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The RadiForce Large Monitor System is intended to be used by health care professionals to integrate the video output from various commercially-available instruments commonly used in a medical procedure laboratory into a single video display.

The system consists of the following components:

• LS560W Large Monitor Model No. 6GF6200-8A$## mandatory component
• LMM56800 Large Monitor Manager Model No. 6GF6020-1A$## mandatory component
• PDC0100 Analog DVI Converter -- Model No. 6GF6010-0B$## -- optional accessory
• PDS0800 DV! Splitter/Scaler Model No. 6GF6020-0AA00-#$$# optional accessory
• TDL3600 Transmission Link Model No. 6GF6010-#$$## optional accessory
• CID1000P Control Interface Device 6GF6550-2H$## optional accessory
• Cabinet optional accessory

where "$" signifies a letter from A to Z, and "#" a number from 0 to 9.

The RadiForce Large Monitor System is a large color flat panel monitor for viewing images derived from several video sources on a single display and to rearrange these images to the situational requirements of the user. To appreciate all of the advantages of the large widescreen monitor, the data has to be collected from the various sources and prepared for variable viewing. This is handled by the mandatory "Large Monitor Manager" ("LMM"). In some reports or references you will find the "LMM" being called "MDM" for "Multi Display Manager" (customer specific product name). The various video sources are being bundled using the Large Monitor Manager and from there being fed into the Large Display via two DVI lines.

Control of the video sources can also be accomplished using Eizo's Control Interface Device CID as optional part of the system or any other standard browser compatible operator console.

The RadiForce Large Monitor System uses a color LCD panel employing Multi-domain Vertical Alignment (MVA) technology to allow wide viewing angles. It has a resolution of 3840 x 2160 pixels and is used in landscape mode.

The various video sources from medical and other devices are being collected using the Large Monitor Manager and from there being fed into the Large Display via two DVI lines. An optional external operator console (Control Interface Device CID) can be used as optional part of the system to rearrange pictures from the regarding sources or switch between numerous presets according to specific user's needs.

The RadiForce Large Monitor System may be offered in different housing colors and with different logos. These are cosmetic differences and of no effect on the function and performance of the system.

The provided text describes the EIZO RadiForce Large Monitor System, but it does not contain details about specific acceptance criteria or a study designed to prove the device meets such criteria in terms of clinical performance or diagnostic accuracy.

The document focuses on:

• Device Description and Intended Use: A large color flat panel monitor system for integrating and displaying video from various medical instruments.
• Technological Characteristics: Resolution, panel technology, and how it handles multiple video sources.
• Performance Testing (Compliance): Verification that the system complies with certain standards (NEMA DICOM, IEC, UL, FCC) for electrical safety and electromagnetic compatibility.
• Substantial Equivalence: A claim that the device is substantially equivalent to a predicate device (Cardio-View, K083321) regarding technical characteristics, application, and intended use, and that differences do not affect safety or effectiveness.

Therefore, many of the requested sections about acceptance criteria, clinical study details, sample sizes, ground truth, and expert involvement cannot be extracted.

Here's a breakdown of what can be inferred from the text based on the provided categories:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable. The document describes engineering/compliance testing of a display device, not a clinical study involving a "test set" of patient data. The "test set" in this context would refer to internal company "system and performance tests" without specifying sample sizes or data provenance.

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

• Not Applicable. This information is not provided because the testing described is not related to establishing clinical ground truth for diagnostic accuracy.

4. Adjudication method for the test set

• Not Applicable. This information is not provided.

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. No MRMC or human-in-the-loop study is mentioned. This device is a display monitor, not an AI diagnostic algorithm.

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

• Not Applicable. This device is a display monitor, not an algorithm.

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

• For the DICOM compliance test, the "ground truth" is the ideal curve represented by the Barten model.
• For safety and EMC tests, the "ground truth" is compliance with the specified international standards (IEC, UL, FCC).
• For system functionality, the "ground truth" is the device's own specifications.

8. The sample size for the training set

• Not Applicable. This device does not use a "training set" in the context of machine learning.

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

• Not Applicable. This device does not have a "training set."

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The 10MP Grayscale Flat Panel Display (GX1030) is intended to be used in displaying and viewing digital images, including digital mammography, for review and analysis by trained medical practitioners.

The 6GF6201-8CS## is a diagnostic 10MP gravscale flat panel display for viewing medical images. With the callbrated gamma response stored in five internal lookup tables, the display is suitable for use with a wide range of DV! graphic controller boards. The display is used in dual-head configuration.

The 10MP Grayscale Flat Panel Display uses a monochrome LCD panel employing in-plane switching (IPS) technology to allow wide viewing angles. It has a resolution of 4096 x 2560 pixels and is used in landscape mode. The display uses backlight sensor to automatically stabilize the set luminance levels of the CCFL backlight over time. It also sports an integrated front sensor for independent grayscale verification. The factory calibrated gamma response is stored in five lookup tables located in the display, allowing users to adapt the display to local lighting conditions and ensuring that the display function is DICOM compliant regardless of the display controller used.

The 10MP Grayscale Flat Panel Display may be offerent housing colors and with different logos. These cosmetic differences are reflected in the designators represented by the characters "$" and "#" included in the model trade name 6GF6201-8C$#, where $ represents a letter between A and Z, and # is a number between 0 and 9.

The 10MP Grayscale Flat Panel Display uses the same LCD panel from the same manufactorer as the predicate device and employs CCFL backlight technology. It is equipped with two integrated luminance sensors, one mounted rear center and a built in front sensor, as included with the Coronis Fusion 10MP.

The housing, stand, electronics and the integrated luminance sensors are not the same as those components used in the predicate devices. The overall design of the 6GF6201-8C$## was validated in accordance with internationally recognized safety and EMC standards by independent testing facilities and inhouse. Additionally, EIZO GmbH performed a range of system and performance tests to ensure that the 10MP Grayscale Flat Panel Display performed in accordance with its specifications.

While the predicate device is equipped with a proprietary high speed display controller, the 6GF6201-8CS## was designed to receive and display images from standard, commercial DVI display controllers.

The provided document is an Abbreviated 510(k) Summary for a medical display device, the EIZO 10MP Grayscale Flat Panel Display (GX1030). It is not a study report for an AI-powered device, but rather a regulatory submission for a display device.

Therefore, the document does not contain the information required to answer your request about acceptance criteria and a study proving an AI device meets them. Specifically:

• No AI device: The device described is a medical display, not an AI algorithm.
• No acceptance criteria for an AI algorithm: The document focuses on the display's technical characteristics and substantial equivalence to a predicate device, not on clinical performance metrics for an AI.
• No study proving AI device performance: The "tests" mentioned are related to safety, EMC, and display performance (e.g., luminance stability, gamma response), not on the diagnostic accuracy of an AI.
• No information on sample sizes (test/training sets), experts, adjudication methods, MRMC studies, or ground truth for an AI.

The document states:

• "EIZO GmbH performed a range of system and performance tests to ensure that the 10MP Grayscale Flat Panel Display performed in accordance with its specifications."
• "None of the tests revealed behaviors inconsistent with the expected performance of a 10MP grayscale flat panel display."

These statements refer to the display's technical performance validation, not a clinical study to evaluate an AI's diagnostic abilities.

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The 5MP Grayscale Flat Panel Display is intended to be used in displaying and viewing digital images, including digital mammography, for review, analysis and diagnosis by trained medical practitioners.

The 6GF6201-5C$2# is a diagnostic 5MP grayscale flat panel display for viewing medical images. With the calibrated gamma response stored in five internal lookup tables, the display is suitable for use with a wide range of DVI graphic controller boards. The display can be used in single-head or multi-head configurations.

This document is a 510(k) summary for the EIZO 6GF6201-5C$2# 5MP Grayscale Flat Panel Display. It details the device's characteristics, intended use, and substantial equivalence to predicate devices, but it does not contain a study that proves the device meets specific acceptance criteria related to its performance in medical image interpretation.

Instead, this document focuses on demonstrating substantial equivalence to previously cleared devices (Coronis 5MP (K042221) and Nio 5MP-M-21" (K062131)) based on technical characteristics, application, and intended use. The "acceptance criteria" here refer to the regulatory requirements for showing substantial equivalence for a medical device display, rather than clinical performance metrics for an AI algorithm.

Therefore, I cannot provide a "table of acceptance criteria and the reported device performance" as typically expected for an AI algorithm, nor can I answer many of the specific questions about clinical studies, ground truth, or expert involvement because this document pertains to display hardware, not an AI diagnostic tool.

However, I can extract information relevant to the regulatory approval process if that's what you're interested in.

Based on the provided text, the device is a medical display, not an AI algorithm. Therefore, many of your questions related to AI algorithm performance studies, ground truth, and expert adjudication are not applicable.

Here's an analysis of the available information in the context of a medical display device approval:

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

The document doesn't present a table of specific quantitative acceptance criteria for image interpretation performance (like sensitivity, specificity, or accuracy) because the device is a display, not a diagnostic algorithm. The acceptance criteria for a display involve technical specifications and compliance with standards.

The document states:

• "EIZO GmbH performed a range of system and performance tests to ensure that the 5MP Grayscale Flat Panel Display performed in accordance with its specifications. None of the tests revealed behaviors inconsistent with the expected performance of a 5MP grayscale flat panel display."
• "The 5MP Grayscale Flat Panel Display is substantially equivalent to the predicate devices with respect to technical characteristics, application and intended use."

Technical Characteristics and Performance (as reported for the device):

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

Not applicable. This is a display device. The "tests" mentioned were likely engineering and performance validation tests of the hardware, not clinical studies on image sets.

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. No ground truth for image interpretation was established as this is a display device.

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

Not applicable. No clinical adjudication was performed as this is a display device.

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 device, not an AI algorithm.

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

Not applicable. This is a display device, not an AI algorithm.

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

Not applicable. No ground truth for image interpretation was used. The "ground truth" for a display would refer to calibration standards and objective measurements of display characteristics (luminance, color accuracy, resolution, etc.).

8. The sample size for the training set:

Not applicable. This is a display device, not an AI algorithm that requires a training set.

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

Not applicable. This is a display device, not an AI algorithm.

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