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The CX30N(CX30PQX) LCD Monitor System is intended to be used in displaying and viewing digital medical images for review and analysis by trained medical practitioners. The display is not intended for mammography.

CX30N(CX30PQX) 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.

CX30N(CX30PQX) is being provided with the calibration software EzCal v.2 (developed by Qubyx Inc.) when requested by the customer.

CX30N is basic model and CX30PQX is identical to CX30N, except model name.

The provided text is a 510(k) summary for the CX30N (CX30PQX) medical display device. It describes the device's technical specifications, intended use, and a comparison with a predicate device to establish substantial equivalence. The document describes bench tests for performance, but it does not describe a study involving human readers, AI assistance, or the establishment of ground truth for diagnostic accuracy.

Therefore, many of the requested items (2-9) in the prompt cannot be answered from the provided text, as they pertain to clinical or standalone performance studies, which were not conducted or reported for this device based on the provided summary. The device in question is a medical monitor (hardware), not an AI algorithm or a diagnostic software.

Here's what can be extracted from the provided text regarding acceptance criteria and performance, as well as the limitations:

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

The document lists various "Test Items" that were performed, implying these are the parameters for which acceptance criteria would have been defined. However, the specific numerical acceptance criteria and the reported numerical performance values are not explicitly stated in the provided 510(k) summary. It only indicates that "CX30N(CX30PQX) meets the acceptance criteria."

Note: The phrase "meets the acceptance criteria" is a general statement. For a detailed understanding, the actual criteria (e.g., maximum allowable pixel defects, specific luminance range, etc.) and the measured values would be needed, which are not in this summary. The tests were performed "following the instructions in 'Display Devices for Diagnostic Radiology - Guidance for Industry and Food and Drug Administration Staff, issued on October 2, 2017.'" This guidance would contain the specific acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable as the described tests are bench tests of a physical display device, not clinical or image-based studies with patient data.

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

This information is not applicable for the reasons stated above. Ground truth, in this context, would relate to image interpretation, not display performance.

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

This information is not applicable for the reasons stated above.

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

An MRMC study was not performed as this device is a medical monitor, not an AI-powered diagnostic tool. The document explicitly states "No clinical studies were considered necessary and performed."

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

A standalone performance study was not performed beyond the physical bench tests for the display's technical specifications. This device is not an algorithm.

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

This information is not applicable for the reasons stated above. For the bench tests, the "ground truth" would be the engineering specifications and calibrated measurement tools for display performance.

8. The sample size for the training set

This information is not applicable. This document describes a medical display monitor, not a machine learning model.

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

This information is not applicable. This document describes a medical display monitor, not a machine learning model.

In summary, the provided document focuses on the technical specifications and bench testing of a medical display monitor to prove its substantial equivalence to a predicate device. It explicitly states that "No clinical studies were considered necessary and performed," indicating that the device approval did not hinge on human reader studies or AI performance metrics.

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The CX30N(CX30PQX) LCD Monitor System is intended to be used in displaying and viewing digital medical images for review and analysis by trained medical practitioners. The display is not intended for mammography.

CX30N(CX30PQX) 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 510(k) summary for the CX30N(CX30PQX) LCD Monitor System, which is a medical image display device. It is important to note that this document is for a medical monitor, not an AI/ML algorithm. Therefore, many of the typical acceptance criteria and study aspects related to AI/ML device performance (like MRMC studies, ground truth establishment for training/test sets, or expert consensus for labeling) are not applicable here.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the technical performance specifications of the monitor and the tests conducted to demonstrate that the monitor meets these specifications and relevant safety standards for its intended use as a medical display.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for a medical display like the CX30N(CX30PQX) are typically based on industry standards and performance specifications for medical imaging. The document highlights a comparison with a predicate device, which implicitly defines common performance expectations.

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

For a medical monitor, the "test set" does not refer to clinical image data in the same way it would for an AI/ML algorithm. Instead, the testing involves the device itself.

• Sample Size: The document implies that testing was conducted on the CX30N(CX30PQX) device as a unit. It doesn't specify a "sample size" in terms of multiple devices, typically performance testing like resolution, luminance, contrast, and noise are done on prototypes or production samples to ensure they meet specifications.
• Data Provenance: Not applicable in the context of clinical image data. The "data" here are the performance measurements of the monitor itself. The manufacturer is WIDE Corporation, located in the Republic of Korea. The testing would have been conducted by the manufacturer or accredited testing labs.

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

Not applicable. For a medical monitor, "ground truth" is established through physical measurement standards and calibration, not expert interpretation of images. The performance of the display is objectively measured against technical specifications and international standards (e.g., luminance, resolution). Human experts are the users of the display, not the ones establishing its ground truth.

4. Adjudication Method for the Test Set

Not applicable. This concept applies to the review of image data (e.g., for disease diagnosis) where there might be inter-reader variability. For a display device, performance measurements like brightness or resolution are objectively quantifiable and don't require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC study is a clinical study design used to evaluate the diagnostic performance of a medical imaging system or a CAD (Computer-Aided Detection)/AI device by assessing how human readers' diagnostic accuracy changes with and without the assistance of the device, across multiple cases. This is not applicable to a digital medical display itself, which is a display hardware, not a diagnostic aid.

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

Not applicable. The CX30N(CX30PQX) is a display device, not an algorithm. Its "performance" is its ability to accurately display images according to specifications, not to interpret or diagnose.

7. The Type of Ground Truth Used

The ground truth for this device (a medical monitor) is based on:

• Technical Specifications: Defined parameters like resolution (e.g., 2048x1536 pixels), pixel pitch, brightness (cd/m²), contrast ratio, and input signal compatibility.
• International Standards: Compliance with recognized safety and performance standards such as IEC 60601-1 (general safety) and IEC 60601-1-2 (electromagnetic compatibility).
• Measured Performance: Calibration and testing results (e.g., resolution, luminance, contrast, noise) demonstrating that the device meets these specifications and standards.

8. The Sample Size for the Training Set

Not applicable. This device is a hardware display and does not involve AI/ML algorithms that require a "training set" of data.

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

Not applicable. As explained above, there is no AI/ML training set for this device.

In summary, for the CX30N(CX30PQX) LCD Monitor System:

The acceptance criteria are primarily technical specifications and compliance with international safety and performance standards for medical displays. The study proving these criteria are met involves non-clinical bench testing to measure parameters like resolution, luminance, contrast, and noise, and to verify compliance with electrical safety and electromagnetic compatibility standards (IEC 60601-1 and IEC 60601-1-2). The document explicitly states that "No clinical studies were considered necessary and performed," which is typical for a device like a monitor where performance is assessed through engineering and physical measurements rather than clinical diagnostic accuracy studies.

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