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CX50N 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 LCD Monitor is intended to provide high resolution color and grayscale medical imaging for PACS and Radiology system. This Medical Monitor is intended to be used by trained medical practitioners for displaying, reviewing, and analysis of medical images.

EzCal ver.2 is a software solution which enables the user to modify display output to meet DICOM Part 14 GSDF and other key industry standards.

CX50N is being provided with the calibration software EzCal v.2 (developed by Qubyx Inc.) when requested by the customer.

The provided text is a 510(k) Summary for the WIDE Corporation CX50N LCD Monitor System. It describes the device, its intended use, and a comparison to a predicate device. However, it does not contain the detailed information needed to fill out all the specific sections of your request regarding acceptance criteria and the study proving the device meets them, particularly concerning AI or diagnostic performance studies.

The document focuses on the monitor's performance as a display device, not on an AI algorithm detecting medical conditions. The "acceptance criteria" discussed are related to display characteristics and compliance with electrical safety and electromagnetic compatibility standards, not diagnostic accuracy.

Here's a breakdown of what can and cannot be answered based on the provided text:

What can be extracted:

• 1. A table of acceptance criteria and the reported device performance: This is partially available for the monitor's display characteristics, but not for diagnostic performance.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Based on the text, no such study was performed for an algorithm. The device is a monitor.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable for a display device. The "ground truth" would relate to the display's ability to accurately represent images, not diagnose.
• 8. The sample size for the training set: Not applicable as there is no AI algorithm being trained.
• 9. How the ground truth for the training set was established: Not applicable.

What cannot be extracted from the provided text:

• 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): The document mentions "bench tests" for the monitor's performance but doesn't detail sample sizes or data provenance in the way one would for a diagnostic AI study.
• 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 for a display device clearance.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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 is a display monitor, not an AI-powered diagnostic tool.

Based on the provided document (K222719) for the CX50N LCD Monitor System:

The device under review is primarily an LCD Monitor System intended for displaying and viewing digital medical images, specifically for mammography and digital breast tomosynthesis applications. It is not an AI diagnostic algorithm. Therefore, many of the questions related to AI algorithm performance studies, expert ground truth establishment, and MRMC studies are not applicable to this device's clearance information.

The "acceptance criteria" and "study" described in the document relate to the physical and functional performance of the medical display monitor itself, ensuring it meets standards for image display quality and safety.

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

The document provides a comparison of technological characteristics between the subject device (CX50N) and its predicate device (K170783). While not explicitly labeled as "acceptance criteria," these are the performance metrics assessed. The "reported device performance" is essentially that the subject device's specifications are either the same or acceptable improvements/differences compared to the predicate.

Additional Bench Test Items (from Section 8):
The device was tested against instructions in 'Display Devices for Diagnostic Radiology - Guidance for Industry and Food and Drug Administration Staff, issued on October 2, 2017. Specific test items include:

• Pixel Defects
• Artifacts
• Luminance
• Reflection
• Luminance Uniformity
• Veiling Glare
• Color Uniformity
• Luminance Response
• Luminance at 30° and 45° in horizontal and vertical directions
• Temporal Performance Test
• Color Tracking
• Gray Tracking
• MTF (Modulation Transfer Function)

The document concludes that the "results of these tests demonstrate that CX50N meets the acceptance criteria and is adequate for this intended use."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states "The bench tests below were performed on the CX50N". It does not specify a "sample size" in the context of cases/patients, as this is a hardware device test. It likely refers to testing a specific number of manufactured units or prototypes of the CX50N monitor. Data provenance (country, retrospective/prospective) is not applicable here as it is about hardware testing, not clinical data collection.

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. The "ground truth" for a monitor is its specified technical performance characteristics and compliance with industry standards (e.g., DICOM Part 14 GSDF). These are measured instrumentally, not by human expert consensus on images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically used for establishing ground truth in diagnostic studies involving human interpretation, not for validating hardware performance.

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 device is a display monitor, not an AI diagnostic aid. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or is relevant for this clearance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in the sense that the monitor's performance was tested independently of human users' diagnostic abilities. However, this is not an "algorithm only" study as no diagnostic algorithm is part of this device cleared in this application. The standalone "performance" refers to the monitor's display characteristics.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance evaluation refers to established technical specifications and compliance with international and FDA-recognized consensus standards for medical displays (e.g., DICOM Part 14 GSDF, IEC 60601-1, IEC 60601-1-2) which are measured by instruments. It is not expert consensus, pathology, or outcomes data related to disease diagnosis.

8. The sample size for the training set
Not applicable. This device is a monitor and does not involve a training set for an AI algorithm.

9. How the ground truth for the training set was established
Not applicable. This device is a monitor and does not involve a training set for an AI algorithm.

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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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