify a "test set" in the context of medical images or patient data. The testing described focuses on the monitor's technical specifications and compliance with international standards for electrical safety and electromagnetic compatibility. Therefore, there is no mention of data provenance (e.g., country of origin, retrospective/prospective) related to imaging data. The device itself (the monitor) underwent non-clinical testing.

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

Since this is a medical display device, not an AI-powered diagnostic tool, the concept of "ground truth" derived from expert interpretation of medical images does not apply in the context of the described testing. The 'ground truth' for the acceptance criteria would be the established technical standards and performance specifications for medical displays.

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

Not applicable, as there was no test set involving human interpretation of medical images.

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 medical monitor, not an AI-assisted diagnostic tool. No MRMC comparative effectiveness study was reported.

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

Not applicable. This device is an LCD monitor; it does not perform algorithmic analysis or have a standalone diagnostic function. Its performance is evaluated based on its ability to accurately display images.

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

For the safety and effectiveness testing of the monitor, the "ground truth" was established by international and FDA-recognized consensus standards (IEC 60601-1, IEC 60601-1-2) which define the technical performance requirements for medical electrical equipment and displays. The tests for resolution, luminance, contrast, and noise are objective measurements against these predefined technical specifications.

8. The sample size for the training set:

Not applicable. This device is a hardware monitor, not a machine learning algorithm that requires a training set.

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

Not applicable, as there was no training set.

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The CX50N(CX50YQS) LCD Monitor System is intended to be used in displaying and viewing digital medical images for review and analysis by trained medical practitioners. It is specifically designed for digital mammography applications.

CX50N(CX50YQS) is a flat panel hi-resolution(5MP) LCD monitor system for displaying digital medical images. The system consists of a state-of-the-art LCD monitor and a high-resolution graphic control board that connects to a PACS workstation for grayscale and color image display. The WIDE controller board is installed into the PACS workstation computer or other computer system to display PACS medical images.

Here's the breakdown of the acceptance criteria and study information for the CX50N(CX50YQS) LCD Monitor System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the individual tests (resolution, luminance, contrast, noise) "all met the acceptance criteria specified in the standards," but it does not explicitly list the numerical acceptance criteria from those standards. The reported device performance is that it "meets standards."

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

• Test Set Sample Size: Not applicable. This device is an LCD monitor system, and the non-clinical testing focused on physical performance characteristics against established standards, not on evaluating diagnostic accuracy using a dataset of medical images.
• Data Provenance: Not applicable for a traditional test set as described for AI/ML devices. The testing involved measurements of the monitor's physical characteristics and compliance with electrical and EMC standards.

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

• Not applicable. Ground truth, in the context of medical image interpretation, is not established for this type of device (a display monitor) in this submission. The "ground truth" for the non-clinical tests would be the established specifications and limits defined by the referenced international standards.

4. Adjudication Method for the Test Set

• Not applicable. There was no image interpretation test set requiring expert adjudication.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is an LCD monitor, not an AI-assisted diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not applicable. This is an LCD monitor system, not an algorithm. Performance testing was of the hardware itself against technical standards.

7. The Type of Ground Truth Used

• The "ground truth" for the non-clinical performance and safety tests was the established technical specifications and limits defined within the cited international and FDA-recognized consensus standards (e.g., IEC 60601-1, IEC 60601-1-2).

8. The Sample Size for the Training Set

• Not applicable. This device is an LCD monitor system and does not involve AI/ML requiring a training set.

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

• Not applicable. This device is an LCD monitor system and does not involve AI/ML requiring a training set.

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