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RadiForce RS210 is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. RadiForce RS210 does not support the display of mammography images for diagnosis.

Color LCD Monitor, RadiForce RS210

This document is an FDA 510(k) clearance letter for a medical display monitor, the Eizo RadiForce RS210. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria related to a diagnostic AI algorithm.

The letter simply states that the FDA has reviewed the manufacturer's premarket notification and determined that the device is substantially equivalent to legally marketed predicate devices. This means it has met the regulatory requirements for general controls, but there is no diagnostic algorithm being cleared or assessed for performance.

Therefore, I cannot provide the requested information, such as:

• A table of acceptance criteria and the reported device performance: This letter does not specify performance criteria for a diagnostic algorithm, as it is a monitor.
• Sample sized used for the test set and the data provenance: No diagnostic algorithm test set is described.
• Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable, as there's no diagnostic algorithm.
• Adjudication method: Not applicable.
• Multi reader multi case (MRMC) comparative effectiveness study: Not applicable.
• Standalone (i.e. algorithm only without human-in-the-loop performance) study: Not applicable.
• ** Type of ground truth used:** Not applicable.
• Sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

The "Indications for Use" section clearly states: "RadiForce RS210 is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. RadiForce RS210 does not support the display of mammography images for diagnosis." This confirms its role as a display device, not an AI diagnostic tool.

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RadiForce MX241W is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The device is not specified for digital mammography system.
RadiForce MX241W is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. RadiForce MX241W does not support the display of mammography images for diagnosis.

RadiForce MX241W is 61cm Color LCD display for medical image viewing digital images viewing.

The provided text is for a 510(k) summary for a medical display monitor (EIZO RadiForce MX241W). This type of device is a display monitor, not an AI-powered diagnostic device, and therefore the kind of study and acceptance criteria you are asking for (e.g., related to algorithm performance, expert evaluations, MRMC studies, ground truth) are not applicable or typically part of the regulatory submission for such a display device.

The 510(k) submission for a medical display focuses on demonstrating substantial equivalence to a predicate device, primarily through comparison of technical specifications and intended use.

Here's a breakdown based on the information available and what is typically expected for this type of device:

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

For a medical display, acceptance criteria typically revolve around technical specifications such as brightness, contrast ratio, resolution, color accuracy, and compliance with industry standards (e.g., DICOM Part 14 for grayscale display function). The submission primarily highlights improvements over the predicate 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 medical display device, not an image analysis or diagnostic software. Therefore, there is no "test set" of medical data in the context of diagnostic performance evaluation. The "testing" would involve electrical and optical performance measurements of the display itself.

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, as there is no "ground truth" to establish for a display device in the same way there would be for a diagnostic algorithm. Performance is based on technical specifications and adherence to standards.

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 device is a display monitor, not an AI or CAD system, so an MRMC study is not relevant.

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

Not applicable. This is hardware (a monitor), not an algorithm.

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

Not applicable.

8. The sample size for the training set

Not applicable.

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

Not applicable.

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RadiForce RX320 is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. RadiForce RX320 does not support the display of mammography images for diagnosis.

RadiForce RX320 is a 54cm (21.2") Color LCD display for medical image viewing. RX320 displays high-definition medical imaging.

The provided text describes a 510(k) summary for the EIZO NANAO CORPORATION's Color LCD Monitor, RadiForce RX320. This document primarily focuses on establishing substantial equivalence to a predicate device (RadiForce R31 and R31-C) rather than presenting a detailed study with acceptance criteria and performance data in the typical sense of a clinical trial for an AI/CAD product.

The device is a medical display monitor, and its "performance" is evaluated based on its technical specifications compared to the predicate device. The acceptance criteria essentially revolve around demonstrating that the new device meets or exceeds the specifications of the predicate device, or that any differences do not raise new questions of safety and effectiveness.

Here's a breakdown based on your request, with the understanding that the nature of the device (a monitor) means "performance" and "ground truth" are interpreted differently than for an AI diagnostic algorithm:

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

Note: The acceptance criteria here are implicitly defined by the specifications of the predicate device. The new device demonstrates "substantial equivalence" by meeting or improving upon these key specifications.

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

   • This is not applicable to a medical display monitor's 510(k) submission. The "test set" would be the device itself being tested for its physical and electrical characteristics, not a set of medical images. The document does not describe a study involving medical image data.

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 as no "ground truth" for medical image interpretation is established for this device submission. The device is a display, not a diagnostic algorithm.

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 device is a display monitor, not an AI/CAD system.

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

   • Not applicable. This is a hardware device (monitor), not an algorithm. Its "standalone performance" refers to its technical specifications (brightness, contrast, etc.) as listed in the table, which are inherently "algorithm-only" in the sense that they are physical measurements of the device's output.

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

   • Not applicable. The "ground truth" for a monitor is its adherence to technical manufacturing specifications and industry standards for display performance (e.g., luminance, contrast, resolution), measured using calibrated equipment. This document does not detail the specific test methods or "ground truth" sources used to verify these specifications, but it is implied to be standard engineering and quality control procedures.

8. The sample size for the training set:

   • Not applicable. This device does not involve machine learning algorithms.

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

   • Not applicable. No training set is involved for this device.

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RadiForce RS110 is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. RadiForce RS110 does not support the display of mammography images for diagnosis.

RadiForce RS110 is a 48cm (19") Color LCD display for medical image viewing. RS110 displays high-definition medical imaging.

This document is a 510(k) summary for the EIZO RadiForce RS110 Color LCD Monitor. It outlines the device's characteristics and its substantial equivalence to a predicate device (RadiForce R12).

However, this document does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically described for a medical imaging algorithm or diagnostic device. This document describes a monitor, which is a display device, not a diagnostic algorithm. Therefore, many of the typical acceptance criteria and study parameters you asked for (like sample size, ground truth, expert adjudication, MRMC studies) are not applicable or detailed in this type of submission for a display monitor.

Instead, the "acceptance criteria" for a medical display device like this are primarily related to its technical specifications and performance characteristics, and the "study" proving it meets these involves technical measurements and comparisons to a predicate device.

Here's an interpretation based on the provided text, addressing your points where possible and noting where information is not available or not applicable:

1. Table of acceptance criteria and the reported device performance

For a medical display monitor like the RadiForce RS110, the "acceptance criteria" are implicitly its ability to meet or exceed the performance specifications of the predicate device (RadiForce R12) and comply with general medical display standards. The reported performance is highlighted by the comparison table itself.

Study that proves the device meets the acceptance criteria:

The study is an equivalence demonstration by comparing the technical specifications of the new device (RS110) against a legally marketed predicate device (R12). The "study" is the detailed comparison table provided in Appendix 1, which shows that the RS110 either maintains or improves upon the performance characteristics of the R12, while maintaining the same intended use.

Specifically, the document states: "RadiForce R12 is substantially equivalent to RS110 employs the maximum resolution values same as that of R12. RS110 improved the brightness, contrast and viewing angle of the LCD module, and modified the calibration software." This forms the basis of their claim of equivalence and meeting (or exceeding) the implied 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 and therefore not provided in this 510(k) for a display monitor. There is no "test set" of medical images in the context of an algorithm's diagnostic performance. The testing here is of the monitor's physical and optical properties.

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)

This information is not applicable. Ground truth, expert consensus, and radiologists are relevant for evaluating diagnostic algorithms, not for the technical specifications of a display monitor. The "ground truth" for a monitor is its measured physical performance characteristics.

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

This information is not applicable. Adjudication methods are used in diagnostic studies, not for the technical evaluation of a monitor's specifications.

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

This information is not applicable. MRMC studies are for evaluating the impact of a diagnostic tool (like AI) on reader performance. This document is for a display monitor, which is a passive viewing instrument.

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

This information is not applicable. This is not an algorithm; it's a hardware display device.

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

The "ground truth" for a display monitor's performance is essentially the physical measurements of its technical specifications (brightness, contrast, viewing angles, resolution, power consumption, etc.) using calibrated equipment and standard test patterns. These measurements are then compared against the predicate device's specifications and relevant industry standards for medical displays.

8. The sample size for the training set

This information is not applicable. Training sets are used for machine learning algorithms. This device is a display monitor.

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

This information is not applicable. As there is no training set for a display monitor, there's no ground truth for it to be established either.

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RadiForce RX211 is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. RadiForce RX211 does not support the display of mammography images for diagnosis.

RadiForce RX211 is a 54cm (21.3") Color LCD display for medical image viewing. RX211 displays high-definition medical imaging.

The provided document is a 510(k) summary for a medical display monitor (Color LCD Monitor, RadiForce RX211), not an AI/ML device. Therefore, much of the requested information regarding AI/ML device performance, ground truth, and study design (e.g., MRMC studies, standalone performance, training sets) is not applicable or present in this document.

The document focuses on demonstrating substantial equivalence to a predicate device (RadiForce RX210) by comparing technological characteristics, primarily brightness and contrast.

Here's an attempt to answer the applicable questions based on the provided text, with clarifications where the information is not relevant to this type of device:

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

The document does not explicitly state "acceptance criteria" in the traditional sense of a performance study for an AI algorithm. Instead, it compares the technological characteristics of the new device (RX211) to its predicate device (RX210) to demonstrate substantial equivalence. The "performance" here refers to specific technical specifications.

Note: The document states "The brightness improved in 750 cd/m2 from 600 cd/m2. The contrast improved by it." indicating an improvement over the predicate, which serves as the "acceptance" benchmark for equivalence in this context.

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

The concept of a "test set" in the context of an AI/ML study is not applicable here. This is a hardware device review. There are no images or clinical data used as a "test set" for performance evaluation in this 510(k) submission.

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

Not applicable. Ground truth and expert consensus are irrelevant for a medical display monitor's technical specifications.

4. Adjudication method for the test set

Not applicable. There is no test set or adjudication performed in this context.

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 medical display monitor, not an AI-assisted diagnostic device. Therefore, no MRMC study looking at human reader improvement with AI was conducted or is relevant.

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

Not applicable. This is a hardware device, not an algorithm.

7. The type of ground truth used

Not applicable. Ground truth is not a concept used in the regulatory review of a medical display monitor's technical specifications.

8. The sample size for the training set

Not applicable. There is no training set for a medical display monitor.

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

Not applicable. There is no training set or ground truth for a medical display monitor.

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FlexScan MX300W is intended to be used in displaying digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. FlexScan MX300W does not support the display of mammography images for diagnosis.

FlexScan MX300W is a 76cm (29.8") Color LCD display for medical image viewing and digital images viewing. MX300W displays high-definitions medical imaging.

The provided text is a 510(k) summary for a medical monitor (Color LCD Monitor, FlexScan MX300W). It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about a study that assesses the device's performance against specific acceptance criteria related to its diagnostic accuracy or the impact of AI on human readers.

This type of submission for a display device primarily focuses on technical specifications and demonstrating that the new device is substantially equivalent to an already approved predicate device. It doesn't involve the kind of comparative effectiveness studies or standalone algorithm performance evaluations that would be documented for an AI-powered diagnostic device.

Therefore, I cannot provide the requested information from the given text. The text does not contain:

1. A table of acceptance criteria and reported device performance: This would typically involve metrics like sensitivity, specificity, accuracy, or other performance indicators, which are not discussed for this monitor.
2. Sample size used for the test set and data provenance: No test sets are described for evaluating diagnostic performance.
3. Number of experts used to establish ground truth and their qualifications: Ground truth establishment is not relevant in this context for a monitor.
4. Adjudication method: Not applicable.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: This is a display device, not an AI diagnostic algorithm, so no such study is described. There's no mention of AI or its effect on human readers.
6. Standalone (algorithm only without human-in-the-loop performance) study: Not applicable, as this is a display device, not an algorithm.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How ground truth for the training set was established: Not applicable.

The 510(k) summary focuses on the monitor's technical characteristics (e.g., panel size, resolution, Digital Uniformity Equalizer, brightness) and its intended use for displaying digital images for diagnosis by trained medical practitioners, specifically excluding mammography. It establishes substantial equivalence to the RadiForce R31 monitor (K052344) based on these technical aspects.

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RadiForce RX210 is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The device is not specified for digital mammography system.

RadiForce RX210 is a 54cm (21.3") Color LCD display for medical image viewing. RX210 displays high-definition medical imaging.

This is a 510(k) premarket notification for a medical display, not a medical device that performs diagnostic analysis. Therefore, the traditional acceptance criteria and study design for evaluating diagnostic performance (like those involving sensitivity, specificity, expert readers, etc.) are not applicable here.

The document describes the RadiForce RX210 Color LCD Monitor and establishes its substantial equivalence to a predicate device (RadiForce R22, K033466) based on technological characteristics and intended use.

Here's the information derived from the provided text, adapted to the context of a medical display’s regulatory review:

1. Acceptance Criteria and Reported Device Performance (Focus on Substantial Equivalence)

For medical displays, acceptance criteria typically revolve around demonstrating that the new device performs at least as well as, or is substantially equivalent to, an already legally marketed predicate device, especially in key performance parameters relevant to image display for diagnosis.

Study Proving Acceptance Criteria (Substantial Equivalence Justification):

The "study" in this context is the comparison presented in the 510(k) submission, primarily in the form of a comparison table (Appendix 1 / {1}) and a narrative describing the technological characteristics and intended use. It demonstrates that the new device, RadiForce RX210, is substantially equivalent to the predicate device, RadiForce R22 (K033466).

The key argument is that the RX210 maintains the core functional aspects (like resolution, panel type, pixel pitch) of the predicate device while introducing improvements (higher brightness, contrast, faster response time, and the addition of Digital Uniformity Equalizer (DUE) for luminance non-uniformity compensation). The intended use is identical, and the software for calibration remains unchanged.

Regarding the other requested information (which are generally not applicable to this type of device submission):

• 2. Sample sized used for the test set and the data provenance: Not applicable. This submission is for a display monitor, not an algorithm or diagnostic test evaluated on a dataset of patient images. The "test" is a comparison of technical specifications against a predicate device.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no ground truth in the sense of diagnostic accuracy for a display monitor itself. The "ground truth" here is the established performance and safety of the predicate device.
• 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 not an AI-enabled diagnostic device.
• 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a hardware device for display, not an algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): As noted in point 3, traditional ground truth for diagnostic accuracy is not relevant here. The ground truth for this submission is the regulatory acceptance and safety/effectiveness of the predicate device, against which the new device's technical specifications are compared.
• 8. The sample size for the training set: Not applicable. This is not a machine learning device.
• 9. How the ground truth for the training set was established: Not applicable.

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RadiForce R31 and R31-C are intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. These devices must not be used for digital mammography system.

RadiForce R31 and R31-C are 53cm (20.8") Color LCD displays for medical viewing. Each model produces hi·crisp images for modality applications and 3D image fusion. The model difference between R31 and R31-C are the panel protector provided with R31-C and brightness only.

This 510(k) premarket notification (K052344) is for a medical display device, the EIZO NANAO CORPORATION’s Color LCD Monitor, RadiForce R31 and R31-C. It does not contain information about an AI/ML device or its performance study. Therefore, I cannot accurately answer your request.

Medical displays like the RadiForce R31 are evaluated based on display hardware performance specifications (e.g., luminance, resolution, contrast ratio, uniformity, color accuracy) and their ability to render medical images accurately, not on clinical performance metrics like diagnostic accuracy, sensitivity, or specificity that would be generated from a study involving image interpretation by human readers or an AI algorithm.

The provided documentation does not include:

• Acceptance criteria and reported device performance in terms of clinical outcomes or diagnostic accuracy.
• Sample sizes for test sets, data provenance, or ground truth establishment.
• Details about expert involvement, adjudication methods, or MRMC studies.
• Standalone algorithm performance or training set information.

Instead, the documentation focuses on the substantial equivalence of the new device to a predicate device (RadiForce R22) based on technical characteristics and intended use for displaying digital images for diagnosis.

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RadiForce R12 is intended to be used in displaying for diagnosis of X-ray or MRI, etc. The product is not intended for use with a digital mammography system.

Color LCD Monitor, RadiForce R12

This document is an FDA 510(k) clearance letter for a medical device: an Eizo Nanao Corporation Color LCD Monitor, RadiForce R12.

Based on the provided text, there is NO information available regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

This letter is a regulatory document confirming that the device is substantially equivalent to legally marketed predicate devices and can be marketed. It does not contain the detailed technical or clinical study data that would typically define acceptance criteria or describe a study's methodology and results.

The "Indications for Use" section (Page 2) states: "RadiForce R12 is intended to be used in displaying for diagnosis of X-ray or MRI, etc. The product is not intended for use with a digital mammography system." This specifies the intended clinical application but does not provide performance metrics or acceptance criteria.

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